Evaluation of hybrid closed-loop insulin delivery system in type 1 diabetes in real-world clinical practice: One-year observational study.

BACKGROUND: In 2016, the Food and Drug Administration approved the first hybrid closed-loop (HCL) insulin delivery system for adults with type 1 diabetes (T1D). There is limited information on the impact of using HCL systems on patient-reported outcomes (PROs) in patients with T1D in real-world clinical practice. In this independent study, we evaluated glycemic parameters and PROs over one year of continuous use of Medtronic's 670G HCL in real-world clinical practice. AIM: To assess the effects of hybrid closed loop system on glycemic control and quality of life in adults with T1D. METHODS: We evaluated 71 patients with T1D (mean age: 45.5 ± 12.1 years; 59% females; body weight: 83.8 ± 18.7 kg, body mass index: 28.7 ± 5.6 kg/m2, A1C: 7.6% ± 0.8%) who were treated with HCL at Joslin Clinic from 2017 to 2019. We measured A1C and percent of glucose time-in-range (%TIR) at baseline and 12 months. We measured percent time in auto mode (%TiAM) for the last two weeks preceding the final visit and assessed PROs through several validated quality-of-life surveys related to general health and diabetes management. RESULTS: At 12 mo, A1C decreased by 0.3% ± 0.1% (P = 0.001) and %TIR increased by 8.1% ± 2.5% (P = 0.002). The average %TiAM was only 64.3% ± 32.8% and was not associated with A1C, %TIR or PROs. PROs, provided at baseline and at the end of the study, showed that the physical functioning submodule of 36Item Short-Form Health Survey increased significantly by 22.9% (P < 0.001). Hypoglycemia fear survey/worry scale decreased significantly by 24.9% (P < 0.000); Problem Areas In Diabetes reduced significantly by -17.2% (P = 0.002). The emotional burden submodules of dietary diversity score reduced significantly by -44.7% (P = 0.001). Furthermore, analysis of Clarke questionnaire showed no increase in awareness of hypoglycemic episodes. WHO-5 showed no improvements in subject's wellbeing among participants after starting the 670G HCL system. Finally, analysis of Pittsburgh Sleep Quality Index showed no difference in sleep quality, sleep latency, or duration of sleep from baseline to 12 mo. CONCLUSION: The use of HCL in real-world clinical practice for one year was associated with significant improvements in A1C, %TIR, physical functioning, hypoglycemia fear, emotional distress, and emotional burden related to diabetes management. However, these changes were not associated with time in auto mode.

Long-term effect of intensive lifestyle intervention on cardiometabolic risk factors and microvascular complications in patients with diabetes in real-world clinical practice: a 10-year longitudinal study.

INTRODUCTION: Intensive lifestyle intervention (ILI) has significantly reduced incidence of diabetes and improved many cardiovascular disease risk factors. We evaluated long-term effects of ILI on cardiometabolic risk factors, and microvascular and macrovascular complications among patients with diabetes in real-world clinical practice. RESEARCH DESIGN AND METHODS: We evaluated 129 patients with diabetes and obesity enrolled in a 12-week translational model of ILI. At 1 year, we divided participants into group A, who maintained <7% weight loss (n=61, 47.7%), and group B, who maintained ≥7% weight loss (n=67, 52.3%). We continued to follow them for 10 years. RESULTS: The total cohort lost an average of 10.8±4.6 kg (-9.7%) at 12 weeks and maintained an average weight loss of 7.7±10 kg (-6.9%) at 10 years. Group A maintained 4.3±9.5 kg (-4.3%) and group B maintained 10.8±9.3 kg (-9.3%) of weight loss at 10 years (p<0.001 between groups). In group A, A1c decreased from 7.5±1.3% to 6.7±0.9% at 12 weeks but rebounded to 7.7±1.4% at 1 year and 8.0±1.9% at 10 years. In group B, A1c decreased from 7.4±1.2% to 6.4±0.9% at 12 weeks then increased to 6.8±1.2% at 1 year and 7.3±1.5% at 10 years (p<0.05 between groups). Maintenance of ≥7% weight loss at 1 year was associated with a 68% lower risk of developing nephropathy for up to 10 years compared with maintenance of <7% weight loss (adjusted HR for group B: 0.32, 95% CI 0.11, 0.9, p=0.007). CONCLUSIONS: Weight reduction in patients with diabetes can be maintained for up to 10 years in real-world clinical practice. Sustained weight loss is associated with significantly lower A1c at 10 years and improvement in lipid profile. Maintenance of ≥7% weight loss at 1 year is associated with decreased incidence of diabetic nephropathy at 10 years.

Magnitude of A1C improvement in relation to baseline A1C and amount of weight loss in response to intensive lifestyle intervention in real-world diabetes practice: 13 years of observation.

BACKGROUND: Effect of intensive lifestyle intervention (ILI) on A1C in participants with diabetes is underestimated. A1C improvement is presumed to be dependent on the amount of weight loss. Here, we evaluate the magnitude of A1C change in relation to baseline A1C and the amount of weight loss in participants with diabetes who underwent ILI over 13 years in real-world clinical practice. METHODS: A total of 590 participants with diabetes were enrolled in the Weight Achievement and Intensive Treatment (Why WAIT) program, a 12-week multidisciplinary ILI program designed for real-world clinical practice between September 2005 and May 2018. We stratified participants based on baseline A1C into three groups: group A: A1C ≥ 9%, group B: A1C 8 to <9%, and group C: A1C ≥6.5% to <8%. RESULTS: After 12-weeks of intervention, body weight decreased in all groups, and pairwise comparisons of A1C changes showed that: group A had 1.3% greater A1C reduction than group B (p = 0.0001) and 2% greater than group C (p = 0.0001), while group B had 0.7% greater A1C reduction than group C (p = 0.0001). CONCLUSION: We conclude that ILI may decrease A1C by up to 2.5% in participants with diabetes. At similar magnitude of weight loss, A1C reduction was more prominent in participants with higher baseline A1C. This may be valuable for clinicians to set a realistic expectation of A1C change in response to ILI.

Multidisciplinary intensive lifestyle intervention improves markers of nonalcoholic fatty liver disease (NAFLD) in patients with type 1 diabetes and obesity: a retrospective matched-cohort study.

BACKGROUND: The prevalence of non-alcoholic fatty liver disease (NAFLD) is increasing among patients with type 1 diabetes (T1D) paralleling the increasing prevalence of obesity among this population. However, little is known about the impact of intensive lifestyle intervention (ILI) on NAFLD in patients with T1D. METHODS: Using Hepatic Steatosis Index (HSI), a noninvasive surrogate predictor of NAFLD, we retrospectively evaluated 88 adult patients with T1D and obesity after one year of participating in a 12-week ILI program in real-world clinical practice. Using the NAFLD guidelines of the American Association for the Study of Liver Diseases (AASLD), we excluded 11 participants. We matched the remaining ILI cohort (age 43 ± 12 years, females 65%, diabetes duration 22 ± 9 years, A1C 8.2 ± 0.9%, body weight 101 ± 17 kg, BMI 35.3 ± 4.9 kg/m2) in 1:1 ratio with a similar cohort of patients with T1D and obesity who received standard diabetes care (SC) at the same practice and during the same period. Matching criteria included: sex, age, BMI, A1C and duration of T1D. HSI [8 + ALT/AST + BMI (+ 2 if female, + 2 if T2D)] was calculated at baseline and after 12 months of intervention. RESULTS: At baseline, HSI was similar between the two cohorts (46.2 ± 6.1 in the ILI cohort and 44.9 ± 5.7 in the SC cohort). After 12 months, the ILI group lost an average of 5.6 ± 2.7 kg (5.8%, p < 0.05) while the SC group maintained their baseline body weight (p < 0.001 between groups). HSI decreased significantly from baseline in the ILI group (-2.7 ± 1.1, p = 0.01), but did not change in the SC group (0.6 ± 0.9, p = 0.53, p < 0.001 between groups). Percentage of patients with high likelihood of NAFLD diagnosis decreased from 100% at baseline to 88.3% in the ILI group, and was 10.4% less compared to SC (p < 0.01). Total daily insulin dose decreased in the ILI cohort compared to the SC cohort (-6.1 ± 4.2 versus 1.34 ± 4.3 units/day, p < 0.01). CONCLUSIONS: Twelve weeks of ILI improved HSI and decreased total daily insulin requirements in patients with T1D and obesity at one year. Short-term ILI should be implemented in the management of NAFLD for obese patients with type 1 diabetes.

In-person and virtual multidisciplinary intensive lifestyle interventions are equally effective in patients with type 2 diabetes and obesity.

Background: Intensive lifestyle intervention (ILI) is essential for diabetes management. The Weight Achievement and Intensive Treatment (Why WAIT) program is a 12-week multidisciplinary weight management program that has been implemented in real-world clinical practice since 2005 and has shown long-term maintenance of weight reduction for 5 and 10 years. During the COVID-19 pandemic, the program went virtual using telemedicine and mobile health applications. Aims: This retrospective pilot study aims to evaluate the effectiveness of a virtual model of an already established and successful in-person program for diabetes and weight management since 2005. Methods: We evaluated 38 patients with diabetes and obesity enrolled in the Why WAIT program between February 2019 and December 2020. Sixteen participants were enrolled in virtual program (VP) and were compared with 22 participants who completed the latest two physical programs (PPs) before COVID-19. We evaluated changes in body weight, A1C, blood pressure (BP), and lipid profile after 12 weeks of ILI. Results: Body weight decreased by -7.4 ± 3.6 kg from baseline in VP compared with -6.8 ± 3.5 kg in PP (p = 0.6 between groups). A1C decreased by -1.03% ± 1.1% from baseline in VP, and by -1.0% ± 1.2% in PP (p = 0.9 between groups). BP, lipid profile, and all other parameters improved in both groups with no significant difference between them. Conclusion: Virtual multidisciplinary ILI is as effective as the in-person intervention program in improving body weight, A1C, BP, and lipid profile, and in reducing the number of anti-hyperglycemic medications. Results from our study suggest that scaling the Why WAIT program in a virtual format to a larger population of patients with diabetes and obesity is feasible and is potentially as successful as the in-person program.

Hybrid model of intensive lifestyle intervention is potentially effective in patients with diabetes & obesity for post-COVID era.

The Weight Achievement and Intensive Treatment (Why WAIT) program is a 12-week multidisciplinary intensive lifestyle intervention (ILI) for patients with diabetes and obesity in real-world clinical practice that has led to long-term weight loss maintenance for up to 10 years. During COVID-19, we reported that a virtual model (VM) of the program was equally effective in reducing body weight and improving glycemic control. Here, we test a newly-introduced hybrid model (HM), to accommodate ongoing restrictions of the pandemic. We evaluated 56 participants: 18 from HM, 16 from VM and 22 from the in-person model (iPM). At 12 weeks, mean change in body weight from baseline for HM was -8.2 ± 5.0 kg; p<0.001. Mean change in A1C for HM was -0.6 ± 0.6%; p=0.002. There were no significant differences in body weight reduction (p=0.7) or A1C reduction (p=0.6) between groups. Blood pressure, lipid profile, and all other parameters showed improvements without significant differences between groups. Overall, HM is as effective as VM and iPM in reducing body weight and A1C after 12 weeks. Given its scalability, HM could be offered to more patients with diabetes and obesity who may benefit from its increased flexibility and enhanced accountability without compromising the multidisciplinary approach for a post-COVID era.