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.

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.

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.