| 1. |
- Adolfsson, Peter, 1963, et al.
(author)
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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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In: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 13, s. 43-56
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Journal article (peer-reviewed)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. |
- Bernfort, Lars, et al.
(author)
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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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In: Diabetes Therapy. - : SPRINGER HEIDELBERG. - 1869-6953 .- 1869-6961. ; 11:7, s. 1537-1549
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Journal article (peer-reviewed)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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| 3. |
- Bernfort, Lars, et al.
(author)
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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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In: Diabetes Therapy. - : Springer Berlin/Heidelberg. - 1869-6953 .- 1869-6961. ; 11, s. 2921-2930
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Journal article (peer-reviewed)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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| 4. |
- Blissett, D. B., et al.
(author)
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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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In: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 12:8, s. 2179-2193
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Journal article (peer-reviewed)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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| 5. |
- Cederblad, Lars, et al.
(author)
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Classification of Hypoglycemic Events in Type 1 Diabetes Using Machine Learning Algorithms
- 2023
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In: Diabetes Therapy. - : Springer Nature. - 1869-6953 .- 1869-6961. ; 14:6, s. 953-965
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Journal article (peer-reviewed)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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| 6. |
- de Valk, Harold W., et al.
(author)
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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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In: Diabetes Therapy. - : Springer. - 1869-6953 .- 1869-6961. ; 11:9, s. 2159-2167
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Journal article (peer-reviewed)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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| 7. |
- Dena, Mary, et al.
(author)
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Renal Complications and Duration of Diabetes: An International Comparison in Persons with Type 1 Diabetes
- 2021
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In: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; :12, s. 3093-3105
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Journal article (peer-reviewed)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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| 8. |
- Dwibedi, Chinmay, 1987, et al.
(author)
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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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In: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 13, s. 423-439
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Journal article (peer-reviewed)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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| 9. |
- Eliasson, Bjoern, et al.
(author)
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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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In: DIABETES THERAPY. - 1869-6953 .- 1869-6961. ; 15:6, s. 1301-1312
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Journal article (peer-reviewed)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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| 10. |
- Eliasson, Björn, 1959, et al.
(author)
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Persistence with IDegLira in Patients in Clinical Practice: A Nationwide Observational Study in Sweden
- 2020
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In: Diabetes Therapy. - : Springer Science and Business Media LLC. - 1869-6953 .- 1869-6961. ; 11, s. 1807-1820
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Journal article (peer-reviewed)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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