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1.	Adolfsson, Peter, 1963, et al. (författare) Accuracy and reliability of continuous glucose monitoring in individuals with type 1 diabetes during recreational diving 2009 Ingår i: Diabetes Technology & Therapeutics. - : Mary Ann Liebert. - 1557-8593 .- 1520-9156. ; 11:8, s. 493-7 Tidskriftsartikel (refereegranskat)abstract BACKGROUND: This study evaluated the accuracy and function of the Continuous Glucose Monitoring System (CGMS, Minneapolis, MN) during recreational scuba diving in individuals with type 1 diabetes. METHODS: Twenty-four adults, 12 with type 1 diabetes and 12 healthy controls, were studied during five recreational scuba dives performed on three consecutive days. All the participants used the CGMS on all the days and during all the dives. Comparisons were made between plasma glucose at specific time intervals and the CGMS. RESULTS: The recording by the CGMS was robust, with few sensor problems. The mean sensor survival time was >48 h. Eighty-five percent of the individuals used one sensor during the entire length of the trial. The overall mean absolute difference (MAD) within the group with diabetes was 14.4 +/- 6%, and the corresponding daily figures were 23.2 +/- 19.3% on day 1, 11.6 +/- 4.5% on day 2, and 11.2 +/- 5.7% on day 3. A significant improvement regarding MAD when day 1 was compared with day 2 and 3 (P < 0.05). With a limit set at 70 mg/dL, hypoglycemia pre- and post-dive was detected with a positive predictive value of 0.39, negative predictive value of 0.98, sensitivity of 0.64, and specificity of 0.94. CONCLUSIONS: We demonstrate that the CGMS was used with accuracy in such difficult conditions as scuba diving and provided robust information on glucose variations.
2.	Adolfsson, Peter, 1963, et al. (författare) Continuous Glucose Monitoring-A Study of the Enlite Sensor During Hypo- and Hyperbaric Conditions 2012 Ingår i: Diabetes Technology & Therapeutics. - New Rochelle, USA : Mary Ann Liebert Inc. - 1520-9156 .- 1557-8593. ; 14:6, s. 527-532 Tidskriftsartikel (refereegranskat)abstract Background: The performance and accuracy of the Enlite (TM) (Medtronic, Inc., Northridge, CA) sensor may be affected by microbubble formation at the electrode surface during hypo- and hyperbaric conditions. The effects of acute pressure changes and of prewetting of sensors were investigated. Materials and Methods: On Day 1, 24 sensors were inserted on the right side of the abdomen and back in one healthy individual; 12 were prewetted with saline solution, and 12 were inserted dry. On Day 2, this procedure was repeated on the left side. All sensors were attached to an iPro continuous glucose monitoring (CGM) recorder. Hypobaric and hyperbaric tests were conducted in a pressure chamber, with each test lasting 105 min. Plasma glucose values were obtained at 5-min intervals with a HemoCue (R) (Angelholm, Sweden) model 201 glucose analyzer for comparison with sensor glucose values. Results: Ninety percent of the CGM systems operated during the tests. The mean absolute relative difference was lower during hyperbaric than hypobaric conditions (6.7% vs. 14.9%, P<0.001). Sensor sensitivity was slightly decreased (P<0.05) during hypobaric but not during hyperbaric conditions. Clarke Error Grid Analysis showed that 100% of the values were found in the A+B region. No differences were found between prewetted and dry sensors. Conclusions: The Enlite sensor performed adequately during acute pressure changes and was more accurate during hyperbaric than hypobaric conditions. Prewetting the sensors did not improve accuracy. Further studies on type 1 diabetes subjects are needed under various pressure conditions.
3.	Adolfsson, Peter, 1963, et al. (författare) Evaluation of glucose control when a new strategy of increased carbohydrate supply is implemented during prolonged physical exercise in type 1 diabetes 2015 Ingår i: European Journal of Applied Physiology. - New York, USA : Springer. - 1439-6319 .- 1439-6327. ; 115:12, s. 2599-2607 Tidskriftsartikel (refereegranskat)abstract Purpose: In healthy individuals, high carbohydrate intake is recommended during prolonged exercise for maximum performance. In type 1 diabetes (T1D), this would alter the insulin requirements. The aim of the study was to evaluate the safety of high glucose supplementation during prolonged exercise and the glucose control when a novel strategy of increased carbohydrate supply was implemented during prolonged exercise in T1D.Methods: Eight subjects with T1D participated in a sports camp including sessions of prolonged exercise and individualized feedback during three consecutive days. This was later followed by a 90 km cross-country skiing race. Large amounts of carbohydrates, 75 g/h, were supplied during exercise and the insulin requirements were registered. Glucose was measured before, during and after exercise aiming at euglycaemia, 4-8 mmol/L (72-144 mg/dL). During the race, continuous glucose monitoring (CGM) was used as an aspect of safety and to allow direct and individual adjustments.Results: Compared to ordinary carbohydrate supply during exercise, the high carbohydrate supplementation resulted in significantly increased insulin doses to maintain euglycaemia. During the cross-country skiing race, the participants succeeded to reach mean target glucose levels; 6.5 ± 1.9 mmol/L (117 ± 34 mg/dL) and 5.7 ± 1.5 mmol/L (103 ± 27 mg/dL) at the start and finish of the race, respectively. Episodes of documented hypoglycemia (<4 mmol/L/72 mg/dL) were rare. CGM was used for adjustments.Conclusion: In this study, large carbohydrate supplementation in T1D individuals during prolonged aerobic exercise is safe and allows the subjects to maintain glycaemic control and indicates the feasibility of CGM under these conditions.
4.	Adolfsson, Peter, 1963, et al. (författare) In-vitro performance of the Enlite sensor in various glucose concentrations during hypobaric and hyperbaric conditions 2012 Ingår i: Journal of Diabetes Science and Technology. - Thousand Oaks, USA : Sage Publications. - 1932-2968. ; 6:6, s. 1375-1382 Tidskriftsartikel (refereegranskat)abstract Background: There is a need for reliable methods of glucose measurement in different environmental conditions. The objective of this in vitro study was to evaluate the performance of the Enlite® Sensor when connected to either the iPro™ Continuous Glucose Monitor recording device or the Guardian® REAL-Time transmitting device, in hypobaric and hyperbaric conditions.Methods: Sixteen sensors connected to eight iPro devices and eight Guardian REAL-Time devices were immersed in three beakers containing separate glucose concentrations: 52, 88, and 207 mg/dl (2.9, 4.9, and 11.3 mmol/liter). Two different pressure tests were conducted: a hypobaric test, corresponding to maximum 18000 ft/5500 m height, and a hyperbaric test, corresponding to maximum 100 ft/30 m depth. The linearity of the sensor signals in the different conditions was evaluated.Results: The sensors worked continuously, and the sensor signals were collected without interruption at all pressures tested. When comparing the input signals for glucose (ISIGs) and the different glucose concentrations during altered pressure, linearity (R(2)) of 0.98 was found. During the hypobaric test, significant differences (p < .005) were seen when comparing the ISIGs during varying pressure at two of the glucose concentrations (52 and 207 mg/dl), whereas no difference was seen at the 88 mg/dl glucose concentration. During the hyperbaric test, no differences were found.Conclusions: The Enlite Sensors connected to either the iPro or the Guardian REAL-Time device provided values continuously. In hyperbaric conditions, no significant differences were seen during changes in ambient pressure; however, during hypobaric conditions, the ISIG was significantly different in the low and high glucose concentrations.
5.	Adolfsson, Peter, 1963, et al. (författare) The benefits of continuous glucose monitoring and a glucose monitoring schedule in individuals with type 1 diabetes during recreational diving 2008 Ingår i: Journal of Diabetes Science and Technology. - : Diabetes Technology Society. - 1932-2968. ; 2:5, s. 778-784 Tidskriftsartikel (refereegranskat)abstract BACKGROUND: Our objective is to evaluate the Medtronic CGMS continuous glucose monitoring system and plasma glucose (PG) measurement performed in a monitoring schedule as tools to identify individuals with type 1 diabetes at risk when diving.METHODS: We studied 24 adults, 12 type 1 diabetes subjects and 12 controls, during 5 recreational scuba dives performed on 3 consecutive days. The CGMS was used by all participants on all the days and all the dives. Comparisons were made between PG performed in a monitoring schedule during the days of diving, self-monitored blood glucose (SMBG) performed 2 weeks prior to diving, and the CGMS during the study.RESULTS: One hundred seventeen dives were performed. Hypoglycemia (<70 mg/dl) was found in six individuals and on nine occasions. However, no symptoms of hypoglycemia were present during or immediately postdiving. In one case, repetitive hypoglycemia prediving gave rise to a decision not to dive. None of the dives were aborted. The number of hypoglycemic episodes, 10 min prediving or immediately postdiving, were related to the duration of diabetes, r = 0.83 and p =0.01, and the percentage of SMBG values below target (<72 mg/dl), r = 0.65 and p =0.02. Moreover, the number of hypoglycemic episodes was also related to the total duration below low limit (<70 mg/dl), measured by the CGMS, r =0.74 and p =0.006.CONCLUSION: Safe dives are possible to achieve by well-informed, well-controlled individuals with type 1 diabetes. Using downloaded SMBG, CGMS, and repetitive PG in a monitoring schedule, it is possible to identify those subjects who are suitable for diving.
6.	Jendle, Johan, 1963-, et al. (författare) A narrative commentary about interoperability in medical devices and data used in diabetes therapy from an academic EU/UK/US perspective 2024 Ingår i: Diabetologia. - : Springer. - 0012-186X .- 1432-0428. ; 67:2, s. 236-245 Forskningsöversikt (refereegranskat)abstract People living with diabetes have many medical devices available to assist with disease management. A critical aspect that must be considered is how systems for continuous glucose monitoring and insulin pumps communicate with each other and how the data generated by these devices can be downloaded, integrated, presented and used. Not only is interoperability associated with practical challenges, but also devices must adhere to all aspects of regulatory and legal frameworks. Key issues around interoperability in terms of data ownership, privacy and the limitations of interoperability include where the responsibility/liability for device and data interoperability lies and the need for standard data-sharing protocols to allow the seamless integration of data from different sources. There is a need for standardised protocols for the open and transparent handling of data and secure integration of data into electronic health records. Here, we discuss the current status of interoperability in medical devices and data used in diabetes therapy, as well as regulatory and legal issues surrounding both device and data interoperability, focusing on Europe (including the UK) and the USA. We also discuss a potential future landscape in which a clear and transparent framework for interoperability and data handling also fulfils the needs of people living with diabetes and healthcare professionals.
7.	Jendle, Johan, 1963-, et al. (författare) Continuous Glucose Monitoring Diving and Diabetes : An Update of the Swedish Recommendations 2020 Ingår i: Journal of Diabetes Science and Technology. - : Diabetes Technology Society. - 1932-2968. ; 14:1, s. 170-173 Tidskriftsartikel (refereegranskat)abstract Divers travel to different countries to explore various diving sites worldwide. In 2005, the Divers Alert Network (DAN) published their guidelines for recreational diving and diabetes mellitus. However, although years have passed, there is still no consensus in the form of international guidelines on diabetes and diving. Large differences are noted with regard to the regulations in different countries. Furthermore, the diabetes technology has evolved rapidly and is not reflected in current international guidelines. This is potentially both a medical and an insurance problem for a diver with diabetes. We present a short summary of the recently updated Swedish recommendations for recreational divers with type 1 diabetes mellitus, focusing on the use of continuous glucose monitoring and continuous subcutaneous insulin infusion during such circumstances.
8.	Jendle, Johan, 1963-, et al. (författare) Impact of high altitudes on glucose control. 2011 Ingår i: Journal of diabetes science and technology. - : Diabetes Technology Society. - 1932-2968. ; 5:6, s. 1621-2 Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
9.	Jendle, Johan, 1963-, et al. (författare) Patterns and Predictors Associated With Long-Term Glycemic Control in Pediatric and Young Adult Patients with Type 1 Diabetes 2022 Ingår i: Journal of Diabetes Science and Technology. - Thousand Oaks, CA : Sage Publications. - 1932-2968. ; 17:5, s. 1243-1251 Tidskriftsartikel (refereegranskat)abstract Background: The development of diabetes technology is rapid and requires education and resources to be successfully implemented in diabetes care management.Method: In an observational study, we evaluated the use of advanced diabetes technology, resource utilization, and glycemic control. The study population was 725 individuals with type 1 diabetes (T1D) living in Region Halland, Sweden. The study cohort was followed for 7 years between 2013 and 2019.Results: Children aged 0 to 17 years were associated with significantly better glucose control than young adults aged 18 to 25 years. The mean HbA1c in children and young adults was 53 mmol/mol (7.0%) compared to 61 mmol/mol (7.7%) (P <.0001), respectively. Comorbidities such as attention deficit hyperactivity disorder (ADHD), autism, and coelic disease were associated with higher HbA1c. All groups, regardless of age and comorbidity, showed a positive effect on glucose control after visiting a dietitian or psychologist. Differences were found between the age groups in terms of more use of advanced diabetes technology and more frequent visits to a physician in children compared to young adults.Conclusions: More frequent visits to physicians, and a visit to dietitians, and psychologists were associated with improved glucose control in individuals with T1D 0 to 25 years. Increased resources, including access to more advanced technologies, may be required in young adults with T1D. © 2022 Diabetes Technology Society.
10.	Jendle, Johan, 1963-, et al. (författare) Recreational diving in persons with type 1 and type 2 diabetes: Advancing capabilities and recommendations 2020 Ingår i: Diving and Hyperbaric Medicine. - : Diving and Hyperbaric Medicine Journal. - 1833-3516 .- 2209-1491. ; 50:2, s. 135-143 Tidskriftsartikel (refereegranskat)abstract Diving by persons with diabetes has long been conducted, with formal guidelines published in the early 1990s. Subsequent consensus guidelines produced following a 2005 workshop helped to advance the recognition of relevant issues and promote discussion. The guidelines were intended as an interim step in guidance, with the expectation that revisions should follow the gathering of additional data and experience. Recent and ongoing developments in pharmacology and technology can further aid in reducing the risk of hypoglycaemia, a critical acute concern of diving with diabetes. Careful and periodic evaluation remains crucial to ensure that participation in diving activity is appropriate. Close self-monitoring, thoughtful adjustments of medications and meals, and careful review of the individual response to diving can assist in optimising control and ensuring safety. Open communication with diving partners, support personnel, and medical monitors is important to ensure that all are prepared to effectively assist in case of need. Ongoing vigilance, best practice, including graduated clearance for diving exposures and adverse event reporting, are all required to ensure the safety of diving with diabetes and to promote community understanding and acceptance.
11.	Jendle, Johan, 1963-, et al. (författare) Swedish recommendations on recreational diving and diabetes mellitus. 2012 Ingår i: Diving and hyperbaric medicine : the journal of the South Pacific Underwater Medicine Society. - Melbourne, Australia : South Pacific Underwater Medicine Society Inc.. - 1833-3516. ; 42:4, s. 231-3 Tidskriftsartikel (refereegranskat)abstract Divers from many countries travel to explore various diving sites worldwide. In 2005, the Divers Alert Network (DAN) wrote guidelines for recreational diving and diabetes mellitus, but there is no up-to-date consensus or adoption of international guidelines on diabetes and diving. There are also large differences between the regulations in different countries. This is potentially both a medical and an insurance problem for a diver with diabetes. We present the current Swedish recommendations for recreational divers with Type 1 diabetes mellitus.
12.	Khalili, Payam, 1977-, et al. (författare) Combined effects of brachial pulse pressure and sialic acid for risk of cardiovascular events during 40 years of follow-up in 37 843 individuals 2012 Ingår i: Journal of Hypertension. - Philadelphia, USA : Lippincott Williams & Wilkins. - 0263-6352 .- 1473-5598. ; 30:9, s. 1718-1724 Tidskriftsartikel (refereegranskat)abstract Objective: Pulse pressure (PP) is a risk marker for cardiovascular disease (CVD) in individuals 50 years and older. Inflammation is suggested to influence atherosclerosis, but could also increase PP. We aimed to examine the combined effects of PP and the inflammatory marker sialic acid, and their independent roles on CVD risk. Methods: From a population-based study in Sweden between 1962 and 1965, 18 429 men and 19 414 women at the age of 50 or older were selected and followed for first CVD event until 2005. We investigated the biological interactions between sialic acid and PP. The associations of PP and sialic acid with risk of CVD were calculated by using Cox proportional hazards model. Adjustments were made for conventional risk factors, mean arterial pressure (MAP) and socioeconomic status. Results: The mean age was 59.5 (SD 6.5) years and the number of incident CVD events in men and women were 3641 and 3227, respectively. No biological interaction was seen between PP and sialic acid. In men, the adjusted hazard ratio for PP was 0.92 [95% confidence interval (CI) 0.88-0.96, P < 0.0001) for 1 SD of PP, and 1.09 (95% CI 1.05-1.13, P < 0.0001) for 1 SD of sialic acid. In women, the corresponding figures were 1.02 (95% CI 0.97-1.07, P = 0.48) and 1.09 (95% CI 1.05-1.13, P < 0.0001). Conclusions: Sialic acid but not PP was an independent risk factor for CVD. The risk induced by PP is highly affected by MAP. This suggests that both estimated arterial stiffness and inflammation contribute through different pathways to risk of CVD.
13.	Khalili, Payam, 1977-, et al. (författare) Sialic acid and incidence of hospitalization for diabetes and its complications during 40-years of follow-up in a large cohort : The Värmland survey 2014 Ingår i: Primary Care Diabetes. - : Elsevier BV. - 1751-9918 .- 1878-0210. ; 8:4, s. 352-357 Tidskriftsartikel (refereegranskat)abstract Aim: To examine the association of sialic acid (SA) with first recorded diabetes mellitus-related hospitalization.Methods: From a population-based study in Varmland, Sweden, between 1962 and 1965, 87,035 men and women were selected and followed for first recorded diabetes-related hospitalization until 2005. The association of SA was calculated and stratified for gender by Cox's proportional hazards models. Adjustments were made for conventional risk factors and socioeconomic status. Association analyses were made for comparisons between SA-levels above and below median.Results: The mean age was 47.2 (SD 13.0) years and the total numbers of incident diabetes-related hospitalizations in men and women were 3445 and 3273, respectively. Hazard ratios per one standard deviation of SA were 1.12 (95% CI: 1.08-1.17, p < 0.0001) in men and 1.17 (95% CI: 1.13-1.22, p < 0.0001) in women. Interaction analyses indicated a relatively higher SA-associated risk in women than in men with above median SA levels.Conclusions: In this large population-based cohort followed for more than 40 years, elevated SA, as a marker of systemic inflammation, was independently associated with risk of diabetes and diabetes-related hospitalizations. (C) 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.
14.	Khalili, Payam, et al. (författare) Siliac-acid and incidence of hospitalization for diabetes and its complications during 40-years of follow-up in a large cohort : the Värmland survey Annan publikation (övrigt vetenskapligt/konstnärligt)abstract Aim To examine the association of sialic acid (SA) with first recorded diabetes mellitus-related hospitalization.Methods From a population-based study in Värmland, Sweden, between 1962 and 1965, 87,035 men and women were selected and followed for first recorded diabetesrelated hospitalization until 2005. The association of SA was calculated and stratified for gender by Cox´s proportional hazards models. Adjustments were made for conventional risk factors and socioeconomic status. Association analyses were made for comparisons between SA-levels above and below median.Results The mean age was 47.2 (SD 13.0) years and the total numbers of incident diabetes-related hospitalizations in men and women were 3445 and 3273, respectively. Hazard ratios per one standard deviation of SA were 1.12 (95% CI: 1.08 to 1.17, p<0.0001) in men and 1.17 (95% CI: 1.13 to 1.22, p<0.0001) in women. Interaction analyses indicated a relatively higher SA-associated risk in women than in men with above median SA levels.Conclusions In this large population-based cohort followed for more than 40 years, elevated SA, as a marker of systemic inflammation, was independently associated with risk of diabetes and diabetes-related hospitalizations.
15.	Klonoff, D. C., et al. (författare) A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings 2022 Ingår i: Journal of Diabetes Science and Technology. - : SAGE Publications. - 1932-2968. Tidskriftsartikel (refereegranskat)abstract Background: A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data. Methods: We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low–glucose and low-glucose hypoglycemia; very high–glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation. Results: The analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals. Conclusion: The GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.
16.	Mattsson, Stig, 1962-, et al. (författare) Carbohydrate Loading Followed by High Carbohydrate Intake During Prolonged Physical Exercise and Its Impact on Glucose Control in Individuals With Diabetes Type 1-An Exploratory Study 2019 Ingår i: Frontiers in Endocrinology. - : Frontiers Media SA. - 1664-2392. ; 10 Tidskriftsartikel (refereegranskat)abstract Background: Prolonged physical exercise (PE) is a challenge in type 1 diabetes with an increased incidence of both hypoglycemia and hyperglycemia. Purpose: To evaluate the impact of two consecutive days of carbohydrate (CHO) loading, followed by high intermittent CHO-intake during prolonged PE, facilitated by a proactive use of Real-Time Continuous Glucose Monitoring (rtCGM), on glucose control in individuals with type 1 diabetes. Methods: Ten physically active individuals with type 1 diabetes were invited to participate in a 3-day long sports camp with the objective to evaluate CHO-loading and high intermittent CHO-intake during prolonged PE. 1.5 months later the same procedure was evaluated in relation to a 90 km cross-country skiing race (Vasaloppet). Participants were instructed to act proactively using rtCGM with predictive alerts to maintain sensor glucose values within target range, defined as 72-180 mg/dl (4-10 mmol/l). Results: Mean glucose values during CHO-loading were: day 1; 140.4 +/- 45.0 mg/dl (7.8 +/- 2.5 mmol/l) and day 2; 120.6 +/- 41.4 mg/dl (6.7 +/- 2.3 mmol/l). Mean sensor glucose at start of PE was 126.0 +/- 25.2 mg/dl (7.0 +/- 1.4 mmol/l) and throughout PE 127.8 +/- 25.2 mg/dl (7.1 +/- 1.4 mmol/l). Percentage of time spent in range (TIR) respective time spent in hypoglycemia was: CHO-loading 74.7/10.4% and during PE 94.3/0.6%. Conclusions: High intermittent CHO-intake during prolonged PE combined with proactive use of rtCGM is associated with good glycemic control during prolonged exercise in individuals with diabetes type 1. However, the time spent in hypoglycemia during the 2-days of CHO-loading was 10.4% and therefore a lower insulin dose might be suggested to reduce the time spent in hypoglycemia.
17.	Mattsson, Stig, 1962-, et al. (författare) Empowered by Intertwined Theory and Practice : Experiences From a Diabetes Sports Camp for Physically Active Adults With Type 1 Diabetes 2021 Ingår i: Frontiers in Clinical Diabetes and Healthcare. - : Frontiers Media S.A.. - 2673-6616. ; 2 Tidskriftsartikel (refereegranskat)abstract Aims: To describe the experiences of individuals with diabetes type 1 (T1D) participating in diabetes sports camps and how acquired knowledge could be used in daily self-management.Methods: Semi-structured telephone interviews were conducted with 15 adults with T1D. A strategic sample procedure was chosen. The interviews were analyzed using qualitative content analysis.Results: The overarching theme ”Empowered by intertwined theory and practice”, included three main categories: Learning in a motivation-enhancing environment, incorporation of new habits and perceptions of glycemic control and health-related outcomes. The participants considered the camp to be an excellent opportunity to share feelings, ideas, and knowledge. They felt empowered by the camp atmosphere as well as supportive environment. After the camp, the general well-being was improved by incorporating new habits and improvements in glucose control.Conclusions: A diabetes sports camp constitutes an excellent, but resource-intensive, complimentary support in diabetes care and provides opportunities for T1D individuals to become more independent and autonomous. The findings indicate the need for more directed learning activities for individuals with type 1 diabetes and health care providers to increase their competence in the area of T1D and exercise in order to adequately manage counseling in various types of sports.
18.	Nyström, Thomas, et al. (författare) Effects on Subclinical Heart Failure in Type 2 Diabetic Subjects on Liraglutide Treatment vs. Glimepiride Both in Combination with Metformin : A Randomized Open Parallel-Group Study 2017 Ingår i: Frontiers in Endocrinology. - : Frontiers Media S.A.. - 1664-2392. ; 8 Tidskriftsartikel (refereegranskat)abstract Objective: We aimed to investigate the effect of liraglutide treatment on heart function in type 2 diabetes (T2D) patients with subclinical heart failure.Methods: Randomized open parallel-group trial. 62 T2D patients (45 male) with subclinical heart failure were randomized to either once daily liraglutide 1.8 mg, or glimepiride 4 mg, both add on to metformin 1 g twice a day. Mitral annular systolic (s') and early diastolic (e') velocities were measured at rest and during bicycle ergometer exercise, using tissue Doppler echocardiography. The primary endpoint was 18-week treatment changes in longitudinal functional reserve index (LFRIdiastolic/systolic).Results: Clinical characteristics between groups (liraglutide = 33 vs. glimepiride = 29) were well matched. At baseline left ventricle ejection fraction (53.7 vs. 53.6%) and global longitudinal strain (-15.3 vs. -16.5%) did not differ between groups. There were no significant differences in mitral flow velocities between groups. For the primary endpoint, there was no treatment change [95% confidence interval] for: LFRIdiastolic (-0.18 vs. -0.53 [-0.28, 2.59; p = 0.19]), or LFRIsystolic (-0.10 vs. -0.18 [-1.0, 1.7; p = 0.54]); for the secondary endpoints, there was a significant treatment change in respect of body weight (-3.7 vs. -0.2 kg [-5.5, -1.4; p = 0.001]), waist circumference (-3.1 vs. -0.8 cm [-4.2, -0.4; p = 0.019]), and heart rate (HR) (6.3 vs. -2.3 bpm [-3.0, 14.2; p = 0.003]), with no such treatment change in hemoglobin A1c levels (-11.0 vs. -9.2 mmol/mol [-7.0, 2.6; p = 0.37]), between groups.Conclusion: 18-week treatment of liraglutide compared with glimepiride did not improve LFRIdiastolic/systolic, but however increased HR. There was a significant treatment change in body weight reduction in favor for liraglutide treatment.
19.	Nyström, Thomas, et al. (författare) Effects on Subclinical Heart Failure in Type 2 Diabetic Subjects on Liraglutide Treatment vs. Glimepiride Both in Combination with Metformin : A Randomized Open Parallel-Group Study (vol 8, 325, 2017) 2018 Ingår i: Frontiers in Endocrinology. - : Frontiers Media S.A.. - 1664-2392. ; 9 Tidskriftsartikel (refereegranskat)
20.	Sharif, Ali, et al. (författare) Compliance to Screening of Diabetic Retinopathy with 18 to 36 Months Interval 2018 Ingår i: European Journal of Ophthalmology. - : Sage Publications. - 1120-6721 .- 1724-6016. ; 28:Suppl. 1, s. 9-9 Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
21.	Sharif, Ali, 1986-, et al. (författare) Diabetic retinopathy among the elderly with type 2 diabetes : A Nationwide longitudinal registry study 2024 Ingår i: Acta Ophthalmologica. - : John Wiley & Sons. - 1755-375X .- 1755-3768. Tidskriftsartikel (refereegranskat)abstract Purpose: To investigate the prevalence, incidence and risk factors of DR in elderly people living with type 2 diabetes.Methods: Individuals >80 years, in the Swedish National Diabetes Register (NDR) between 2008 and 2017, were included. Prevalence and incidence were calculated and stratified by age. Estimates were assessed by longitudinal binary logistic regression models.Results: One hundred forty-one thousand, one hundred fifty-eight individuals with type 2 diabetes were included, median age 83 years, 53.3% females and with a median HbA1c 52 mmol/mol. The DR prevalence was stable at 336.2 cases/1000 patients in 2008 (95% CI, 330.2-342.3), with no significant changes during the 10-year period. Crude DR incidence rate: 88.5 cases/1000 patient years (95% CI, 87.6-89.4). The incidence rate was lower at higher ages. The effect of age on incident DR varied by sex, with females having an increasingly higher risk than males from 83 years of age, OR 1.25 (1.11-1.42) at age 90 years. The risk of incident DR with longer diabetes duration increased more rapidly at worse glycaemic control.Conclusion: The growing population of elderly with type 2 diabetes shows a stable proportion of DR and proposes an increased need for DR screening and eye care. Established risk factors for DR, such as diabetes duration and level of glycaemic control, are also important in the elderly; however, age and sex should be considered.
22.	Sharif, Ali, 1986-, et al. (författare) Inter-observer Reliability of Counting Retinal Microaneurysms and Haemorrhages in Elderly with Diabetes 2023 Ingår i: European Journal of Ophthalmology. - : Sage Publications. - 1120-6721 .- 1724-6016. ; 33:1 Suppl., s. 20-20 Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract DESIGN: Cross-sectional retrospective cohort study.PURPOSE: To investigate if quantifying retinal microvascular lesions is a reliable outcome measure in elderly.METHODS: Fundus photographs from all patients with type 2 diabetes, age ≥80 years, visiting the screening program 2008 in Region Värmland Sweden, n = 668, were reviewed. Inclusion criteria were mild/moderate diabetic retinopathy (DR) according to the International Diabetic Retinopathy Severity Scale. Exclusion criteria were hard exudates within two disc-diameters, and microaneurysms or haemorrhages within one-disc diameter, from the centre of the macula. Two observers counted microaneurysms and haemorrhages independently. Outcome measures were the total sum of microaneurysms and the total sum of haemorrhages per patient. Correlation, agreement and reliability between the counts of the observers was assessed. Analyses microaneurysm counts utilized all included patients while analyses of haemorrhages those with at least moderate DR in one eye.RESULTS: In total 101 patients met the inclusion/exclusion criteria, median age 82 years and 50.5% were of female sex. Moderate DR in at least one eye was present in 59 patients. In all patients the number of microaneurysms ranged from 1-82, and among patients with at least moderate DR the haemorrhages ranged from 1–29. For microaneurysm count the Pearson correlation coefficient was 0.896 p < 0.001 and intraclass correlation coefficient (ICC) was 0.944 (95% CI 0.917–0.962) between the two observers. For haemorrhage count the Pearson correlation coefficient was 0.897 p < 0.001 and ICC was 0.94 (95% CI: 0.893–0.965) between the two observers.CONCLUSIONS: Retinal microaneurysm count and haemorrhage count was assessed with excellent reliability. The results suggests that retinal microvascular lesions in elderly with diabetes can be manually quantified but the usefulness of such measures needs further evaluation.
23.	Sharif, Ali, 1986-, et al. (författare) Screening for Diabetic Retinopathy with Extended Intervals, Safe and Without Compromising Adherence : A Retrospective Cohort Study 2021 Ingår i: Diabetes Therapy. - : Springer. - 1869-6953 .- 1869-6961. ; 12:1, s. 223-234 Tidskriftsartikel (refereegranskat)abstract INTRODUCTION: Screening for diabetic retinopathy (DR) prevents blindness through the early detection of sight-threatening retinal microvascular lesions that respond to timely local treatment. However, the provision of easy and regular access to DR screening programs is currently being challenged by the increasing prevalence of diabetes. One proposed solution is to extend the screening interval for patients at low risk for progression of retinopathy. To date, most providers of screening programs have hesitated to implement a strategy of extended intervals due to the lack of data on whether adherence and safety are compromised when retinal examinations occur less frequently. In the study reported here, we investigated adherence to the screening program and progression of retinopathy in patients with type 2 diabetes participating in a DR screening program with extended intervals.METHODS: This was a retrospective study that included 1000 patients with type 2 diabetes mellitus who attended a screening program for DR. The patients were consecutively placed into a low-risk patient cohort with no retinopathy or into an intermediate-risk patient cohort with mild retinopathy (each cohort n = 500). Screening intervals were 36 months for the low-risk cohort and 18 months for the intermediate-risk cohort.RESULTS: The 1000 subjects enrolled in the study had a median age of 68 (interquartile range 12) years and 60.4% were men. At the follow-up screening visit, data on 102 subjects were not included in the analysis of adherence rate due to death, severe systemic illness, other concurrent eye disease or migration. Among the 898 remaining subjects, adherence to the screening program was 93.7% (413/443) in the 36-month group and 98.3% (449/455) in the 18-month group (p < 0.0001). Non-adherence decreased with increasing age (odds ratio 0.92, 95% confidence interval 0.888-0.954, p = 0.0005). At follow-up, 65 subjects showed progression of retinopathy; none had worse than moderate retinopathy. Risk factors for DR and treatment for hyperglycemia, hypertension and hyperlipidemia were compared among subjects in the low-risk cohort: non-adherent subjects did not differ from their adherent counterparts without progression of DR, but the former had a shorter duration of diabetes and higher diastolic blood pressure than adherent subjects with progression of DR (4.5 vs. 7.5 years, p = 0.007; and 80 vs. 75 mmHg, p = 0.02, respectively).CONCLUSION: The results suggest that screening DR at extended intervals can be achieved with high adherence rates without compromising patient safety. However, younger subjects and those at higher risk of progression may require extra attention.
24.	Adolfsson, Peter, et al. (författare) Automated Insulin Delivery Systems in Pediatric Type 1 Diabetes : A Narrative Review 2024 Ingår i: Journal of Diabetes Science and Technology. - : Diabetes Technology Society. - 1932-2968. Forskningsöversikt (refereegranskat)abstract This narrative review assesses the use of automated insulin delivery (AID) systems in managing persons with type 1 diabetes (PWD) in the pediatric population. It outlines current research, the differences between various AID systems currently on the market and the challenges faced, and discusses potential opportunities for further advancements within this field. Furthermore, the narrative review includes various expert opinions on how different AID systems can be used in the event of challenges with rapidly changing insulin requirements. These include examples, such as during illness with increased or decreased insulin requirements and during physical activity of different intensities or durations. Case descriptions give examples of scenarios with added user-initiated actions depending on the type of AID system used. The authors also discuss how another AID system could have been used in these situations.
25.	Adolfsson, Peter, et al. (författare) Education and individualized support regarding exercise and diabetes improves glucose control and level of physical activity in type 1 diabetes individuals 2015 Ingår i: Journal of Endocrinology Diabetes & Obesity. - : JSciMed Central. - 2333-6692. ; 3:2, s. 1071-1077 Tidskriftsartikel (refereegranskat)abstract Background: Physical activity is advocated in all individuals with diabetes. However, good glycemic control can be difficult to achieve due to exercise induced glucose excursions.Objective: To evaluate the impact on glucose control of a structured diabetes education concerning physical activity, delivered via the web/internet together with telemedical care (individualized feedback by phone).Methods: Eighty-two individuals with type 1 (T1D) were included in the pre-race intervention and randomized into two groups: intervention (I) (n=48) and control (C) (n=48). Both groups received web-based training of sports and nutrition in relation to diabetes. The intervention group also received structured and individualized feedback on two different occasions. HbA1c was measured at baseline, after 3 and 6 months when a 45 km cross-country skiing race (the HalvVasa) was performed. Only the individuals attending the skiing race were eligible to be included in the study. Level of Physical Activity (LPA), Multidimensional Health Locus of Control (MHLC) and Confidence In Diabetes Self-care (CIDS) were assessed at baseline and after 7 months.Results: HbA1c at start was 58.5 ± 10.0 (I) respectively 60.7 ± 9.5 (C) mmol/mol. At 3 months 56.7 ± 8.7 (I) respectively 61.0 ± 9.6 (C) mmol/mol and at 6 months 55.7 ± 8.1 (I) respectively 60.3 ± 9.7 (C) mmol/mol. A significant in (I) at 3 months: 2.2 ± 3.8 mmol/mol (0.7-3.7, 95% CI), (p<0.05) and after 6 months: 2.8 ± 5.5 mmol/mol (0.5-5.0, 95% CI), (p<0.05). No reduction was seen in (C). However between the two groups no difference was noted. The LPA was increased in 52% of the participants in (I) respectively 7% in (C), a significant difference, p<0.05. No differences were seen regarding HbA1c or LPA in the control group.Conclusion: Education and individualized feedback, delivered via telemedicine, to physical active individuals with T1D resulted in improvements in glycemic control within the intervention group and improved level of physical activity and locus of control when compared to the control group(12) (PDF) Education and individualized support regarding exercise and diabetes improves glucose control and level of physical activity in type 1 diabetes individuals.
26.	Andersson, Emelie, et al. (författare) Costs of diabetes complications : hospital-based care and absence from work for 392,200 people with type 2 diabetes and matched control participants in Sweden 2020 Ingår i: Diabetologia. - : Springer. - 0012-186X .- 1432-0428. ; 63:12, s. 2582-2594 Tidskriftsartikel (refereegranskat)abstract AIMS/HYPOTHESIS: The risk of complications and medical consequences of type 2 diabetes are well known. Hospital costs have been identified as a key driver of total costs in studies of the economic burden of type 2 diabetes. Less evidence has been generated on the impact of individual diabetic complications on the overall societal burden. The objective of this study was to analyse costs of hospital-based healthcare (inpatient and outpatient care) and work absence related to individual macrovascular and microvascular complications of type 2 diabetes in Sweden in 2016.METHODS: Data for 2016 were retrieved from a Swedish national retrospective observational database cross-linking individual-level data for 1997-2016. The database contained information from population-based health, social insurance and socioeconomic registers for 392,200 people with type 2 diabetes and matched control participants (5:1). Presence of type 2 diabetes and of diabetes complications were derived using all years, 1997-2016. Costs of hospital-based care and of absence from work due to diabetes complications were estimated for the year 2016. Regression analysis was used for comparison with control participants to attribute absence from work to individual complications, and to account for joint presence of complications.RESULTS: Use of hospital care for complications was higher in type 2 diabetes compared with control participants in 2016: 26% vs 12% had ≥1 hospital contact; there were 86,104 vs 24,608 outpatient visits per 100,000 people; and there were 9894 vs 2546 inpatient admissions per 100,000 people (all p < 0.001). The corresponding total costs of hospital-based care for complications were €919 vs €232 per person (p < 0.001), and 74.7% of costs were then directly attributed to diabetes (€687 per person). Regression analyses distributed the costs of days absent from work across diabetes complications per se, basic type 2 diabetes effect and unattributed causes. Diabetes complications amounted to €1317 per person in 2016, accounting for possible complex interactions (25% of total costs of days absent). Key drivers of costs were the macrovascular complications angina pectoris, heart failure and stroke; and the microvascular complications eye diseases, including retinopathy, kidney disease and neuropathy. Early mortality in working ages cost an additional €579 per person and medications used in risk-factor treatment amounted to €418 per person.CONCLUSIONS/INTERPRETATION: The economic burden of complications in type 2 diabetes is substantial. Costs of absence from work in this study were found to be greater than of hospital-based care, highlighting the need for considering treatment consequences in a societal perspective in research and policy. Graphical abstract.
27.	Benhalima, Katrien, et al. (författare) Automated Insulin Delivery for Pregnant Women With Type 1 Diabetes : Where do we stand? 2024 Ingår i: Journal of Diabetes Science and Technology. - : Diabetes Technology Society. - 1932-2968. Tidskriftsartikel (refereegranskat)abstract Automated insulin delivery (AID) systems mimic an artificial pancreas via a predictive algorithm integrated with continuous glucose monitoring (CGM) and an insulin pump, thereby providing AID. Outside of pregnancy, AID has led to a paradigm shift in the management of people with type 1 diabetes (T1D), leading to improvements in glycemic control with lower risk for hypoglycemia and improved quality of life. As the use of AID in clinical practice is increasing, the number of women of reproductive age becoming pregnant while using AID is also expected to increase. The requirement for lower glucose targets than outside of pregnancy and for frequent adjustments of insulin doses during pregnancy may impact the effectiveness and safety of AID when using algorithms for non-pregnant populations with T1D. Currently, the CamAPS® FX is the only AID approved for use in pregnancy. A recent randomized controlled trial (RCT) with CamAPS® FX demonstrated a 10% increase in time in range in a pregnant population with T1D and a baseline glycated hemoglobin (HbA1c) ≥ 48 mmol/mol (6.5%). Off-label use of AID not approved for pregnancy are currently also being evaluated in ongoing RCTs. More evidence is needed on the impact of AID on maternal and neonatal outcomes. We review the current evidence on the use of AID in pregnancy and provide an overview of the completed and ongoing RCTs evaluating AID in pregnancy. In addition, we discuss the advantages and challenges of the use of current AID in pregnancy and future directions for research.
28.	Blonde, Lawrence, et al. (författare) Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4) : a randomised, open-label, phase 3, non-inferiority study 2015 Ingår i: The Lancet. - New York, USA : Elsevier. - 0140-6736 .- 1474-547X. ; 385:9982, s. 2057-2066 Tidskriftsartikel (refereegranskat)abstract Background: For patients with type 2 diabetes who do not achieve target glycaemic control with conventional insulin treatment, advancing to a basal-bolus insulin regimen is often recommended. We aimed to compare the efficacy and safety of long-acting glucagon-like peptide-1 receptor agonist dulaglutide with that of insulin glargine, both combined with prandial insulin lispro, in patients with type 2 diabetes.Methods: We did this 52 week, randomised, open-label, phase 3, non-inferiority trial at 105 study sites in 15 countries. Patients (aged ≥18 years) with type 2 diabetes inadequately controlled with conventional insulin treatment were randomly assigned (1:1:1), via a computer-generated randomisation sequence with an interactive voice-response system, to receive once-weekly dulaglutide 1·5 mg, dulaglutide 0·75 mg, or daily bedtime glargine. Randomisation was stratified by country and metformin use. Participants and study investigators were not masked to treatment allocation, but were unaware of dulaglutide dose assignment. The primary outcome was a change in glycated haemoglobin A1c (HbA1c) from baseline to week 26, with a 0·4% non-inferiority margin. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01191268.Findings: Between Dec 9, 2010, and Sept 21, 2012, we randomly assigned 884 patients to receive dulaglutide 1·5 mg (n=295), dulaglutide 0·75 mg (n=293), or glargine (n=296). At 26 weeks, the adjusted mean change in HbA1c was greater in patients receiving dulaglutide 1·5 mg (-1·64% [95% CI -1·78 to -1·50], -17·93 mmol/mol [-19·44 to -16·42]) and dulaglutide 0·75 mg (-1·59% [-1·73 to -1·45], -17·38 mmol/mol [-18·89 to -15·87]) than in those receiving glargine (-1·41% [-1·55 to -1·27], -15·41 mmol/mol [-16·92 to -13·90]). The adjusted mean difference versus glargine was -0·22% (95% CI -0·38 to -0·07, -2·40 mmol/mol [-4·15 to -0·77]; p=0·005) for dulaglutide 1·5 mg and -0·17% (-0·33 to -0·02, -1·86 mmol/mol [-3·61 to -0·22]; p=0·015) for dulaglutide 0·75 mg. Five (<1%) patients died after randomisation because of septicaemia (n=1 in the dulaglutide 1·5 mg group); pneumonia (n=1 in the dulaglutide 0·75 mg group); cardiogenic shock; ventricular fibrillation; and an unknown cause (n=3 in the glargine group). We recorded serious adverse events in 27 (9%) patients in the dulaglutide 1·5 mg group, 44 (15%) patients in the dulaglutide 0·75 mg group, and 54 (18%) patients in the glargine group. The most frequent adverse events, arising more often with dulaglutide than glargine, were nausea, diarrhoea, and vomiting.Iinterpretation: Dulaglutide in combination with lispro resulted in a significantly greater improvement in glycaemic control than did glargine and represents a new treatment option for patients unable to achieve glycaemic targets with conventional insulin treatment.FUNDING: Eli Lilly and Company.
29.	Brunner, G. A., et al. (författare) Dose-response relation of liquid aerosol inhaled insulin in type I diabetic patients. 2001 Ingår i: Diabetologia. - : Springer. - 0012-186X .- 1432-0428. ; 44:3, s. 305-308 Tidskriftsartikel (refereegranskat)abstract AIMS/HYPOTHESIS: The AERx insulin Diabetes Management system (AERx iDMS) is a liquid aerosol device that enables insulin to be administered to the peripheral parts of the lung. This study aimed to compare the pharmacokinetic and pharmacodynamic properties of insulin which is inhaled using AERx iDMS with insulin which is subcutaneously administered.METHODS: In total, 18 C-peptide negative patients with Type I (insulin-dependent) diabetes mellitus participated in this randomised, open-label, 5-period crossover trial. Human regular insulin was administered subcutaneously (0.12 U/kg body weight) or inhaled by means of the AERx iDMS (dosages 0.3, 0.6, 1.2, and 1.8 U/kg body weight). Thereafter plasma glucose was kept constant at 7.2 mmol/l for a 10-h period (glucose clamp technique).RESULTS: Inhaled insulin provided a dose-response relation that was close to linear for both pharmacokinetic (AUC-Ins(0-10 h); Cmax-Ins) and pharmacodynamic (AUC-GIR(0-10 h); GIRmax) parameters. Time to maximum insulin concentration (Tmax-Ins) and time to maximum glucose infusion rate (TGIRmax) were shorter with inhaled insulin than with subcutaneous administration. The pharmacodynamic system efficiency of inhaled insulin (AUC-GIR(0-6 h) was 12.7% (95% C.I.: 10.2-15.6).CONCLUSION/INTERPRETATION: The inhalation of soluble human insulin using the AERx iDMS is feasible and provides a clear dose response. Further long-term studies are required to investigate safety aspects, HbA1c values, incidence of hypoglycaemic events and the quality of life.
30.	Carlsson, K. Steen, et al. (författare) Costs of diabetes complications : hospital based care and production loss for 392,200 people with type 2 diabetes and matched controls in Sweden 2020 Ingår i: Diabetologia. - : Springer. - 0012-186X .- 1432-0428. ; 63:Suppl. 1, s. S121-S121 Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract Background and aims: The prevalence of diabetes has increased rapidly over the last decades worldwide. The risk of complications and medical consequences is well known and identified as key driver of costs. Less evidence on the impact of individual diabetic complications on the societal burden is available. The objective was to analyse costs of hospital-based health care and work absence related to individual macrovascular and microvascular complications of type 2 diabetes in Sweden in 2016.Materials and methods: The study used data from a Swedish retrospective observational database cross-linking 20 years of individual-level data (1997-2016) from national population-based health, social insurance and socio-economic registers for 392,200 people with type 2 diabetes and matched controls (5:1). Diabetes status and presence of 19 types of complications were derived from years 1997-2016 while the costs of hospital-based care and of production loss due to diabetes complications were estimated for 2016. Regression analysis was used for comparison to controls, to attribute production loss to individual complications, and to account for joint presence of complications.Results: Complications are prevalent and patterns complex in type 2 diabetes (Fig. 1). Use of hospital care for complications was higher compared to controls: 86,104 vs 24,608 outpatient visits per 100,000 persons and 9,894 vs 2,546 inpatient admissions per 100,000 persons (p<0.001) in 2016. 26% vs 12% had ≥1 hospital contact. The corresponding total costs of hospital-based care fo rcomplications were EUR 91,875 vs EUR 23,222 per 100 persons (p<0.001) and 75% were directly attributed to diabetes (EUR 689/person). Regression analyses distributed the costs of days absent from work across diabetes complications, basic type 2 diabetes effect and unattributed causes: diabetes complications amounted to EUR 2,165/person in 2016. Key drivers of costs of production loss were macrovascular complications angina pectoris, heart failure and stroke, and microvascular complications eye disease including retinopathy, kidney disease and neuropathy. Early mortality in working ages cost additional EUR 579/person and medications used in risk-factor treatment amounted to EUR 418/person.Conclusion: The economic burden of complications in type 2 diabetes is substantial. Costs of productivity loss in this study were found to be greater than those of hospital-based care highlighting the need for considering treatment consequences in a societal perspective in research and policy.
31.	Catrina, S., et al. (författare) Type 1 diabetes : analysis of real-world insulin injection patterns 2020 Ingår i: Diabetologia. - : Springer. - 0012-186X .- 1432-0428. ; 63:Suppl. 1, s. S378-S378 Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract Background and aims: Multiple daily insulin injections are an integral part of life for patients with type 1 diabetes (T1D). Moreover, patients’ schedules can change from day-to-day, further complicating T1D management. This study aimed to analyze daily injection patterns for patients with T1D, thereby providing insights into patients’ behaviour.Materials and methods: This post hoc observational study included children and adults with T1D from Sweden using NovoPen®6with bolus insulin (primarily insulin aspart) and/or basal insulin (primarily insulin degludec). Injection data were uploaded via the Glooko® cloud system. Daily bolus and basal injection timing profiles were documented, weighting each dose relative to the total daily dose. The time difference between two consecutive basal insulin injections was used to evaluate basal timing variation.Results: Overall, 159 adults and 47 children were included in the analysis, with a total of 38678 days of bolus injections and 17869 days of basal injections. The mean bolus daily injection profile displayed peaks at typical mealtimes, but substantial variation was observed both across patients and between adults and children (Figure 1). In those receiving insulin degludec, the timing of consecutive basal injections differed by more than 6 hr in approximately 9% of the injections for adults and 7% of those for children.Conclusion: These real-world data provide a unique insight into the everyday bolus and basal adherence of paediatric and adult patients with T1D. Furthermore, the results illustrate the flexibility needed for basal injections to enable optimal management of T1D.
32.	Coaquira, Castro J., et al. (författare) INTERNAL, EXTERNAL, AND CROSS-VALIDATION OF THE DEDUCE MODEL, A COST-UTILITY TOOL USING PATIENT-LEVEL MICROSIMULATION TO EVALUATE SENSOR-BASED GLUCOSE MONITORING SYSTEMS IN TYPE 1 AND TYPE 2 DIABETES 2022 Ingår i: Value in Health. - : ELSEVIER SCIENCE INC. - 1098-3015 .- 1524-4733. ; 25:12 Suppl., s. S11-S11 Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract Objectives: For health care decision-makers, the use of computer simulation modelsr equires transparency, precision and accuracy. Systematic comparisons of diabetes models, per Mount Hood Challenges, have shown significant variability in results between models. We developed and validated a new cost-effectiveness model (the DEtermination of Diabetes Utilities, Costs, and Effects [DEDUCE] model) in both type 1 and 2 diabetes mellitus (T1DM, T2DM) to evaluate sensor-based glucose monitoring.Methods: This Excel-based patient-level microsimulation model used a cost-utility approach to compare sensor-based glucose monitoring systems to self-monitoring of blood glucose (SMBG) testing over a specified time horizon (1 to 100 years) with yearly cycles. The model used the Sheffield risk engine for T1DM and the Risk Equations for Complications Of type 2 Diabetes (RECODe) risk engine for T2DM to predict macro- and microvascular events. Inputs, model architecture, and subse-quent validation analyses were reviewed and informed by an advisory board of health economists, endocrinologists and diabetologists.Results: Internal validation (comparing model predictions to observed outcomes from studies from which the risk equations were derived) and external validation (predictions compared to external datasets) demonstrated high precision (R2 $ 0.98) and reasonable accuracy (mean absolute percentage error [MAPE] ranging from 7.64-68%) with regards to macrovascular outcomes for T1DM, and high precision (R2 = 0.94) and high accuracy (MAPE = 19.8%) with regards to all-cause mortality in T2DM. Cross validation (comparing model outcomes between DEDUCE and published results from models participating in previous Mount Hood Challenges) indicated that DEDUCE had the best accuracy (MAPE = 36%) and non-inferior precision (R2 = 0.16) relative to other T1DM models, and second-to-best accuracy (MAPE = 25.03%) and high precision (R2 = 0.95) relative to other T2DM models.Conclusions: In both T1DM & T2DM, DEDUCE suitably predicted key outcomes and performed favorably compared with existing models that participated in the Mount Hood Challenges, including the Core Diabetes Model.
33.	Cohen, O., et al. (författare) COST-EFFECTIVENESS ANALYSIS OF THE MINIMED (TM) 780G SYSTEM VERSUS MULTIPLE DAILY INJECTIONS WITH INTERMITTENTLY SCANNED CONTINUOUS GLUCOSE MONITORING IN INDIVIDUALS WITH TYPE 1 DIABETES IN SWEDEN 2021 Ingår i: Diabetes Technology & Therapeutics. - : Mary Ann Liebert. - 1520-9156 .- 1557-8593. ; 23:Suppl. 2, s. A81-A81 Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract Background and Aims: Type 1 diabetes (T1D) therapy is continually evolving and Advanced Hybrid Closed Loop (AHCL) insulin pump systems and intermittently scanned continuous glucose monitoring (IS‐CGM) are emerging as the standard of care for many individuals with T1D. The objective of this analysis was to assess the cost‐effectiveness of the MiniMedTM 780G AHCL system versus IS‐CGM plus multiple daily injections of insulin (MDI) or continuous subcutaneous insulin infusion (CSII) in adults with T1D in Sweden.Methods: The analysis was performed using the IQVIA CORE Diabetes Model and clinical input data were sourced from observational studies. Simulated patients were assumed to have a baseline HbA1c of 7.8% (62 mmol/mol)[1] and use of the MiniMed™ 780G system was assumed to reduce HbA1c by 0.5%.[2] The analysis was performed from a societal perspective over a lifetime time horizon. Future costs and clinical outcomes were discounted at 3% per annum.Results: The MiniMedTM 780G system was associated with a quality‐adjusted life‐year (QALY) gain of 1.946 but generated higher overall costs versus MDI/CSII+IS‐CGM, leading to an incremental cost‐effectiveness ratio of SEK 373,700 (€ 36,857.80) per QALY‐gained. MiniMedTM 780G system use resulted in a lower cumulative incidence of diabetes‐related complications. Higher acquisition costs were partially offset by reduced complications costs. Extensive sensitivity analysis on key drivers confirmed the robustness of results.Conclusions: For the lifetime of adults with long‐standing T1D based in Sweden, use of the MiniMed™ 780G system is projected to be cost‐effective when compared with IS‐CGM plus MDI/CSII.
34.	Da Silva, Julien, et al. (författare) Real-world performance of the MiniMed™ 670G system in Europe 2021 Ingår i: Diabetes, obesity and metabolism. - : Wiley-Blackwell Publishing Inc.. - 1462-8902 .- 1463-1326. ; 23:8, s. 1942-1949 Tidskriftsartikel (refereegranskat)abstract AIMS: The MiniMed™ 670G system has been available in Europe since October 2018. Herein, the system's real-world performance in individuals with diabetes is evaluated.MATERIALS AND METHODS: Data uploaded October 2018 to July 2020 by individuals living in Europe were aggregated and retrospectively analyzed. The mean Glucose Management Indicator (GMI), percentage of time spent within (TIR), below (TBR) and above (TAR) glycemic ranges, system use and insulin consumed in users with ≥10 days of SG data after initial Auto Mode start were determined. Another analysis based on suboptimally- (GMI >8.0%) and well-controlled (GMI <7.0%) glycemia pre-Auto Mode initiation was also performed.RESULTS: Users (N=14,899) spent a mean of 81.4% of the time in Auto Mode and achieved a mean GMI of 7.0±0.4%, TIR of 72.0±9.7%, TBR <3.9 mmol/L of 2.4±2.1% and TAR >10 mmol/L of 25.7±10%, after initiating Auto Mode. When compared to pre-Auto Mode initiation, GMI reduced by 0.3±0.4% and TIR increased by 9.6±9.9% (p<0.0001 for both). Significantly improved glycemic control was observed irrespectively of pre-Auto Mode GMI level <7.0% or >8.0%. While total daily dose of insulin increased for both groups, a greater increase was observed in the latter: an increase due primarily to increased basal insulin delivery. In contrast, basal insulin decreased slightly in well-controlled users.CONCLUSIONS: Most MiniMed™ 670G system users in Europe achieved TIR >70% and GMI <7% while minimizing hypoglycemia, in a real-world environment. These international consensus-met outcomes were enabled by automated insulin delivery meeting real-time insulin requirements adapted to each individual user.
35.	de Valk, Harold W., et al. (författare) Switching to Degludec is Associated with Reduced Hypoglycaemia, Irrespective of Definition Used or Patient Characteristics : Secondary Analysis of the ReFLeCT Prospective, Observational Study 2020 Ingår i: Diabetes Therapy. - : Springer. - 1869-6953 .- 1869-6961. ; 11:9, s. 2159-2167 Tidskriftsartikel (refereegranskat)abstract Introduction: Hypoglycaemia is a common side effect of insulin therapy; low or high glycated haemoglobin (HbA(1c)) levels, history of hypoglycaemia or long diabetes duration are known modifiers of hypoglycaemia risk. In randomised clinical trials, lower rates of hypoglycaemia have been observed with the new-generation insulin analogue, long-acting insulin degludec, compared with other basal insulins.Methods: The ReFLeCT study was a prospective observational study over 12 months. Patient-reported diary data on hypoglycaemia were collected from patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) who were switching from other basal insulins to insulin degludec (degludec) at their physician's discretion in routine clinical care. Two secondary analyses were undertaken to investigate the change in number of hypoglycaemic events: a post hoc analysis using the updated American Diabetes Association (ADA) level 1, 2 and 3 hypoglycaemia definitions, and a pre-specified analysis using patient characteristics (baseline HbA(1c), diabetes duration, and physician's rationale for initiating degludec).Results: Switching to degludec was associated with significantly fewer hypoglycaemic events for all definitions in T1D, and level 1 and 2 in T2D (too few level 3 events for statistical comparison). Moreover, patient characteristics did not influence the observed reduction in hypoglycaemia in T1D and T2D.Conclusion: These results demonstrate that switching to degludec from other basal insulins was associated with reduced rates of hypoglycaemia, irrespective of the definition used or baseline patient characteristics.Plain Language Summary: Low blood sugar levels (hypoglycaemia) are a common, and sometimes serious, side effect of treatment with insulin in people with diabetes. In the ReFleCT study, adults with type 1 (T1D) and type 2 diabetes (T2D) were asked to complete a diary for 12 months when their doctor changed their previous long-acting insulin treatment to insulin degludec (degludec). The key outcome of the study was whether the frequency of hypoglycaemia changed when a patient's insulin treatment was switched. Here, we used the diary information from the ReFLeCT study to investigate whether the change in the rate of hypoglycaemia was related to the way hypoglycaemia was defined, or to patients' characteristics at the time their insulin was switched. These characteristics included the length of time that patients had had diabetes, their blood sugar control, and their doctor's reason for changing their medication. Our findings showed that the way hypoglycaemia was defined, and patients' characteristics, did not generally influence the frequency of hypoglycaemia for patients with T1D or T2D. However, the most severe hypoglycaemia in patients with T2D occurred too infrequently to be assessed. Patients in all groups had less hypoglycaemia overall after switching compared with their previous treatment, suggesting that degludec may be a treatment option for a broad range of patients with diabetes.
36.	de Valk, H.W., et al. (författare) Switching to insulin degludec from other basal insulins reduces rates of hypoglycaemia across patient subgroups in routine clinical care : The ReFLeCT study 2019 Konferensbidrag (övrigt vetenskapligt/konstnärligt)
37.	de Valk, H.W., et al. (författare) Switching to insulin degludec from other basal insulins reduces rates of hypoglycemia (according to different definitions) in routine clinical care : The ReFLeCT Study 2019 Konferensbidrag (övrigt vetenskapligt/konstnärligt)
38.	de Valk, H.W., et al. (författare) Switching to insulin degludec from other basal insulins reduces rates of hypoglycemia across patient subgroups in routine clinical care : The ReFleCT study 2019 Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract ReFLeCT, a multicenter, prospective, observational study evaluated the safety and effectiveness of switching from other basal insulins to insulin degludec (degludec) in patients with type 1 (T1D) or type 2 diabetes (T2D) in routine clinical practice. ReFLeCT comprised a 4-week baseline period (pre-switch basal insulin) and 12-month follow-up period (degludec). The primary endpoint of overall hypoglycemia reported in patient diaries was reduced during the 12-month follow-up period vs. baseline, without compromising glycemic control. In pre-specified subgroup analyses of the primary endpoint, we assessed if the overall result was robust in different subgroups, characterized according to baseline A1C (<7.5, ≥7.5-<8.5, ≥8.5-<9.5, ≥9.5%), diabetes duration (quartiles) and physician’s reason for initiating degludec (hypoglycemia [Yes/No]). The estimated rate ratios of hypoglycemia were similar within subgroups (no significant interactions), and demonstrated overall lower rates (the majority significantly lower) during the 12-month follow-up periods vs. baseline in patients with T1D or T2D (Figure). Irrespective of baseline characteristics or physician’s reason for initiating degludec, switching to degludec from other basal insulins reduced rates of overall hypoglycemia in patients with T1D or T2D, in routine clinical practice.
39.	Dobrosavljevic, Maja, 1986-, et al. (författare) Risk prediction model for cardiovascular diseases in adults initiating pharmacological treatment for attention-deficit/hyperactivity disorder 2022 Ingår i: Evidence-Based Mental Health. - : BMJ Publishing Group Ltd. - 1362-0347 .- 1468-960X. ; 25, s. 185-190 Tidskriftsartikel (refereegranskat)abstract Background: Available prediction models ofcardiovascular diseases (CVDs) may not accuratelypredict outcomes among individuals initiatingpharmacological treatment for attention-deficit/hyperactivity disorder (ADHD).Objective: To improve the predictive accuracyof traditional CVD risk factors for adults initiatingpharmacological treatment of ADHD, by consideringnovel CVD risk factors associated with ADHD (comorbidpsychiatric disorders, sociodemographic factors andpsychotropic medication).Methods: The cohort composed of 24 186 adultsresiding in Sweden without previous CVDs, born between1932 and 1990, who started pharmacological treatmentof ADHD between 2008 and 2011, and were followedfor up to 2 years. CVDs were identified using diagnosesaccording to the International Classification of Diseases,and dispended medication prescriptions from Swedishnational registers. Cox proportional hazards regressionwas employed to derive the prediction model.Findings: The developed model included eighttraditional and four novel CVD risk factors. Themodel showed acceptable overall discrimination (Cindex=0.72, 95% CI 0.70 to 0.74) and calibration(Brier score=0.008). The Integrated DiscriminationImprovement index showed a significant improvementafter adding novel risk factors (0.003 (95% CI 0.001 to0.007), p<0.001).Conclusions: The inclusion of the novel CVD riskfactors may provide a better prediction of CVDs in thispopulation compared with traditional CVD predictorsonly, when the model is used with a continuous riskscore. External validation studies and studies assessingclinical impact of the model are warranted.Clinical implications: Individuals initiatingpharmacological treatment of ADHD at higher risk ofdeveloping CVDs should be more closely monitored.
40.	Eichenlaub, Manuel, et al. (författare) Comparator Data Characteristics and Testing Procedures for the Clinical Performance Evaluation of Continuous Glucose Monitoring Systems 2024 Ingår i: Diabetes Technology & Therapeutics. - : Mary Ann Liebert. - 1520-9156 .- 1557-8593. ; 26:4, s. 263-275 Tidskriftsartikel (refereegranskat)abstract Comparing the performance of different continuous glucose monitoring (CGM) systems is challenging due to the lack of comprehensive guidelines for clinical study design. In particular, the absence of concise requirements for the distribution of comparator (reference) blood glucose (BG) concentrations and their rate of change (RoC), that are used to evaluate CGM performance, impairs comparability. For this article, several experts in the field of CGM performance testing have collaborated to propose characteristics of the distribution of comparator measurements that should be collected during CGM performance testing. Specifically, it is proposed that at least 7.5% of comparator BG concentrations are <70 mg/dL (3.9 mmol/L) and >300 mg/dL (16.7 mmol/L), respectively and that at least 7.5% of BG-RoC combinations indicate fast BG changes with impending hypo- or hyperglycemia, respectively. These proposed characteristics of the comparator data can facilitate the harmonization of testing conditions across different studies and CGM systems and ensure that the most relevant scenarios representing real-life situations are established during performance testing. In addition, a study protocol and testing procedure for the manipulation of glucose levels is suggested that enables the collection of comparator data with these characteristics. This work is an important step towards establishing a future standard for the performance evaluation of CGM systems.
41.	Eichenlaub, Manuel, et al. (författare) Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA) : A Novel Approach for the Statistical Accuracy Assessment of Continuous Glucose Monitoring Systems 2022 Ingår i: Journal of Diabetes Science and Technology. - : Diabetes Technology Society. - 1932-2968. Tidskriftsartikel (refereegranskat)abstract BACKGROUND: The accuracy of continuous glucose monitoring (CGM) systems is crucial for the management of glucose levels in individuals with diabetes mellitus. However, the discussion of CGM accuracy is challenged by an abundance of parameters and assessment methods. The aim of this article is to introduce the Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA), a new approach for a comprehensive characterization of CGM point accuracy which is based on the U.S. Food and Drug Administration requirements for "integrated" CGM systems.METHODS: The statistical concept of tolerance intervals and data from two approved CGM systems was used to illustrate the CG-DIVA.RESULTS: The CG-DIVA characterizes the expected range of deviations of the CGM system from a comparison method in different glucose concentration ranges and the variability of accuracy within and between sensors. The results of the CG-DIVA are visualized in an intuitive and straightforward graphical presentation. Compared with conventional accuracy characterizations, the CG-DIVA infers the expected accuracy of a CGM system and highlights important differences between CGM systems. Furthermore, it provides information on the incidence of large errors which are of particular clinical relevance. A software implementation of the CG-DIVA is freely available (https://github.com/IfDTUlm/CGM_Performance_Assessment).CONCLUSIONS: We argue that the CG-DIVA can simplify the discussion and comparison of CGM accuracy and could replace the high number of conventional approaches. Future adaptations of the approach could thus become a putative standard for the accuracy characterization of CGM systems and serve as the basis for the definition of future CGM performance requirements.
42.	Evans, M., et al. (författare) Quantifying The Short-Term Impact of Changes In Hba1c, Weight And Insulin Regimen on Health Related Quality-of-Life 2015 Ingår i: Value in Health. - : Elsevier. - 1098-3015 .- 1524-4733. ; 18:7, s. A616-A616 Tidskriftsartikel (refereegranskat)
43.	Fadini, G. P., et al. (författare) Reduced rates of overall hypoglycaemia in patients with Type 1 diabetes after switching to insulin degludec : A European, multinational, multicentre, prospective, observational study (ReFLeCT) 2019 Ingår i: Diabetic Medicine. - : John Wiley & Sons. - 0742-3071 .- 1464-5491. ; 36:Suppl. 1, s. 60-60 Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract Aims: To evaluate the safety and effectiveness of switching to once‐daily insulin degludec (degludec) from other basal insulins in patients with Type 1 diabetes in routine clinical practice.Methods: ReFLeCT was a multicentre, prospective, observational study in seven European countries in patients (≥18 years) with Type 1 or Type 2 diabetes, whose physician planned to switch their basal insulin to degludec (ClinicalTrials.gov: NCT02392117). ReFLeCT comprised a four week baseline period (pre‐switch basal insulin) and a 12 month follow‐up period (degludec). For the Type 1 diabetes cohort presented here, primary endpoint was changed from baseline in the rate of overall hypoglycaemia recorded in patient diaries.Results: Baseline characteristics (mean [SD]) for patients with Type 1 diabetes (n = 556) were: age 47.4 (15.7) years, diabetes duration 21.4 (13.5) years, HbA1c 8.1 (1.3)% (65.0 [14.2]mmol/mol), fasting plasma glucose (FPG) 8.8 (3.9)mmol/l, pre‐switch basal insulin dose 25.0 (14.1)u/day, body mass index (BMI) 26.1 (4.7)kg/m2 and body weight 76.4 (15.6)kg. Estimated rate ratios of overall (0.80 [0.74; 0.88]95%CI), non‐severe (0.81 [0.74; 0.88]95%CI), severe (American Diabetes Association definition; 0.28 [0.14; 0.56]95%CI) and nocturnal (00:01−05:59am; 0.61 [0.50; 0.73]95%CI) hypoglycaemia illustrated significantly lower rates during 12 month follow‐up vs baseline. HbA1c, FPG and basal insulin dose decreased significantly by –0.15% [–0.23; –0.07]95%CI (–1.64mmol/mol [–2.51; –0.77]95%CI), –0.54mmol/l [–0.95; –0.14]95%CI and –2.21u/day [–2.90; –1.53]95%CI, respectively, and body weight was 0.79kg [0.38; 1.20]95%CI higher, at 12 month follow‐up vs baseline.Conclusion: Switching from other basal insulins to degludec significantly reduced the rates of hypoglycaemia and improved glycaemic control at lower basal insulin doses in patients with Type 1 diabetes in routine clinical practice.
44.	Fadini, Gian Paolo, et al. (författare) Switching to Degludec from Other Basal Insulins is Associated with Reduced Hypoglycemia Rates : a Prospective Study 2019 Ingår i: Journal of Clinical Endocrinology and Metabolism. - : Oxford University Press. - 0021-972X .- 1945-7197. ; 104:12, s. 5977-5990 Tidskriftsartikel (refereegranskat)abstract CONTEXT: Observational studies of insulin degludec (degludec) with hypoglycemia events prospectively recorded are lacking.OBJECTIVE: To evaluate the safety and effectiveness of degludec in patients with type 1 (T1D) or type 2 diabetes (T2D) switching from other basal insulins in routine care.DESIGN: ReFLeCT was a multinational, multicenter, prospective, observational, single-arm study comprising a 4-week baseline period (pre-switch basal insulin) and 12-month follow-up (degludec).SETTING: Routine clinical practice. Patients or Other Participants: Insulin-treated patients (≥18 years) with T1D (n=556) or T2D (n=611) with treatment plans to initiate degludec.INTERVENTIONS: Switching to degludec from other basal insulins.MAIN OUTCOME MEASURE(S): Change from baseline in number of overall hypoglycemic events recorded in patient diaries.RESULTS: In T1D, the 12-month follow-up/baseline rate ratios [95% CI] of overall (0.80 [0.74;0.88]), non-severe (0.83 [0.76;0.91]), severe (0.28 [0.14;0.56]) and nocturnal (0.61 [0.50;0.73]) hypoglycemia suggested significantly reduced hypoglycemia rates with degludec (all P<0.001). At 12 months, HbA1c, fasting plasma glucose (FPG) and basal insulin dose decreased significantly. Body weight increased and treatment satisfaction improved significantly. In T2D, the hypoglycemia rate ratios were: overall (0.46 [0.38;0.56]), non-severe (0.53 [0.44;0.64]) and nocturnal (0.35 [0.20;0.62]) (all P<0.001; too few events for analysis of severe). At 12 months, HbA1c and FPG decreased significantly. Body weight and insulin doses remained unchanged, and treatment satisfaction was significantly improved.CONCLUSIONS: In a routine clinical care setting, switching to degludec from other basal insulins was associated with significantly reduced rates of hypoglycemia, improved glycemic control, and treatment satisfaction in patients with T1D or T2D.
45.	Faerch, Mia, et al. (författare) Skewed X-chromosome inactivation causing diagnostic misinterpretation in congenital nephrogenic diabetes insipidus 2010 Ingår i: Scandinavian Journal of Urology and Nephrology. - : Taylor & Francis. - 0036-5599 .- 1651-2065. ; 44:5, s. 324-330 Tidskriftsartikel (refereegranskat)abstract OBJECTIVE: To establish the clinical phenotype and genetic background in a family with diabetes insipidus.MATERIAL AND METHODS: The subjects were a sister and brother, aged 34 and 27 years, respectively, with a history of polyuria since infancy. Clinical testing confirmed a diagnosis of congenital nephrogenic diabetes insipidus (CNDI) in both. Samples of purified genomic DNA were analysed.RESULTS: The sequence of the entire coding region of the AQP2 gene as well as the AVPR2 gene was determined. Sequence analysis revealed no variations in the AQP2 gene. A missense variation in exon 2 of the AVPR2 gene (g.685G>A), predicting a p.Asp85Asn substitution, was identified in the X-chromosome of the affected male and one allele in the sister and the asymptomatic mother. The p.Asp85Asn variation in AVPR2 is known to cause CNDI, and has previously been described as inducing a partial phenotype treatable with dDAVP. However, in this family dDAVP had no influence on urine osmolality, whereas combination therapy with indomethacin and hydrochlorothiazide increased urine osmolality to 299 mosm/l in the proband. A skewed X-inactivation pattern (93%) occurring in the normal X allele was recognized in the sister.CONCLUSIONS: This study demonstrates the effect of skewed X-chromosome inactivation associated with X-linked CNDI. Polydipsia in early childhood could be due to X-linked CNDI despite affecting both genders. The significant heterogeneity in the clinical phenotype in CNDI carries a risk of diagnostic misinterpretation and emphasizes the need for genetic characterization. Treatment combining indomethacin and hydrochlorothiazide results in a marked response on both urine output and urine osmolality.
46.	Feher, M., et al. (författare) Hypoglycaemia, irrespective of the definition used, is reduced when switching to insulin degludec from other basal insulins in routine clinical care : The ReFLeCT study 2019 Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract Background and aims: ReFLeCT was a multicentre, prospective, observational study designed to investigate the safety and effectiveness of switching to insulin degludec (degludec) from other basal insulins in patients with type 1 (T1D) or type 2 diabetes (T2D). Few studies had prospectively collected hypoglycaemia data from patient diaries following a switch to degludec in everyday clinical practice. These additional analyses from the ReFLeCT study aimed to assess the effects of switching to degludec according to different hypoglycaemia definitions.Materials and methods: ReFLeCT comprised a 4-week baseline period (pre-switch basal insulin) and a 12-month follow-up period (degludec treatment). The primary endpoint of overall hypoglycaemia reported in patient diaries was reduced during follow-up vs baseline in T1D and T2D with improvement of glycaemic control, as previously reported. Here, hypoglycaemia data from ReFLeCT were analysed using pre-specified and updated (post hoc) American Diabetes Association (ADA) hypoglycaemia definitions. Definitions consisted of: documented asymptomatic and symptomatic, pseudo, probable symptomatic, and Level 1, 2 and 3 (severe) hypoglycaemia (Fig). Hypoglycaemic events were analysed using fully adjusted, negative binomial regression models.Results: In T1D (n=556) and T2D (n=611), estimated rate ratios across the previous and the updated ADA hypoglycaemia definitions were significantly lower during the 12-month follow-up vs the baseline period, except for asymptomatic hypoglycaemia in T1D and Level 3 hypoglycaemia in T2D (due to a low number of severe hypoglycaemic events, no comparable statistics were performed) (Fig). Event rates per patient year were also lower for all definitions during the 12-month follow-up vs the baseline period, except for Level 3 hypoglycaemia in T2D, which marginally increased, although this was likely due to the low number of events in this group.Conclusion: In patients with T1D and T2D, switching to degludec from other basal insulins in routine clinical care is associated with lower rates of hypoglycaemia across a broad range of hypoglycaemia definitions, in combination with improved glycaemic control.
47.	Freckmann, Guido, et al. (författare) Clinical Performance Evaluation of Continuous Glucose Monitoring Systems : A Scoping Review and Recommendations for Reporting 2023 Ingår i: Journal of Diabetes Science and Technology. - : Sage Publications. - 1932-2968. ; 17:6, s. 1506-1526 Forskningsöversikt (refereegranskat)abstract The use of different approaches for design and results presentation of studies for the clinical performance evaluation of continuous glucose monitoring (CGM) systems has long been recognized as a major challenge in comparing their results. However, a comprehensive characterization of the variability in study designs is currently unavailable. This article presents a scoping review of clinical CGM performance evaluations published between 2002 and 2022. Specifically, this review quantifies the prevalence of numerous options associated with various aspects of study design, including subject population, comparator (reference) method selection, testing procedures, and statistical accuracy evaluation. We found that there is a large variability in nearly all of those aspects and, in particular, in the characteristics of the comparator measurements. Furthermore, these characteristics as well as other crucial aspects of study design are often not reported in sufficient detail to allow an informed interpretation of study results. We therefore provide recommendations for reporting the general study design, CGM system use, comparator measurement approach, testing procedures, and data analysis/statistical performance evaluation. Additionally, this review aims to serve as a foundation for the development of a standardized CGM performance evaluation procedure, thereby supporting the goals and objectives of the Working Group on CGM established by the Scientific Division of the International Federation of Clinical Chemistry and Laboratory Medicine.
48.	Galavazi, Marije, 1977-, et al. (författare) Long-term effects of low energy diet combined with CBT-based group treatment of patients with obesity on weight, quality of life and eating behaviour : a 2-year intervention study 2018 Konferensbidrag (övrigt vetenskapligt/konstnärligt)
49.	Garcia-Argibay, Miguel, 1988-, et al. (författare) The association between type 2 diabetes and attention- deficit/hyperactivity disorder : a systematic review, meta-analysis, and population-based sibling study 2023 Ingår i: Neuroscience and Biobehavioral Reviews. - : Pergamon Press. - 0149-7634 .- 1873-7528. ; 147 Forskningsöversikt (refereegranskat)abstract We conducted a systematic review and a meta-analysis to quantitatively summarize evidence on the association between attention-deficit/hyperactivity disorder (ADHD) and type 2 diabetes (T2D). Moreover, a register-based sibling study was conducted to simultaneously control for confounding factors. A systematic search identified four eligible observational studies (N=5,738,287). The meta-analysis showed that individuals with ADHD have a more than doubled risk of T2D when considering adjusted estimates (OR=2.29 [1.48-3.55], d=0.46). Results from the register-based Swedish data showed a significant association between ADHD and T2D (HR=2.35 [2.14-2.58]), with substance use disorder, depression, and anxiety being the main drivers of the association, and cardiovascular and familiar risk playing a smaller role. While results from the meta-analysis provide evidence for an increased risk of T2D in individuals with ADHD, the register-based analyses show that the association between ADHD and T2D is largely explained by psychiatric comorbidities. Pending further evidence of causal association, our findings suggest that early identification and treatment of ADHD comorbidities might greatly reduce the risk of developing T2D in individuals with ADHD.
50.	Goodall, G., et al. (författare) Biphasic insulin aspart 70/30 vs. insulin glargine in insulin naïve type 2 diabetes patients : modelling the long-term health economic implications in a Swedish setting 2008 Ingår i: International journal of clinical practice (Esher). - : Wiley-Blackwell Publishing Inc.. - 1368-5031 .- 1742-1241. ; 62:6, s. 869-876 Tidskriftsartikel (refereegranskat)abstract OBJECTIVES: To evaluate the long-term clinical and economic outcomes of biphasic insulin aspart 70/30 (BIAsp 70/30) treatment vs. insulin glargine in insulin naïve, type 2 diabetes patients failing oral antidiabetic drugs in a Swedish setting.METHODS: A published and validated computer simulation model (the CORE Diabetes Model) was used to project life expectancy, quality-adjusted life expectancy (QALE) and costs over patient lifetimes. Cohort characteristics [54.5% male, mean age 52.4 years, 9 years mean diabetes duration, mean glycosylated haemoglobin (HbA1c) 9.77%] and treatment effects were based on results from the Initiate Insulin by Aggressive Titration and Education (INITIATE) clinical trial. Direct medical costs were accounted in 2006 Swedish Kronor (SEK) and economic and clinical benefits were discounted at 3% per annum.RESULTS: Biphasic insulin aspart 70/30 treatment when compared with insulin glargine treatment was associated with improvements in discounted life expectancy of 0.21 years (13.10 vs. 12.89 years) and QALE of 0.21 quality-adjusted life years (QALYs) (9.16 vs. 8.96 QALYs). Reductions in the incidence of diabetes-related complications in the BIAsp 70/30 treatment arm led to reduced total costs of SEK 10,367 when compared with insulin glargine (SEK 396,475 vs. SEK 406,842) over patient lifetimes. BIAsp 70/30 treatment was projected to be dominant (cost and lifesaving) when compared with insulin glargine in the base case analysis.CONCLUSIONS: Biphasic insulin aspart 70/30 treatment was associated with improved clinical outcomes and reduced costs compared with insulin glargine treatment over patient lifetimes. These results were driven by improved HbA1c levels associated with BIAsp 70/30 compared with insulin glargine and the accompanying reduction in diabetes-related complications despite increases in body mass index.

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