| 1. |
- Adolfsson, Peter, 1963, et al.
(författare)
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Improved Glycemic Control Observed in Children with Type 1 Diabetes Following the Introduction of Smart Insulin Pens: A Real-World Study
- 2022
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Ingår i: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 13, s. 43-56
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Many challenges are associated with optimizing glycemic control in pediatric patients with type 1 diabetes (T1D); combining data from smart insulin pens and continuous glucose monitoring (CGM) could mitigate some of these obstacles. Methods This one-arm, prospective, observational study investigated the effects of introducing a smart pen on glycemic control in pediatric patients with T1D who were using CGM. Children and adolescents with T1D who had been prescribed a smart pen for basal and/or bolus insulin injections were enrolled from three clinics in Sweden. Outcomes compared between baseline and follow-up (>= 12 months) included: mean numbers of daily (over 24 h) and nocturnal hypoglycemic or hyperglycemic events; time above range (TAR; > 180 mg/dL); time below range (TBR; level 1: 54 to < 70 mg/dL; level 2: < 54 mg/dL); time in range (TIR; 70-180 mg/dL); and missed bolus-dose (MBD) meals. Results Overall, 39 patients were included. Mean numbers of daily hypoglycemic events (- 31.4%; p = 0.00035) and nocturnal hypoglycemic events (- 24.4%; p = 0.043) were significantly reduced from baseline to follow-up. Mean daily TBR level 2 was reduced from 2.82% at baseline to 2.18% at follow-up (- 0.64 percentage points; p = 0.025). There were no statistically significant changes in number of daily hyperglycemic events, MBD meals, TIR, TAR, or TBR level 1. Conclusions Introducing smart insulin pens was associated with a reduced number of hypoglycemic events and decreases in TBR level 2, demonstrating a potential benefit for glycemic control in pediatric patients.
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| 2. |
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| 3. |
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| 4. |
- Ahrén, Bo, et al.
(författare)
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Postprandial Glucagon Reductions Correlate to Reductions in Postprandial Glucose and Glycated Hemoglobin with Lixisenatide Treatment in Type 2 Diabetes Mellitus : A Post Hoc Analysis
- 2016
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Ingår i: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 7:3, s. 583-590
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: The extent to which postprandial glucagon reductions contribute to lowering of postprandial glucose in patients with type 2 diabetes mellitus (T2DM) is currently unknown. The aim of this analysis was to determine whether a reduction in postprandial glucagon following treatment with the glucagon-like peptide-1 receptor agonist lixisenatide correlates with a reduction in postprandial glucose and glycated hemoglobin (HbA1c) in patients with T2DM. Methods: A post hoc analysis was performed on pooled data from the modified intent-to-treat populations of two lixisenatide Phase 3 trials: GetGoal-M (lixisenatide versus placebo as add-on to metformin) and GetGoal-S (lixisenatide versus placebo as add-on to sulfonylurea [SU] ± metformin). Glucagon levels were assessed 2 h after a standardized meal test performed at baseline and Week 24 and were examined for correlation with changes in 2-h postprandial glucose and HbA1c. Results: Lixisenatide reduced 2-h postprandial glucagon at Week 24 compared with placebo (P < 0.00001). The mean change in postprandial glucagon significantly correlated with reductions in postprandial glucose (P < 0.00001) and HbA1c (P < 0.00001). Conclusion: A reduction in postprandial glucagon following lixisenatide administration correlated with a decrease in postprandial glucose and HbA1c in patients with T2DM insufficiently controlled on metformin and/or SU. This suggests that lowering of postprandial glucagon contributes to the overall glycemic improvement observed with lixisenatide. Funding: Sanofi. Clinical Trial Numbers: NCT00712673 (GetGoal-M) and NCT00713830 (GetGoal-S).
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| 5. |
- Bernfort, Lars, et al.
(författare)
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Disease Burden and Healthcare Costs for T2D Patients With and Without Established Cardiovascular Disease in Sweden: A Retrospective Cohort Study
- 2020
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Ingår i: Diabetes Therapy. - : SPRINGER HEIDELBERG. - 1869-6953 .- 1869-6961. ; 11:7, s. 1537-1549
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionType 2 diabetes (T2D) is a complex chronic disease with an increasing prevalence worldwide. It is commonly associated with complications, such as cardiovascular disease (CVD). Patients with both T2D and established CVD are exposed to increased risk of further cardiovascular events, which means increased healthcare costs and impairments to quality of life and survival. To determine the added burden of CVD for T2D patients, we have analyzed the consumption and costs of healthcare and mortality in two T2D patient cohorts, with and without established CVD, respectively, during a 5-year follow-up in a Swedish region.MethodsPatients with T2D on 1 January 2012 were identified using the administrative database of Region ostergotland and the Swedish National Diabetes Register. Established CVD was defined as the presence of a CVD-related healthcare visit in the period 2002-2011. Identified T2D patients were then followed retrospectively for 5 years (2012-2016) and data collected on utilization of healthcare resources, healthcare costs, and survival. Data pertinent to the study were retrieved from regional databases and national registries.ResultsOn the index date (1 January 2012) there were 19,731 patients with T2D (prevalence 4.5%) in Region ostergotland, of whom 5490 had established CVD. Those patients with established CVD were older, more often men, and had longer diabetes duration and worse kidney function than those without. Compared to T2D patients without CVD, those with CVD had a significantly higher healthcare consumption, experienced higher costs, and had lower survival during the follow-up.ConclusionThis study confirms that established CVD is common among patients with T2D (approximately 30%). Established CVD has negative effects on the utilization of healthcare resources, healthcare costs, and mortality. It is therefore very important to improve the treatment strategy of this patient group.
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| 6. |
- Bernfort, Lars, et al.
(författare)
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Implementation of Empagliflozin in Patients with Diabetes Mellitus Type 2 and Established Cardiovascular Disease : Estimation of 5-Year Survival and Costs in Sweden
- 2020
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Ingår i: Diabetes Therapy. - : Springer Berlin/Heidelberg. - 1869-6953 .- 1869-6961. ; 11, s. 2921-2930
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionCardiovascular disease (CVD) affects approximately 30% of patients with diabetes mellitus type 2 (T2D) and leads to increased morbidity, decreased survival and increased healthcare utilization. The aim of this study was to estimate the impact of treating these patients with the sodium–glucose cotransporter 2 (SGLT2) inhibitor empagliflozin on survival and healthcare utilization.MethodsActual survival and healthcare utilization data from a 5-year retrospective cohort study on patients with T2D and CVD in the Region of Östergötland, Sweden were used as a starting point. Actual data were adjusted in accordance with risk reductions for mortality and CV events related to empagliflozin treatment as reported in the EMPA-REG OUTCOME study.ResultsApplying the risk reductions related to empagliflozin treatment on the cohort of patients with T2D and CVD in Östergötland resulted in an increase in 5-year survival of 96 days per patient and reduced costs for healthcare and drugs other than empagliflozin. Including the cost of empagliflozin, treatment led to an increased net cost per patient of approximately SEK 18,000 over 5 years.ConclusionEmpagliflozin treatment would reduce mortality and healthcare utilization in the patient group. The treatment strategy should be considered cost-effective, supporting a broad implementation of empagliflozin for patients with T2D and established CVD, in line with current national and international guidelines.
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| 7. |
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| 8. |
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| 9. |
- Blissett, D. B., et al.
(författare)
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Analysis Estimating the Potential Cost Impact of Utilizing Flash Glucose Monitoring with Optional Alarms in Swedish Adults with Diabetes with Impaired Awareness of Hypoglycaemia, Using Intensive Insulin
- 2021
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Ingår i: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 12:8, s. 2179-2193
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Tidskriftsartikel (refereegranskat)abstract
- Introduction The objective of this analysis was to estimate the costs associated with using flash glucose monitoring with optional alarms as a replacement for either traditional continuous glucose monitoring (CGM) or routine self-monitoring of blood glucose (SMBG) in adults with diabetes and impaired awareness of hypoglycaemia (IAH) who use intensified insulin therapy, from a Swedish payer perspective, applying assumptions to simulate hypothetical scenarios. Methods A simple two-state cohort Markov model was used to calculate the cost per patient treated over a 3-year period, capturing the risk of severe hypoglycaemic events requiring medical assistance and non-adherence using quarterly Markov cycles. The costs considered were those for glucose monitoring and resource use to treat severe hypoglycaemic events. Cost inputs were sourced from Swedish price lists, manufacturer data and resource use reported in the control arm of the HypoDE study. Targeted literature searches were run in PubMed to source the clinical inputs. Uncertainty in the model was considered through one-way sensitivity analysis and scenario analysis. Results Over 3 years, flash monitoring with optional alarms resulted in potential cost-savings of Swedish krona (SEK) 7708 and SEK 69,908 per patient when compared to routine SMBG or CGM respectively. Sensitivity and scenario analyses were largely supportive of this conclusion with respect to SMBG, and large cost-savings were consistent across all sensitivity and scenario analyses with respect to CGM. Conclusion Utilizing flash monitoring with optional alarms is potentially a cost-saving treatment strategy compared to routine SMBG or traditional CGM in adults with diabetes using intensive insulin and IAH from a Swedish payer perspective. Future studies in the IAH population will help to assess more precisely the relative cost impact of flash glucose monitoring with optional alarms compared with SMBG and traditional CGM.
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| 10. |
- Cederblad, Lars, et al.
(författare)
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Classification of Hypoglycemic Events in Type 1 Diabetes Using Machine Learning Algorithms
- 2023
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Ingår i: Diabetes Therapy. - : Springer Nature. - 1869-6953 .- 1869-6961. ; 14:6, s. 953-965
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionTo improve the utilization of continuous- and flash glucose monitoring (CGM/FGM) data we have tested the hypothesis that a machine learning (ML) model can be trained to identify the most likely root causes for hypoglycemic events.MethodsCGM/FGM data were collected from 449 patients with type 1 diabetes. Of the 42,120 identified hypoglycemic events, 5041 were randomly selected for classification by two clinicians. Three causes of hypoglycemia were deemed possible to interpret and later validate by insulin and carbohydrate recordings: (1) overestimated bolus (27%), (2) overcorrection of hyperglycemia (29%) and (3) excessive basal insulin presure (44%). The dataset was split into a training (n = 4026 events, 304 patients) and an internal validation dataset (n = 1015 events, 145 patients). A number of ML model architectures were applied and evaluated. A separate dataset was generated from 22 patients (13 ‘known’ and 9 ‘unknown’) with insulin and carbohydrate recordings. Hypoglycemic events from this dataset were also interpreted by five clinicians independently.ResultsOf the evaluated ML models, a purpose-built convolutional neural network (HypoCNN) performed best. Masking the time series, adding time features and using class weights improved the performance of this model, resulting in an average area under the curve (AUC) of 0.921 in the original train/test split. In the dataset validated by insulin and carbohydrate recordings (n = 435 events), i.e. ‘ground truth,’ our HypoCNN model achieved an AUC of 0.917.ConclusionsThe findings support the notion that ML models can be trained to interpret CGM/FGM data. Our HypoCNN model provides a robust and accurate method to identify root causes of hypoglycemic events.
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| 11. |
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| 12. |
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| 13. |
- de Valk, Harold W., et al.
(författare)
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Switching to Degludec is Associated with Reduced Hypoglycaemia, Irrespective of Definition Used or Patient Characteristics : Secondary Analysis of the ReFLeCT Prospective, Observational Study
- 2020
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Ingår i: Diabetes Therapy. - : Springer. - 1869-6953 .- 1869-6961. ; 11:9, s. 2159-2167
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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.
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| 14. |
- Dena, Mary, et al.
(författare)
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Renal Complications and Duration of Diabetes: An International Comparison in Persons with Type 1 Diabetes
- 2021
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Ingår i: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; :12, s. 3093-3105
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Renal complications are both a marker of previous suboptimal glycaemic control and a major risk factor for cardiovascular disease in persons with type 1 diabetes (T1D). The aim of the study was to evaluate the prevalence of renal complications in persons with T1D in four geographical regions. Methods Nationwide registry data from Austria/Germany, Sweden and the US were used to estimate the prevalence of renal complications from January 2016 until September 2018. Chronic kidney disease (CKD) and albuminuria in the study population and each registry were analysed by diabetes duration. Risk factors for renal complications were described by registry. Results In the total cohort of 78.926 adults with T1D, mean age was 44.4 +/- 18.43 years and mean diabetes duration was 21.6 +/- 22 years. Mean estimated glomerular filtration rate (eGFR) was 94.0 +/- 31.45 ml/min, 13.0% had microalbuminuria and 3.9% had macroalbuminuria. Mean age, diabetes duration, use of insulin pumps and continuous glucose monitoring, as well as presence of albuminuria, varied between registries. Albuminuria was present in approximately 10% of persons with diabetes duration < 20 years and impaired renal function (eGFR < 60 ml/min) was present in 17%. In persons with diabetes duration > 40 years, approximately one-third had albuminuria and 25% had impaired renal function. Conclusions This analysis used three nationwide registries of persons with T1D. Despite recent use of more effective diabetes therapies, a substantial proportion of persons with T1D have renal complications at < 20 years after diagnosis. Efficient glucose-lowering and renal-protective strategies are needed in persons with T1D.
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| 15. |
- Dwibedi, Chinmay, 1987, et al.
(författare)
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Effect of Digital Lifestyle Management on Metabolic Control and Quality of Life in Patients with Well-Controlled Type 2 Diabetes
- 2022
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Ingår i: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 13, s. 423-439
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Tidskriftsartikel (refereegranskat)abstract
- Introduction The lack of effective, scalable solutions for lifestyle treatment is a global clinical problem, causing severe morbidity and mortality. Digital tools could enable broad utility, but long-term metabolic outcomes and the influence on quality of life are unclear. Methods We developed a new method for lifestyle treatment that promotes self-reflection and iterative behavioural change, provided as a digital tool, and evaluated its effect on glycaemic control in patients with type 2 diabetes with HbA1c below 52 mmol/mol (n = 297). As a secondary analysis, its effect on quality of life (using SF-12) was examined in both participants with and without diabetes (total n = 1914). The tool was evaluated during a 12-week randomization period to assess the existence of effect, with a subsequent open-label follow-up to study long-term outcomes. Results Participants were randomized to wait or access the intervention tool. The mean difference in HbA1c was 2 mmol/mol (95% CI - 4 to 0; P = 0.02) after 12 weeks in participants with type 2 diabetes. The groups were then merged to enable all participants to use the tool. The mean HbA1c reduction from baseline in patients with type 2 diabetes using the tool was 2 mmol/mol compared with matched controls (95% CI - 3 to 0; P = 0.005). In users with HbA1c above 45 mmol/mol, the mean difference between the groups was 4 mmol/mol (95% CI - 7 to - 2). The improvements were sustained during the follow-up of 1 year on average. Users of the tool also had improved quality of life from baseline to 6 months, mainly observed in non-diabetic participants. Conclusion The tool does not require in-person reinforcement or increased healthcare resources, and the marginal cost is fundamentally lower than pharmacological treatment and most existing lifestyle interventions. The results therefore open a new means for self-managed lifestyle treatment with long-term metabolic efficacy that can benefit large numbers of people.
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| 16. |
- Eliasson, Bjoern, et al.
(författare)
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Associations Between HbA1c and Glucose Time in Range Using Continuous Glucose Monitoring in Type 1 Diabetes: Cross-Sectional Population-Based Study
- 2024
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Ingår i: DIABETES THERAPY. - 1869-6953 .- 1869-6961. ; 15:6, s. 1301-1312
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Continuous glucose monitoring (CGM) introduces novel indicators of glycemic control.Methods This cross-sectional study, based on the Swedish National Diabetes Register, examines 27,980 adults with type 1 diabetes. It explores the relationships between HbA1c (glycated hemoglobin) and various CGM-derived metrics, including TIR (time in range, representing the percentage of time within the range of 4-10 mmol/l for 2 weeks), TAR (time above range), TBR (time below range), mean glucose, standard deviation (SD), and coefficient of variation (CV). Pearson correlation coefficients and linear regression models were utilized for estimation.Results The analysis included 46% women, 30% on insulin pump, 7% with previous coronary heart disease and 64% with retinopathy. Mean +/- SD values were age 48 +/- 18 years, diabetes duration 25 +/- 16 years, HbA1c 58.8 +/- 12.8 mmol/mol, TIR 58.8 +/- 19.0%, TAR 36.3 +/- 20.0%, TBR 4.7 +/- 5.4%, mean sensor glucose 9.2 +/- 2.0 mmol/l, SD 3.3 +/- 1.0 mmol/l, and CV 36 +/- 7%. The overall association between HbA1c and TIR was - 0.71 (Pearson's r), with R 2 0.51 in crude linear regression and 0.57 in an adjusted model. R 2 values between HbA1c and CGM mean glucose were 0.605 (unadjusted) 0.619 (adjusted) and TAR (unadjusted 0.554 and fully adjusted 0.568, respectively), while fully adjusted R 2 values were 0.458, 0.175 and 0.101 between HbA1c and CGM SD, CGM CV and TBR, respectively.Conclusions This descriptive study demonstrates that the degree of association between HbA1c and new and readily available CGM-derived metrics, i.e., time in range (TIR), time above range (TAR), and CGM mean glucose, is robust in assessing the management of individuals with type 1 diabetes in clinical settings. Metrics from CGM that pertain to variability and hypoglycemia exhibit only weak correlations with HbA1c.
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| 17. |
- Eliasson, Björn, 1959, et al.
(författare)
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Cardiovascular Disease in Patients with Type 2 Diabetes and in Patients Starting Empagliflozin Treatment: Nationwide Survey
- 2019
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Ingår i: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 10:4, s. 1523-1530
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionWere the participants of the EMPA-REG OUTCOME trial representative of patients receiving empagliflozin in clinical practice? The aim of the present study was to examine the prevalence of cardiovascular disease (CVD) in type 2 diabetes patients starting empagliflozin treatment in routine clinical practice in Sweden.MethodsWe used nationwide data from the Swedish National Diabetes Register (NDR), the Swedish Prescribed Drug Register, and the Swedish National Patient Register to provide clinical characteristics and ongoing treatments.ResultsThe total study cohort included 460,558 patients, of whom 130,508 (28.3%) had a history of CVD. The number of patients starting empagliflozin during the study period was 16,985. Among these, 1952 (11.5%) had a history of CVD. The patients starting empagliflozin were younger than the total cohort and were more likely to have retinopathy despite having a similar duration of diabetes to the overall cohort. They also exhibited higher BMI, HbA1c, and eGFR, and were more likely to be treated with insulin and lipid-lowering and blood-pressure-lowering medications. The patients with CVD who were starting empagliflozin were slightly older and had been diabetic for slightly longer than the patients without CVD who were starting empagliflozin, but they also had lower eGFR. Among the patients with CVD who were starting empagliflozin, 87% had coronary heart disease, 8% had suffered a stroke, 13% had peripheral artery disease, 16% had atrial fibrillation, and 20% had congestive heart failure.ConclusionThe prevalence of CVD in patients with type 2 diabetes in clinical practice in Sweden was 28.3% during the study period, and it was 11.5% in the patients starting empagliflozin treatment. Patients of the latter cohort were, however, younger, more obese, and more likely to have unsatisfactory glycemic control, requiring additional treatment. Overall, a large proportion of type 2 diabetes patients should be considered at high cardiovascular risk.FundingBoehringer Ingelheim AB, Sweden.
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| 18. |
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| 19. |
- Eliasson, Björn, 1959, et al.
(författare)
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Persistence with IDegLira in Patients in Clinical Practice: A Nationwide Observational Study in Sweden
- 2020
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Ingår i: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 11, s. 1807-1820
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Tidskriftsartikel (refereegranskat)abstract
- Aims To explore persistence with insulin degludec/liraglutide (IDegLira) treatment, clinical characteristics and concomitant medications in a large population of patients in clinical practice. Methods This was an observational study in patients with type 2 diabetes (n = 2432) who initiated IDegLira between 26 May 2015 and 31 December 2017. Data were obtained from Swedish nationwide registers and linked on an individual level using unique Swedish personal identifiers. Dose calculations were made for patients with >= 180 days between the first and last collections of IDegLira prescription. Changes in clinical parameters were evaluated as change from the last observation during 12 months prior to the initiation date until +/- 90 days from the last collection of IDegLira. Results Pre-index regimens (index date being the date of filling the first prescription of IDegLira) included: multiple daily insulin injections (45.1%); insulin and glucagon-like peptide-1 receptor agonist (GLP-1 RA) (19.7%); long-acting insulins (11.8%); non-injectable therapy only (11.4%); GLP-1 RA only (9.8%); and no collection of diabetes medication during the 6-month pre-index period (2.3%). The majority of patients (94 and 84%) were persistent with IDegLira at 6 and 12 months, respectively. The most commonly used concomitant medication was metformin (69.4%). Mean daily dose was 33 dose steps. Overall, there was a mean decrease in HbA1c (approx. 10 mmol/mol [1%]) and body weight (- 1.1 kg). Improvements in HbA1c were observed regardless of pre-index treatment. Conclusion After 12 months, 84% of patients were persistent on IDegLira, with improved glycaemic control and reductions in body weight.
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| 20. |
- Hero, Christel, et al.
(författare)
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Impact of Socioeconomic Factors and Gender on Refill Adherence and Persistence to Lipid-Lowering Therapy in Type 1 Diabetes
- 2021
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Ingår i: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 12:9, s. 2371-2386
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Lipid-lowering therapy (LLT) reduces the risk of cardiovascular disease (CVD) in patients with type 1 diabetes (T1D). However, socioeconomic factors and gender may have an impact on the adherence to and non-persistence with LLT. Methods This was a nationwide register-based cohort study that included 6192 individuals with T1D aged >= 18 years who were registered in the Swedish National Diabetes Register and had initiated novel use of LLT. Information on socioeconomic parameters (source: Statistics Sweden) and comorbidity (source: National Patient Register) was collected. The individuals were followed for 36 months, and adherence to LLT was analyzed according to age, socioeconomics and gender. The medication possession ratio (MPR; categorized into <= 80% and > 80%) and non-persistence (discontinuation) with medication was calculated after 18 and 36 months. Results Individuals older than 53 years were more adherent to LLT (MPR > 80%) than those younger than 36 years (odds ratio [(OR] 1.30, p < 0.0001) at 36 months. Women were more adherent and less prone to discontinue LLT at 18 months (OR 1.05, p = 0.0005 and OR 0.95, p = 0.0004, respectively), but not at 36 months. Divorced individuals were less adherent than married ones (OR 0.93, p = 0.0005) and discontinued LLT more often than the latter (OR 1.06, p = 0.003). Education had no impact on adherence, but individuals with higher incomes discontinued LLT less frequently than those with lower incomes. Individuals with a country of origin other than Sweden discontinued LLT more often. Conclusion Lower adherence to LLT in individuals with T1D was associated with male gender, younger age, marital status and country of birth. These factors should be considered when evaluating adherence to LLT in clinical practice, with the aim to help patients achieve full cardioprotective treatment.
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| 21. |
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| 22. |
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| 23. |
- Jendle, Johan, 1963-, et al.
(författare)
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Achieving Good Glycemic Control Early After Onset of Diabetes : A Cost-Effectiveness Analysis in Patients with Type 1 Diabetes in Sweden
- 2018
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Ingår i: Diabetes Therapy. - : Springer. - 1869-6953 .- 1869-6961. ; 9:1, s. 87-99
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Sweden has amongst the highest incidence rates of type 1 diabetes (T1D) in Europe. The high incidence and chronic nature of T1D result in high prevalence and economic burden. Improving glycemic control reduces the incidence of microvascular complications, which in turn reduces medical costs. The present study aimed to quantify the reductions in cost and improvements in quality-adjusted life expectancy with varying reductions in HbA1c in the T1D population.METHODS: The IQVIA CORE Diabetes Model was used to simulate a typical Swedish population of patients with T1D experiencing HbA1c reductions from 0.1% to 0.8% (in 0.1% increments) from 7.9% at baseline. Analyses were conducted in simulated cohorts based on data from the Swedish National Diabetes Register (NDR) and in subgroups by sex, smoking status, and body mass index (BMI), with different sets of quality-of-life utilities included. Generalized least squares (GLS) models were used to test for significant differences between subgroups. Analyses were also performed to investigate the effect of the duration of HbA1c control. Analyses were run over 50 years and outcomes discounted at 3% per annum.RESULTS: In the reference case analysis, reducing HbA1c lowered the incidence of microvascular and macrovascular complications and improved quality-adjusted life expectancy. GLS models identified a significantly larger benefit of reducing HbA1c in women over men, but found no significant differences in the magnitude of quality of life improvements with decreasing HbA1c when segregating by smoking status or BMI.CONCLUSIONS: Reducing HbA1c in a population with T1D would reduce the incidence of microvascular complications, improve life expectancy and quality of life. Larger quality-of-life benefits were observed in younger and female adult patients, but no notable differences were observed in the benefits of glycemic control in smokers versus non-smokers or in patients with low or high BMI.
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| 24. |
- Jendle, Johan, 1963-, et al.
(författare)
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Cost-Effectiveness Analysis of Sensor-Augmented Insulin Pump Therapy with Automated Insulin Suspension Versus Standard Insulin Pump Therapy in Patients with Type 1 Diabetes in Sweden
- 2017
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Ingår i: Diabetes Therapy. - : Springer Berlin/Heidelberg. - 1869-6953 .- 1869-6961. ; 8:5, s. 1015-1030
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: In Sweden an estimated 10,000 people with type 1 diabetes use continuous subcutaneous insulin infusion (CSII). Sensor-augmented pump therapy (SAP) is associated with higher acquisition costs but provides additional clinical benefits (e.g. reduced rate of hypoglycemic events) over and above that of CSII alone. The aim of the analysis was to assess the cost-effectiveness of SAP with automated insulin suspension relative to CSII alone in two different groups of patients with type 1 diabetes in Sweden.Methods: Cost-effectiveness analyses were performed using the QuintilesIMS CORE Diabetes Model, with clinical and economic input data derived from published literature. Separate analyses were performed for patients at increased risk of hypoglycemia and for patients with uncontrolled glycated hemoglobin (HbA1c) at baseline. Analyses were performed from a societal perspective over a lifetime time horizon. Future costs and clinical outcomes were discounted at 3% per annum.Results: SAP with automated insulin suspension was associated with an incremental gain in quality-adjusted life expectancy versus the CSII of 1.88 quality-adjusted life years (QALYs) in patients at high risk of hypoglycemia and of 1.07 QALYs in patients with uncontrolled HbA1c at baseline. Higher lifetime costs for SAP with automated insulin suspension resulted in projected incremental cost-effectiveness ratios for the SAP with automated insulin suspension versus CSII of Swedish Krona (SEK) 139,795 [euros (EUR) 14,648] per QALY gained for patients at increased risk for hypoglycemia and SEK 251,896 (EUR 26,395) per QALY gained for patients with uncontrolled HbA1c. In both groups, SAP with automated insulin suspension also reduced the incidence of diabetes-related complications relative to CSII.Conclusions: In Sweden, SAP with automated insulin suspension likely represents a cost-effective treatment option relative to CSII for the management of patients with type 1 diabetes with a history of severe hypoglycemic events or patients who struggle to achieve good glycemic control despite the use of CSII.
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| 25. |
- Jendle, Johan, 1963-, et al.
(författare)
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Cost-Effectiveness of the FreeStyle Libre(R) System Versus Blood Glucose Self-Monitoring in Individuals with Type 2 Diabetes on Insulin Treatment in Sweden
- 2021
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Ingår i: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 12, s. 3137-3152
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Frequent glucose monitoring is essential to obtain glucose control. This is done by periodic self-monitoring of blood glucose (SMBG) using finger-prick testing, or by using continuous glucose monitoring devices, wherein a sensor records interstitial glucose data automatically. This study assessed the cost-effectiveness of using the FreeStyle Libre Flash Continuous Glucose Monitoring System (FSL) compared to SMBG in individuals with type 2 diabetes (T2D) treated with insulin from a Swedish societal perspective. Methods Cost-effectiveness analysis was conducted using the IQVIA Core Diabetes model v9.5, with demographic and clinical inputs from a real-world study using Swedish National Diabetes Register data. Two cohorts of individuals with T2D were considered based on baseline HbA1C (HbA1c: 8-9% [64-75 mmol/mol]; HbA1c: 9-12% [75-108 mmol/mol]). HbA1c reductions with FSL were - 0.41% (- 4 mmol/mol; SD: 0.94%-10 mmol/mol) and - 1.30% (- 14 mmol/mol; SD: 1.40%-15 mmol/mol) for the two cohorts, respectively. Utilities, treatment costs and diabetes-related complication costs were obtained from published sources. Analyses were conducted over a lifetime horizon, applying annual discounting of 3% on costs and effects. Scenario analyses and probabilistic sensitivity analyses were performed. Results Individuals with T2D who had a baseline HbA1c of 8-9% (64-75 mmol/mol) and 9-12% (75-108 mmol/mol) and used FSL gained 0.50 and 0.57 quality-adjusted life-years (QALYs), respectively, at an incremental cost of SEK109,957 and SEK82,170 compared to SMBG, generating an incremental cost-utility ratio of SEK219,127 and SEK144,412 per QALY gained. Assuming a willingness-to-pay threshold of SEK300,000 per QALY gained, FSL use was considered cost-effective compared to SMBG for the majority of the individuals in both the lower and higher HbA1c cohorts. The key driver identified was the additional quality-of-life benefit that applied to FSL use. Conclusion The FreeStyle Libre Flash Continuous Glucose Monitoring System is a cost-effective glucose monitoring alternative to SMBG for individuals with T2D in Sweden who are treated with insulin but are not reaching their glycaemic goals.
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| 26. |
- Jendle, Johan, 1963-, et al.
(författare)
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Smart Insulin Pens are Associated with Improved Clinical Outcomes at Lower Cost Versus Standard-of-Care Treatment of Type 1 Diabetes in Sweden : A Cost-Effectiveness Analysis
- 2021
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Ingår i: Diabetes Therapy. - : Springer. - 1869-6953 .- 1869-6961. ; 12:1, s. 373-388
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Real-world evidence has demonstrated improved glycemic control and insulin management following introduction of smart insulin pens in a Swedish type 1 diabetes (T1D) population. To understand the implications for healthcare costs and expected health outcomes, this analysis evaluated the long-term cost-effectiveness of introducing smart insulin pens to standard-of-care T1D treatment (standard care) from a Swedish societal perspective.METHODS: Clinical outcomes and healthcare costs (in 2018 Swedish krona, SEK) were projected over patients' lifetimes using the IQVIA CORE Diabetes Model to estimate cost-effectiveness. Clinical data and baseline characteristics for the simulated cohort were informed by population data and a prospective, noninterventional study of a smart insulin pen in a Swedish T1D population. This analysis captured direct and indirect costs, mortality, and the impact of diabetes-related complications on quality of life.RESULTS: Over patients' lifetimes, smart insulin pen use was associated with per-patient improvements in mean discounted life expectancy (+ 0.90 years) and quality-adjusted life expectancy (+ 1.15 quality-adjusted life-years), in addition to mean cost savings (direct, SEK 124,270; indirect, SEK 373,725), versus standard care. A lower frequency and delayed onset of complications drove projected improvements in quality-adjusted life expectancy and lower costs with smart insulin pens versus standard care. Overall, smart insulin pens were a dominant treatment option relative to standard care across all base-case and sensitivity analyses.CONCLUSIONS: Use of smart insulin pens was projected to improve clinical outcomes at lower costs relative to standard care in a Swedish T1D population and represents a good use of healthcare resources in Sweden.
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| 27. |
- Jendle, Johan, 1963-, et al.
(författare)
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The Cost-Effectiveness of an Advanced Hybrid Closed-Loop System in People with Type 1 Diabetes : a Health Economic Analysis in Sweden
- 2021
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Ingår i: Diabetes Therapy. - : Springer. - 1869-6953 .- 1869-6961. ; 12:11, s. 2977-2991
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Swedish National Diabetes Registry data show a correlation of improved glycemic control in people with type 1 diabetes (T1D) with increased use of diabetes technologies over the past 25 years. However, novel technologies are often associated with a high initial outlay. The aim of the present study was to evaluate the long-term cost-effectiveness of the advanced hybrid closed-loop (AHCL) MiniMed 780G system versus intermittently scanned continuous glucose monitoring (isCGM) plus self-injection of multiple daily insulin (MDI) or continuous subcutaneous insulin infusion (CSII) in people with T1D in Sweden.METHODS: Outcomes were projected over patients' lifetimes using the IQVIA CORE Diabetes Model (v9.0). Clinical data, including changes in glycated hemoglobin (HbA1c) and hypoglycemia rates, were sourced from observational studies and a randomized crossover trial. Modeled patients were assumed to receive the treatments for their lifetimes, with HbA1c kept constant following the application of treatment effects. Costs were accounted from a societal perspective and expressed in Swedish krona (SEK). Utilities and days off work estimates were taken from published sources.RESULTS: The MiniMed 780G system was associated with an improvement in life expectancy of 0.16 years and an improvement in quality-adjusted life expectancy of 1.95 quality-adjusted life years (QALYs) versus isCGM plus MDI or CSII. These clinical benefits were due to a reduced incidence and a delayed time to onset of diabetes-related complications. Combined costs were estimated to be SEK 727,408 (EUR 72,741) higher with MiniMed 780G, with treatment costs partially offset by direct cost savings from the avoidance of diabetes-related complications and indirect cost savings from the avoidance of lost workplace productivity. The MiniMed 780G system was associated with an incremental cost-effectiveness ratio of SEK 373,700 per QALY gained.CONCLUSIONS: Based on a willingness-to-pay threshold of SEK 500,000 per QALY gained, the MiniMed 780G system was projected to be cost-effective versus isCGM plus MDI or CSII for the treatment of T1D in Sweden.
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| 28. |
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| 29. |
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| 30. |
- Lak, Vincent Wai-Ming, et al.
(författare)
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Clinical Effects and Safety of Direct-Acting Insulin Analogs in Patients with Type 1 Diabetes: A Nation-Wide Observational Cohort Study
- 2016
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Ingår i: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 7:3, s. 561-573
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Tidskriftsartikel (refereegranskat)abstract
- Studies comparing direct-acting insulin analogs (DAIs) in terms of effectiveness and long-term safety are scarce. Our aim was to explore these variables in clinical practice among patients with type 1 diabetes, including the elderly and those with renal impairment. We linked four national registers in a population-based cohort study. Patients with type 1 diabetes and continuous use of all currently available DAIs (lispro, aspart, or glulisine) in 2005-2013 were monitored for up to 7.5 years. Inverse probability of treatment weighting was used to adjust for differences in baseline characteristics between treatment groups. Unadjusted mean HbA1c and weights were plotted. Hazard ratios and 95% confidence intervals of cardiovascular events (CVEs) and mortality were estimated using Cox proportional hazards regression models. We included 41,165 patients-14,047 lispro, 26,813 aspart, and 305 glulisine users. At baseline, the mean age was highest among glulisine users (49.4 years), followed by 41.0 years for lispro users and 40.1 years for aspart users. A total of 9.2% of the patients were 65 years or older. Diabetes duration was shortest among glulisine users (11.6 years), followed by 15.4 years for aspart users and 19.5 years for lispro users. The mean HbA1c and weights during the follow-up period were similar. The numerical differences at baseline were subsequently adjusted for. There were no significant differences between groups regarding hyperglycemia requiring hospitalization, CVE, or mortality, while Cox regression suggested lower rates of hypoglycemia among glulisine users. Severe hypoglycemia was more common, and severe hyperglycemia was less common among patients aged 65 years or older, while severe hypoglycemia and hyperglycemia were more common in patients with low renal function (estimated glomerular filtration rate). There were no pronounced differences in effectiveness and long-term cardiovascular safety and mortality between the DAIs, although there were some differences in clinical characteristics between patients using the three types of insulin. Severe hypoglycemia was more common among older patients, while severe hypoglycemia and hyperglycemia were more common among patients with impaired renal function.
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| 31. |
- Lind, Marcus, 1976, et al.
(författare)
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Fast-Acting Insulin Aspart in Patients with Type 1 Diabetes in Real-World Clinical Practice: A Noninterventional, Retrospective Chart and Database Study
- 2023
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Ingår i: Diabetes Therapy. - : Springer. - 1869-6953 .- 1869-6961. ; 14, s. 1563-1575
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionThis study utilized continuous glucose monitoring data to analyze the effects of switching to treatment with fast-acting insulin aspart (faster aspart) in adults with type 1 diabetes (T1D) in clinical practice.MethodsA noninterventional database review was conducted in Sweden among adults with T1D using multiple daily injection (MDI) regimens who had switched to treatment with faster aspart as part of basal-bolus treatment. Glycemic data were retrospectively collected during the 26 weeks before switching (baseline) and up to 32 weeks after switching (follow-up) to assess changes in time in glycemic range (TIR; 70-180 mg/dL), mean sensor glucose, glycated hemoglobin (HbA1c) levels, coefficient of variation, time in hyperglycemia (level 1, > 180 to & LE; 250 mg/dL; level 2, > 250 mg/dL), and time in hypoglycemia (level 1, & GE; 54 to < 70 mg/dL; level 2, < 54 mg/dL) (ClinicalTrials.gov Identifier NCT03895515).ResultsOverall, 178 participants were included in the study cohort. The analysis population included 82 individuals (mean age 48.5 years) with adequate glucose sensor data. From baseline to follow-up, statistically significant improvements were reported for TIR (mean increase 3.3%-points [approximately 48 min/day]; p = 0.006) with clinically relevant improvement (& GE; 5%) in 43% of participants. Statistically significant improvements from baseline were observed for mean sensor glucose levels, HbA1c levels, and time in hyperglycemia (levels 1 and 2), with no statistically significant changes in time spent in hypoglycemia.ConclusionsSwitching to faster aspart was associated with improvements in glycemic control without increasing hypoglycemia in adults with T1D using MDI in this real-world setting.
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| 32. |
- Lindh, Magnus, 1960, et al.
(författare)
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Clinical Effectiveness of Liraglutide vs Sitagliptin on Glycemic Control and Body Weight in Patients with Type 2 Diabetes: A Retrospective Assessment in Sweden
- 2016
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Ingår i: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 7:2, s. 321-333
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: The aim of the present study was to use real-world data from Swedish primary-care and national registries to understand clinical outcomes in patients with Type 2 diabetes (T2D) treated with liraglutide in clinical practice, and to compare with data from those treated with sitagliptin. Methods: This was a non-interventional, retrospective study conducted between February 2014 and September 2014 using T2D patient data from Swedish primary-care centers and national healthcare registries. The primary objective was to assess the effectiveness of liraglutide in control of glycemia and body weight in clinical practice (stage 1). The secondary objective was to compare the clinical effectiveness of liraglutide with sitagliptin on glycemic control and body weight in clinical practice in a propensity-score-matched population (stage 2). Results: In stage 1 (n = 402), 39.4% of patients treated with liraglutide achieved >= 1.0% (10.9 mmol/mol) reduction in glycated hemoglobin (HbA1c) after 180 days of treatment and 54.9% achieved the target HbA1c of <7.0% (53.0 mmol/mol). Moreover, compared with baseline, 22.5% of patients treated with liraglutide achieved both >= 1.0% reduction in HbA1c and >= 3.0% reduction in body weight. In stage 2, a significantly greater proportion of patients receiving liraglutide (n = 180) than sitagliptin (n = 208) achieved >= 1.0% reduction in HbA1c [52.9% vs 33.5%, respectively (P = 0.0002)]. Mean body-weight loss was also significantly greater in patients receiving liraglutide vs sitagliptin [-3.5 vs -1.3 kg, respectively (P < 0.0001)]. Conclusion: This study provides real-world evidence from Sweden corroborating previous clinical trials that demonstrate greater efficacy of liraglutide over sitagliptin on glycemic control and body-weight reduction in patients with T2D.
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| 33. |
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| 34. |
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| 35. |
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| 36. |
- Neeland, Ian J, et al.
(författare)
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Comparison of Adipose Distribution Indices with Gold Standard Body Composition Assessments in the EMPA-REG H2H SU Trial: A Body Composition Sub-Study.
- 2015
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Ingår i: Diabetes therapy : research, treatment and education of diabetes and related disorders. - : Springer Science and Business Media LLC. - 1869-6953. ; 6:4, s. 635-642
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Tidskriftsartikel (refereegranskat)abstract
- Excess adiposity contributes to cardiometabolic disease. Although adipose depots can be measured using imaging, implementation remains limited in practice. Data comparing surrogate indices of total and visceral adiposity with gold standard measurements in the context of a clinical trial population are lacking. We explored the relationships between adipose distribution indices and imaging assessments of body composition using baseline data from the EMPA-REG H2H SU™ trial.
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| 37. |
- Pereira, Maria J, 1981-, et al.
(författare)
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A Randomized Controlled Trial of Dapagliflozin Plus Once-Weekly Exenatide Versus Placebo in Individuals with Obesity and Without Diabetes : Metabolic Effects and Markers Associated with Bodyweight Loss
- 2018
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Ingår i: Diabetes Therapy. - : Springer Berlin/Heidelberg. - 1869-6953 .- 1869-6961. ; 9:4, s. 1511-1532
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Tidskriftsartikel (refereegranskat)abstract
- The sodium-glucose cotransporter 2 inhibitor dapagliflozin and the glucagon-like peptide-1 (GLP-1) receptor agonist exenatide reduce bodyweight via differing and complementary mechanisms. This post hoc analysis investigated the metabolic effects and baseline associations with bodyweight loss on coadministration of dapagliflozin and exenatide once weekly (QW) among adults with obesity and without diabetes. In the primary trial, adults with obesity and without diabetes [n = 50; 18-70 years; body mass index (BMI) 30-45 kg/m(2)] were randomized to double-blind oral dapagliflozin 10 mg (DAPA) once daily plus subcutaneous long-acting exenatide 2 mg QW (ExQW) or placebo over 24 weeks, followed by an open-label extension from 24-52 weeks during which all participants received active treatment. Primary results have been published previously. This analysis evaluated: (1) the effects of DAPA + ExQW on changes in substrates [free fatty acids (FFAs), glycerol, beta-OH-butyrate, and glucose], hormones (glucagon and insulin), and insulin secretion [insulinogenic index (IGI)] via an oral glucose tolerance test (OGTT) and (2) associations between bodyweight loss and baseline characteristics (e.g., BMI), single-nucleotide polymorphisms (SNPs) associated with the GLP-1 pathway, and markers of glucose regulation. Compared with placebo at 24 weeks, 2-h FFAs post-OGTT increased (mean difference, +20.4 mu mol/l; P < 0.05), and fasting glucose, 2-h glucose post-OGTT, and glucose area under the concentration-time curve (AUC) decreased with DAPA + ExQW [mean differences, -0.68 mmol/l [P < 0.001], -2.20 mmol/l (P < 0.01), and -306 mmol/l min (P < 0.001), respectively]. Glucagon, glycerol, beta-OH-butyrate, and IGI did not differ by treatment group at 24 weeks. Over 52 weeks, DAPA + ExQW decreased fasting insulin, 2-h post-OGTT insulin, and insulin AUC. Among DAPA + ExQW-treated participants, for each copy of the SNP variant rs10010131 A allele (gene WFS1), bodyweight decreased by 2.4 kg (P < 0.05). Lower BMI and a lower IGI were also associated with greater bodyweight loss with DAPA + ExQW. Metabolic effects with DAPA + ExQW included less FFA suppression versus placebo during the OGTT, suggesting compensatory lipid mobilization for energy production when glucose availability was reduced because of glucosuria. The expected increase in glucagon with DAPA did not occur with DAPA + ExQW coadministration. Bodyweight loss with DAPA + ExQW was associated with the SNP variant rs10010131 A allele, lower baseline adiposity (BMI), and lower baseline insulin secretion (IGI). These findings require further validation. AstraZeneca.
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| 38. |
- Pettus, J., et al.
(författare)
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Rates of Hypoglycemia Predicted in Patients with Type 2 Diabetes on Insulin Glargine 300 U/ml Versus First- and Second-Generation Basal Insulin Analogs: The Real-World LIGHTNING Study
- 2019
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Ingår i: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 10:2, s. 617-633
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionThe LIGHTNING study applied conventional and advanced analytic approaches to model, predict, and compare hypoglycemia rates of people with type 2 diabetes (T2DM) on insulin glargine 300 U/ml (Gla-300) with those on first-generation (insulin glargine 100 U/ml [Gla-100]; insulin detemir [IDet]) or second-generation (insulin degludec [IDeg]) basal-insulin (BI) analogs, utilizing a large real-world database.MethodsData were collected between 1 January 2007 and 31 March 2017 from the Optum Humedica US electronic health records [EHR] database. Patient-treatments, the period during which a patient used a specific BI, were analyzed for patients who switched from a prior BI or those who newly initiated BI therapy. Data were analyzed using two approaches: propensity score matching (PSM) and a predictive modeling approach using machine learning.ResultsA total of 831,456 patients with T2DM receiving BI were included from the EHR data set. Following selection, 198,198 patient-treatments were available for predictive modeling. The analysis showed that rates of severe hypoglycemia (using a modified definition) were approximately 50% lower with Gla-300 than with Gla-100 or IDet in insulin-naive individuals, and 30% lower versus IDet in BI switchers (all p<0.05). Similar rates of severe hypoglycemia were predicted for Gla-300 and IDeg, regardless of prior insulin experience. Similar results to those observed in the overall cohorts were seen in analyses across subgroups at a particularly high risk of hypoglycemia.PSM (performed on 157,573 patient-treatments) revealed comparable reductions in HbA(1c) with Gla-300 versus first- and second-generation BI analogs, alongside lower rates of severe hypoglycemia with Gla-300 versus first-generation BI analogs (p<0.05) and similar rates versus IDeg in insulin-naive and BI-switcher cohorts.ConclusionsBased on real-world data, predicted rates of severe hypoglycemia with Gla-300 tended to be lower versus first-generation BI analogs and similar versus IDeg in a wide spectrum of patients with T2DM.FundingSanofi, Paris, France.
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| 39. |
- Sharif, Ali, 1986-, et al.
(författare)
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Screening for Diabetic Retinopathy with Extended Intervals, Safe and Without Compromising Adherence : A Retrospective Cohort Study
- 2021
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Ingår i: Diabetes Therapy. - : Springer. - 1869-6953 .- 1869-6961. ; 12:1, s. 223-234
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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.
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| 40. |
- Sofizadeh, Sheyda, et al.
(författare)
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Effect of Liraglutide on Times in Glycaemic Ranges as Assessed by CGM for Type 2 Diabetes Patients Treated With Multiple Daily Insulin Injections
- 2019
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Ingår i: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 10:6, s. 2115-2130
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: The effects of the GLP-1 analogue liraglutide on time in hypoglycaemia, time in hyperglycaemia, and time in range for type 2 diabetes patients initially treated with multiple daily insulin injections (MDI) were investigated. Variables associated with hypoglycaemia in the current population were also identified. Methods: Analyses were based on data from a previously performed double-blind, placebo-controlled trial in which 124 MDI-treated patients with type 2 diabetes were randomized to liraglutide or placebo. Masked continuous glucose monitoring (CGM) was performed at baseline and week 24 in 99 participants. Results: The mean time in hypoglycaemia was similar for participants receiving liraglutide and those receiving placebo after 24 weeks of treatment. Mean time in target was greater in the liraglutide group than in the placebo group: 430 versus 244 min/24 h (p < 0.001) and 960 versus 695 min/24 h (p < 0.001) for the two glycaemic ranges considered, 4–7 mmol/l and 4–10 mmol/l, respectively. Mean time in hyperglycaemia was lower in the liraglutide group: 457 versus 723 min/24 h (p = 0.001) and 134 versus 264 min/24 h (p = 0.023) for the two cutoffs considered, > 10 mmol/l and > 14 mmol/l, respectively. Lower mean glucose level, lower C-peptide, and higher glucose variability were associated with an increased risk of hypoglycaemia in both treatment groups. Higher proinsulin level was associated with a lower risk of hypoglycaemia in the liraglutide group. Conclusion: For type 2 diabetes patients initially treated with MDI, introducing liraglutide had a beneficial effect on glucose profiles estimated by masked CGM. Mean glucose level, glycaemic variability, C-peptide, and proinsulin level influenced the risk of hypoglycaemia in this population. Trial Registration: ClinicalTrials.gov, number (EudraCT nr: 2012-001941-42). Funding: Novo Nordisk funded this study. The Diabetes Research Unit, NU-Hospital Group funded the journal’s Rapid Service Fee.
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| 41. |
- Stephen, Divya Anna, 1986-, et al.
(författare)
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Psychosocial Self-efficacy and its Association with Selected Potential Factors Among Adults with Type 1 Diabetes : A Cross-Sectional Survey Study
- 2024
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Ingår i: Diabetes Therapy. - : Springer. - 1869-6953 .- 1869-6961. ; 15:6, s. 1361-1373
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Tidskriftsartikel (refereegranskat)abstract
- Introduction The management of type 1 diabetes, a non-preventable chronic disease, leads to a high physical and psychological burden on the individual. Digital health technology can improve a person's psychosocial self-efficacy and thereby contribute to improved diabetes self-care. The aim of this study was to explore associations between psychosocial self-efficacy and demographic-, disease specific-, well-being as well as digital health technology (DHT) related factors among adults with type 1 diabetes.Methods A primarily web-based cross sectional survey was conducted among adults with type 1 diabetes in Sweden (n = 301). Psychosocial self-efficacy was assessed using the Swedish version of the Diabetes Empowerment Scale, Swe-DES-23. The survey also contained questions related to demographic-, disease specific-, well-being as well as digital health technology related variables.Results Higher well-being scores and lower HbA1c levels were associated with higher psychosocial self-efficacy in multiple linear regression analysis. In multivariate analysis, gender, body mass index, well-being scores, and HbA1c levels showed association with psychosocial self-efficacy. None of the DHT factors were found associated with psychosocial self-efficacy.Conclusions In this study, higher well-being score and lower self-reported HbA1c levels were associated with higher psychosocial self-efficacy in both univariate- and multivariate analysis and accounted for 30% of the variation in psychosocial self-efficacy in the regression model. Thus, measures to improve psychosocial self-efficacy in adults with type 1 diabetes may help maintain their psychological well-being and blood glucose control.
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| 42. |
- Svensson, Ann-Marie, 1961, et al.
(författare)
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Efficacy and Safety of Treatment with New Basal Insulin Analogues in Type 1 Diabetes: Nation-Wide Survey
- 2020
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Ingår i: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 11, s. 725-734
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Tidskriftsartikel (refereegranskat)abstract
- Introduction To date, only a few studies have addressed the long-term safety of basal insulins. We have therefore investigated the efficacy and safety of all available basal insulins used in the treatment of type 1 diabetes, using data from national databases in Sweden. Methods We assessed patients with type 1 diabetes who were using insulin glargine 100 U/mL (IG100) and who either continued using IG100 or switched to insulin glargine 300 U/mL (IG300) or insulin degludec (ID) for differences in clinical characteristics at baseline (index date) and subsequent changes in glycated haemoglobin (HbA1c), weight and hospitalizations caused by hypoglycaemia, cardiovascular disease or death. Results The mean follow-up time was 1.1 years for patients who switched to IG300 and ID and 1.6 years for those remaining on IG100. There were no marked differences in clinical characteristics between the groups, but patients on IG100 were slightly older and had used insulin pumps or continuous glucose monitors more seldom. The mean HbA1c levels were similar, and 4% of the patients had a history of cardiovascular disease. HbA1c decreased in all groups during follow-up, while the body mass index remained virtually unchanged. Rates of severe hypo- or hyperglycaemia were low and similar between the groups. Sixteen patients (0.7%) treated with IG300 and 13 patients (0.8%) treated with ID died during follow-up, while 221 patients (1.95%) on IG100 therapy died. All other severe adverse events were numerically more frequent in those patients receiving IG100, while there were no apparent differences between those receiving IG300 and those on ID. Conclusion The long-term effects and safety of IG300 and ID appear to be very similar in adult patients with type 1 diabetes. The results of this study suggest that these basal insulin analogues may provide benefits compared with the established reference IG100.
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| 43. |
- Wijk, Ingrid, et al.
(författare)
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Living with Type 1 Diabetes as Experienced by Adults with Prolonged Elevated HbA1c : A Qualitative Study
- 2023
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Ingår i: Diabetes Therapy. - : Springer Nature. - 1869-6953 .- 1869-6961. ; 14, s. 1673-1684
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: High HbA1c levels in type 1 diabetes (T1D) are associated with increased risk of micro- and macrovascular complications and severe diabetes distress. A more comprehensive understanding of the adult perspective of living with T1D can improve the quality of care. We aimed to describe experiences of living with T1D as an adult with prolonged elevated HbA1c.Methods: Thirteen adults with T1D and HbA1c > 60 mmol/mol (7.6%) for at least 1 year were individually interviewed via a digital platform. The interviews were transcribed verbatim and analyzed using qualitative content analysis.Results: The analysis identified an overarching theme, “a lifelong follower”, and generated two main categories describing study participants’ experience: constraining and manageable. Constraining experiences were explained in obligated control, loss of control, environmental impact, and consequences of diabetes. Manageable experiences were described in everyday life, approach to diabetes, and support in life. Diabetes knowledge in health care and in the general public, and individualized care were important factors in feeling understood, safe, and supported.Conclusions: The findings revealed the diverse experiences of adults with prolonged elevated HbA1c. Living with T1D, a lifelong non-chosen follower, could be perceived as constraining but manageable in different degrees. A person-centered care approach addressing both dimensions may be beneficial. Experiences of living with and managing diabetes are multifaceted and intertwined with life context and medical prerequisites.
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| 44. |
- Zhang, Yue, et al.
(författare)
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Prevalence and the association of body mass index and other risk factors with prediabetes and type 2 diabetes among 50,867 adults in China and Sweden: A cross-sectional study
- 2019
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Ingår i: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 10:6, s. 2061-2077
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Understanding socioeconomic differences for prediabetes and type 2 diabetes (T2DM) can offer guidance for the most effective development of both prevention and intervention programmes in different settings. This study aims to determine the prevalence and risk factors for prediabetes and T2DM and to explore the effect of high body mass index (BMI) on the probability of T2DM being present among adults in China and Sweden. Methods This study enrolled 25,356 adults (35-64 years old) from the Shanghai Survey in China and 25,511 adults (aged 40, 50, 60) from the Vasterbotten Intervention Programme in Sweden. Data on haemoglobin A1c, capillary fasting plasma glucose, 2-h plasma glucose and self-reported diagnoses of T2DM were used in the analysis. Multinomial logistic regression was used to examine the determinants of prediabetes and T2DM. The average predicted probabilities of T2DM developing or presenting were determined for the different ages and levels of BMI in each population. Results Chinese participants had a higher adjusted prevalence of T2DM (men 12.8% vs. 4.6%; women 10.6% vs. 3.1%) and prediabetes (men 12.4% vs. 12.2%; women 14.4% vs. 12.2%) than Swedish participants. Age, overweightedness/obesity, hypertension and a family history of diabetes were significant risk factors for prediabetes and T2DM. In both populations, the predicted probability of T2DM increased as the BMI increased in all age groups. At the same BMI level, Chinese participants were more likely to have T2DM compared to their Swedish counterparts. The average predicted probability of T2DM was less than 20% in nearly all age groups among Swedish women. Conclusions Chinese adults had the higher prevalence of prediabetes and T2DM and a higher probability of T2DM at the same BMI level compared with Swedish adults. These results indicate the importance of addressing the ongoing obesity epidemic as a matter of urgency in order to curb what has become an apparent diabetes epidemic in both countries.
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| 47. |
- Steen Carlsson, Katarina, et al.
(författare)
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Atherosclerotic Cardiovascular Disease in Type 2 Diabetes : A Retrospective, Observational Study of Economic and Clinical Burden in Sweden
- 2023
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Ingår i: Diabetes Therapy. - 1869-6953. ; 14:8, s. 1357-1372
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Individuals with type 2 diabetes (T2D) are at high risk of experiencing atherosclerotic cardiovascular disease (ASCVD), which is associated with morbidity, mortality and healthcare resource utilisation. Clinical guidelines recommend the use of glucose-lowering medications with cardiovascular benefits in individuals with T2D and cardiovascular disease, but there is evidence that this is not reflected in clinical practice. We used linked national registry data from Sweden to compare outcomes in people with T2D and ASCVD against matched controls with T2D without ASCVD, over 5 years. Direct costs (inpatient, outpatient and selected drug costs), indirect costs resulting from work absence, early retirement, cardiovascular events and mortality were examined. Methods: Individuals with T2D who were at least 16 years old and were alive and resident in Sweden on 1 January 2012 were identified in an existing database. In four separate analyses, individuals with a record indicating ASCVD according to a broad definition, peripheral artery disease (PAD), stroke or myocardial infarction (MI) before 1 January 2012 were identified using diagnosis and/or procedure codes and propensity score matched 1:1 to controls with T2D and without ASCVD, using covariates for birth, sex and level of education in 2012. Follow-up continued until death, migration from Sweden or the end of the study period in 2016. Results: In total, 80,305 individuals with ASCVD, 15,397 individuals with PAD, 17,539 individuals with previous stroke and 25,729 individuals with previous MI were included. Total mean annual costs per person were €14,785 for PAD (2.7 × costs for controls), €11,397 for previous stroke (2.2 × controls), €10,730 for ASCVD (1.9 × controls) and €10,342 for previous MI (1.7 × controls). Indirect costs and costs of inpatient care were the major cost drivers. ASCVD, PAD, stroke and MI were all associated with an increased likelihood of early retirement, cardiovascular events and mortality. Conclusions: ASCVD is associated with considerable costs, morbidity and mortality in individuals with T2D. These results support structured assessment of ASCVD risk and broader implementation of guideline-recommended treatments in T2D healthcare.
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