| 1. |
- Da Silva, Julien, et al.
(författare)
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Real-world performance of the MiniMed™ 670G system in Europe
- 2021
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Ingår i: Diabetes, obesity and metabolism. - : Wiley-Blackwell Publishing Inc.. - 1462-8902 .- 1463-1326. ; 23:8, s. 1942-1949
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: The MiniMed™ 670G system has been available in Europe since October 2018. Herein, the system's real-world performance in individuals with diabetes is evaluated.MATERIALS AND METHODS: Data uploaded October 2018 to July 2020 by individuals living in Europe were aggregated and retrospectively analyzed. The mean Glucose Management Indicator (GMI), percentage of time spent within (TIR), below (TBR) and above (TAR) glycemic ranges, system use and insulin consumed in users with ≥10 days of SG data after initial Auto Mode start were determined. Another analysis based on suboptimally- (GMI >8.0%) and well-controlled (GMI <7.0%) glycemia pre-Auto Mode initiation was also performed.RESULTS: Users (N=14,899) spent a mean of 81.4% of the time in Auto Mode and achieved a mean GMI of 7.0±0.4%, TIR of 72.0±9.7%, TBR <3.9 mmol/L of 2.4±2.1% and TAR >10 mmol/L of 25.7±10%, after initiating Auto Mode. When compared to pre-Auto Mode initiation, GMI reduced by 0.3±0.4% and TIR increased by 9.6±9.9% (p<0.0001 for both). Significantly improved glycemic control was observed irrespectively of pre-Auto Mode GMI level <7.0% or >8.0%. While total daily dose of insulin increased for both groups, a greater increase was observed in the latter: an increase due primarily to increased basal insulin delivery. In contrast, basal insulin decreased slightly in well-controlled users.CONCLUSIONS: Most MiniMed™ 670G system users in Europe achieved TIR >70% and GMI <7% while minimizing hypoglycemia, in a real-world environment. These international consensus-met outcomes were enabled by automated insulin delivery meeting real-time insulin requirements adapted to each individual user.
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| 2. |
- Hellman, Jarl, et al.
(författare)
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Associations of bolus insulin injection frequency and smart pen engagement with glycaemic control in people living with type 1 diabetes
- 2024
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Ingår i: Diabetes, obesity and metabolism. - : John Wiley & Sons. - 1462-8902 .- 1463-1326. ; 26:1, s. 301-310
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Tidskriftsartikel (refereegranskat)abstract
- AimTo evaluate whether both bolus insulin injection frequency and smart pen engagement were associated with changes in glycaemic control, using real-world data from adults with type 1 diabetes (T1D).Materials and MethodsAdults using a smart pen (NovoPen 6) to administer bolus insulin (fast-acting insulin aspart or insulin aspart) alongside continuous glucose monitoring were eligible for inclusion. Smart pen engagement was characterized by number of days with pen data uploads over the previous 14 days. Glycaemic control was evaluated by analysing glucose metrics.ResultsOverall, data from 1194 individuals were analysed. The number of daily bolus injections was significantly associated with time in range (TIR; 3.9-10.0 mmol/L [70-180 mg/dL]; P < 0.0001). Individuals administering, on average, three daily bolus insulin injections had an estimated 11% chance of achieving >70% TIR. The probability of achieving >70% TIR increased with the mean number of daily bolus injections. However, the percentage of TIR was lower on days when individuals administered higher-than-average numbers of injections. The observed mean number of daily bolus injections administered across the study population was lower than the optimal number required to reach glycaemic targets (4.8 injections vs. 6-8 injections). Smart pen engagement was significantly associated with improved TIR.ConclusionsGlycaemic control was associated with daily bolus insulin injection frequency and smart pen engagement. A treatment regimen combining an optimal bolus injection strategy, and effective smart pen engagement, may improve glycaemic control among adults with T1D.
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| 3. |
- Jendle, Johan, 1963-, et al.
(författare)
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Continuous glucose monitoring in patients with type 2 diabetes treated with glucagon-like peptide-1 receptor agonist dulaglutide in combination with prandial insulin lispro : an AWARD-4 substudy
- 2016
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Ingår i: Diabetes, obesity and metabolism. - : Wiley-Blackwell Publishing Inc.. - 1462-8902 .- 1463-1326. ; 18:10, s. 999-1005
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Tidskriftsartikel (refereegranskat)abstract
- Background: Insulin use with GLP-1 receptor agonists is of interest because of the potential for glucose lowering with reduced insulin dosing versus an insulin-only regimen. The AWARD-4 trial, designed to compare these regimens, included a sub-study using 24-hour continuous glucose monitoring (CGM).Methods: The AWARD-4 trial randomised 884 conventional insulin regimens-treated patients to dulaglutide 1.5 mg, 0.75 mg and glargine, all in combination with prandial insulin lispro. The CGM sub-study included 144 patients inserted with Medtronic CGMS® iPro™ CGM device to enable 3-day glucose monitoring. CGM sessions were completed at weeks 0, 13, 26, and 52. CGM measures included mean 24-hour glucose, percentage time in target glucose ranges, hyper- and hypoglycaemia, and glucose variability. The primary objective was treatment comparison for percentage time CGM glucose in the 3.9-7.8 mmol/L range after 26 weeks.Results: At week 26, mean CGM glucose decreased in all treatment groups (change from baseline -2.8 ± 0.3, -2.4 ± 0.3, and -2.5 ± 0.3 mmol/L for dulaglutide 1.5 mg, 0.75 mg, and glargine, respectively); between-group differences were not statistically significant. Treatment groups were similar for percentage time in 3.9-7.8 mmol/L range. Percentage time in 3.9-10.0 mmol/L range was greater for dulaglutide 1.5 mg than glargine (p < 0.05). Dulaglutide and glargine were associated with decreased glucose variability for all CGM variability indices. Overall within-patient SD was significantly reduced with dulaglutide 1.5 mg versus glargine (p < 0.05). At week 52, there were no significant differences between groups for measures of normoglycaemia or near-normoglycaemia and for the overall within-patient SD. Treatment with glargine was associated with greater increases in percentage time glucose was ≤3.9 mmol/L with statistically significant differences between the groups at 52 weeks (p < 0.05).Conclusions: In combination with prandial lispro, treatment with dulaglutide and glargine resulted in similar proportions of glucose values in the normoglycaemic range, but dulaglutide provided an improved balance between the proportion of values within the near-normoglycaemia range and values within the hypoglycaemic range.
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| 4. |
- Jendle, Johan, 1963-, et al.
(författare)
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Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials
- 2019
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Ingår i: Diabetes, obesity and metabolism. - : John Wiley & Sons. - 1462-8902 .- 1463-1326. ; 21:10, s. 2315-2326
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Tidskriftsartikel (refereegranskat)abstract
- AIM: To investigate treatment satisfaction with semaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, versus placebo/active comparators in theSUSTAIN clinical trial programme.METHODS: In SUSTAIN 2-5 and 7, the Diabetes Treatment Satisfaction Questionnaire was used to evaluate patient-perceived treatment satisfaction, hyperglycaemia and hypoglycaemia. Post hoc subgroup analyses were conducted to explore the effects of gastrointestinal adverse events (GI AEs), weight loss (>= 5%) or achieving glycaemic (HbA1c < 7%) targets on treatment satisfaction.RESULTS: Overall treatment satisfaction increased from baseline to end of treatment with all treatments across trials. Improvements were significantly greater with semaglutide versus comparators/placebo in SUSTAIN 2-5 (all P < 0.05), and generally greater in patients who achieved versus did not achieve weight loss and glycaemic targets, often with greater improvements with semaglutide 1.0 mg versus comparator/placebo in both weight loss groups. In SUSTAIN 7, improvements in overall treatment satisfaction were generally similar between semaglutide and dulaglutide, irrespective of weight loss or glycaemic control. In SUSTAIN 7, changes in overall treatment satisfaction score were generally lower in patients with versus without GI AEs at week 16 (except dulaglutide 0.75 mg), but similar by week 40. Perceived hyperglycaemia was significantly reduced from baseline to end of treatment with semaglutide versus all comparators/placebo (all P < 0.05). No differences between treatments were observed for perceived hypoglycaemia.CONCLUSIONS: Semaglutide was associated with significantly greater (SUSTAIN 2-5) or similar (SUSTAIN 7) improvements in overall treatment satisfaction versus comparators/placebo. Improvements in overall treatment satisfaction were generally greater in patients achieving versus not achieving treatment targets. Clinicaltrials.gov: NCT01930188 (SUSTAIN 2), NCT01885208 (SUSTAIN 3), NCT02128932 (SUSTAIN 4), NCT02305381 (SUSTAIN 5) and NCT02648204 (SUSTAIN 7). EudraCT: 2012-004827-19 (SUSTAIN 2), 2012-004826-92 (SUSTAIN 3), 2013-004392-12 (SUSTAIN 4), 2013-004502-26 (SUSTAIN 5) and 2014-005375-91 (SUSTAIN 7).
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| 5. |
- Jendle, Johan, 1963-, et al.
(författare)
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Use of insulin pumps and closed-loop systems among people living with diabetes : A narrative review of clinical and cost-effectiveness to enable access to technology and meet the needs of payers
- 2023
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Ingår i: Diabetes, obesity and metabolism. - : Wiley-Blackwell Publishing Inc.. - 1462-8902 .- 1463-1326. ; 25:Sup. 2, s. 21-32
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Forskningsöversikt (refereegranskat)abstract
- The use of continuous subcutaneous insulin infusion delivery via insulin pumps is today considered standard of care for type 1 diabetes (T1D). Closed-loop systems combining continuous glucose monitoring (CGM) with automated algorithm-driven insulin delivery have been shown to be safe and efficacious in randomized controlled studies and in real-life studies in both pediatric and adult individuals with T1D. Implementation of hybrid closed-loop (HCL) systems have shown incremental effectiveness with further reduction of hypoglycemia and hyperglycemia. Although less extensively studied in type 2 diabetes (T2D), insulin pumps have demonstrated their effectiveness on glucose control together with the reduction in insulin needs and a neutral effect on weight. Recent studies have also shown promising results with the use of HCL in T2D. Cost-effectiveness studies both in T1D and T2D have shown that pump is cost effective in several countries, leading to improvements in quality adjusted life years. Insulin pumps are currently reimbursed for T1D in many European countries, but only in a few for individuals with T2D. HCL systems are to be evaluated in future trials performed in T2D to compare their incremental efficacy and cost effectiveness in comparison with available intensification tools which include multiple daily insulin injections, metformin, SGLT-2 inhibitors and GLP-1 receptor agonists. There is a need for updated guidelines for the use of CSII and HCL in individuals living with T2D based on the emerging evidence, identifying, and recommending for the people who'd benefit the most, which would eventually form a basis for the reimbursement and health policies.
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| 6. |
- Jendle, Johan, et al.
(författare)
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Weight loss with liraglutide, a once-daily human glucagon-like peptide-1 analogue for type 2 diabetes treatment as monotherapy or added to metformin, is primarily as a result of a reduction in fat tissue
- 2009
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Ingår i: Diabetes, obesity and metabolism. - : Wiley. - 1462-8902 .- 1463-1326. ; 11:12, s. 1163-1172
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Tidskriftsartikel (refereegranskat)abstract
- Aim The effect on body composition of liraglutide, a once-daily human glucagon-like peptide-1 analogue, as monotherapy or added to metformin was examined in patients with type 2 diabetes (T2D). Methods These were randomized, double-blind, parallel-group trials of 26 [Liraglutide Effect and Action in Diabetes-2 (LEAD-2)] and 52 weeks (LEAD-3). Patients with T2D, aged 18-80 years, body mass index (BMI) < 40 kg/m2 (LEAD-2), < 45 kg/m2 (LEAD-3) and HbA1c 7.0-11.0% were included. Patients were randomized to liraglutide 1.8, 1.2 or 0.6 mg/day, placebo or glimepiride 4 mg/day, all combined with metformin 1.5-2 g/day in LEAD-2 and to liraglutide 1.8, 1.2 or glimepiride 8 mg/day in LEAD-3. LEAD-2/3: total lean body tissue, fat tissue and fat percentage were measured. LEAD-2: adipose tissue area and hepatic steatosis were assessed. Results LEAD-2: fat percentage with liraglutide 1.2 and 1.8 mg/metformin was significantly reduced vs. glimepiride/metformin (p < 0.05) but not vs. placebo. Visceral and subcutaneous adipose tissue areas were reduced from baseline in all liraglutide/metformin arms. Except with liraglutide 0.6 mg/metformin, reductions were significantly different vs. changes seen with glimepiride (p < 0.05) but not with placebo. Liver-to-spleen attenuation ratio increased with liraglutide 1.8 mg/metformin possibly indicating reduced hepatic steatosis. LEAD-3: reductions in fat mass and fat percentage with liraglutide monotherapy were significantly different vs. increases with glimepiride (p < 0.01). Conclusion Liraglutide (monotherapy or added to metformin) significantly reduced fat mass and fat percentage vs. glimepiride in patients with T2D.
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| 7. |
- Lindblad, Ulf, 1950, et al.
(författare)
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Can sulphonylurea addition to lifestyle changes help to delay diabetes development in subjects with impaired fasting glucose? The Nepi ANtidiabetes StudY (NANSY)
- 2011
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Ingår i: Diabetes, Obesity and Metabolism. - Malden,USA : Wiley. - 1462-8902 .- 1463-1326. ; 13:2, s. 185-188
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Tidskriftsartikel (refereegranskat)abstract
- The Nepi ANtidiabetes StudY (NANSY) is a 5-year randomized, double-blind, placebo-controlled trial in Swedish primary care, examining whether the development of type 2 diabetes (T2D) and retinopathy (separately reported) would be delayed in 40- to 70-year-old subjects with impaired fasting glucose (IFG) who, in addition to lifestyle changes, were treated with either placebo or low-dosage sulphonylurea (SU) (1-mg glimepiride; Amaryl (R)). Of 274 subjects (163 men, 111 women), 138 were allocated to placebo (46.0% men, 56.8% women) and 136 to glimepiride (54.0% men, 43.2% women). The primary endpoint was conversion to diabetes. Average follow-up time was 3.71 years; 96 subjects converted to diabetes, 55 allocated to placebo and 41 to glimepiride (absolute difference 9.8%; p = 0.072). In conclusion, the study failed to support the notion that low-dose SU added to lifestyle changes in IFG subjects would help to delay the conversion to diabetes.
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| 8. |
- Nilsson, Kristoffer, et al.
(författare)
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Model-based predictions on health benefits and budget impact of implementing empagliflozin in people with type 2 diabetes and established cardiovascular disease
- 2023
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Ingår i: Diabetes, obesity and metabolism. - : Wiley-Blackwell Publishing Inc.. - 1462-8902 .- 1463-1326. ; 25:3, s. 748-757
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Tidskriftsartikel (refereegranskat)abstract
- AIM: To perform a model-based analysis of the short- and long-term health benefits and costs of further increased implementation of empagliflozin for people with type 2 diabetes and established cardiovascular disease (eCVD) in Sweden.MATERIALS AND METHODS: The validated Institute for Health Economics Diabetes Cohort Model (IHE-DCM) was used to estimate health benefits and 3-years' budget impact, and lifetime costs per quality-adjusted life year (QALY) gained of increased implementation of adding empagliflozin to standard of care (SoC) for people with type 2 diabetes and eCVD in a Swedish setting. Scenarios with 100%/75%/50% implementation were explored. Analyses were based on 30 model cohorts with type 2 diabetes and eCVD (n=131,412 at baseline) from national health data registers. Sensitivity analyses explored the robustness of results.RESULTS: Over 3 years, SoC with empagliflozin (100% implementation) vs. SoC before empagliflozin resulted in 7,700 total life years gained and reductions in cumulative incidence of cardiovascular deaths by 30% and heart failures by 28%. Annual costs increased by 6% from higher treatment costs and increased survival. Half of these benefits and costs are not yet reached with current implementation below 50%. SoC with empagliflozin yielded 0.37 QALYs per person, with an incremental cost-effectiveness ratio of €16,000 EUR per QALY vs. SoC before empagliflozin.CONCLUSIONS: Model simulations using real-world data and trial treatment effects indicated that a broader implementation of empagliflozin, in line with current guidelines for treatment of people with type 2 diabetes and eCVD, would lead to further benefits even in a short-term perspective.
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| 9. |
- Persson, Sofie, et al.
(författare)
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Burden of established cardiovascular disease in people with type 2 diabetes and matched controls : Hospital-based care, days absent from work, costs, and mortality
- 2023
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Ingår i: Diabetes, obesity and metabolism. - : John Wiley & Sons. - 1462-8902 .- 1463-1326. ; 53:3, s. 726-734
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: To assess hospital-based care, work absence, associated costs, and mortality in type 2 diabetes with and without established cardiovascular disease (eCVD) compared to matched controls.METHODS: In a population-based cohort study, we analysed individual-level data from national health, social insurance, and socio-economic registers for people with type 2 diabetes diagnosis<70 years and controls (5:1) in Sweden. Regression analysis attributed costs and days absent to eCVD. Mortality was analysed using Cox proportional hazard regression stratified for birthyear and adjusted for sex and education.RESULTS: Thirty percent (n=136 135 of 454 983) of people with type 2 diabetes had ≥1 person-year with eCVD (women 24%; men 34%). The mean annual costs of hospital-based care for diabetes complications were EUR 2 629 (95% confidence interval [CI] 2 601 to 2 657) of which EUR 2 337 (95% CI 2 309 to 2 365) were attributed to eCVD (89%). The highest-costing person-years (10th percentile) were observed in a broad subgroup, 42% of people with type 2 diabetes and eCVD. People with type 2 diabetes had on average 146 days absent (95% CI 145-147) per year of which 68 days (47%; 95% CI 67-70) were attributed to eCVD. Mortality was increased in type 2 diabetes: eCVD hazard rate [HR] 4.63 (95% CI 4.58-4.68), no eCVD HR 1.86 (95% CI 1.84-1.88).CONCLUSIONS: The sizable burden of eCVD, on the individual with type 2 diabetes and the society, calls for efficient management for reducing the risks for those living with eCVD and postponing its onset. This article is protected by copyright. All rights reserved.
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| 10. |
- Persson, Sofie, et al.
(författare)
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Days absent from work as a result of complications associated with type 2 diabetes : Evidence from 20 years of linked national registry data in Sweden
- 2020
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Ingår i: Diabetes, Obesity and Metabolism. - : Wiley. - 1462-8902 .- 1463-1326. ; 22:9, s. 1586-1597
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Tidskriftsartikel (refereegranskat)abstract
- Aims: To analyse days absent from work related to individual microvascular, macrovascular and other complications of type 2 diabetes (T2D) and to identify key drivers of absence. Materials and methods: National health and socio-economic individual-level data were analysed for the years 1997 to 2016 for people with T2D, and age-, sex- and residential region-matched controls (5:1) using linkage to Swedish national administrative registers, based on personal identity numbers. Regression analyses accounting for individual-level clustering and education were estimated to obtain days absent by individual complications. Alternative analyses, for example, workforce indicator and age subgroups, were explored for robustness and comparison purposes. Results: A total of 413 000 people with T2D aged <66 years, comprising 4.9 million person-years, was included. The crude proportion with any absence was higher among those with T2D compared to controls (47% vs. 26%) in the index year, and the median (IQR) number of days was higher (223 [77;359] vs. 196 [59;352]) if any absence. Regression analyses showed that complications per se were a key driver of days absent: stroke (+102 days); end-stage renal disease (+70 days); severe vision loss (+56 days); and angina pectoris, heart failure, and osteoarthritis (+53 days each). The alternative analyses showed similar levels of days absent and age subgroups differed in expected directions. Conclusions: This study provides evidence of the persisting impact on productivity from complications that supports continued efforts to reduce risk factors in T2D. Future studies on burden of disease and economic evaluations of new therapies and disease management may use this new set of complication-specific estimates to improve understanding of the value of reducing complications.
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