Improved Glycemia and Quality of Life Among Loop Users: Analysis of Real-world Data From a Single Center

Abstract

Background Despite do-it-yourself automated insulin delivery being an unapproved method of insulin delivery, an increasing number of people with type 1 diabetes (T1D) worldwide are choosing to use Loop, a do-it-yourself automated insulin delivery system. Objective In this study, we aimed to assess glycemic outcomes, safety, and the perceived impact on quality of life (QOL) in a local Edmonton cohort of known Loop users. Methods An observational study of adults with T1D who used Loop was performed. An assessment of glycemic and safety outcomes, HbA1c, time in range, hospital admissions, and time below range compared users most recent 6 months of Loop use, with their prior regulatory approved insulin delivery method. QOL outcomes were assessed using Insulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations, diabetes impact, and device satisfaction measures (with maximum scores of 100, 10, and 10, respectively) and semistructured interviews. Results The 24 adults with T1D who took part in this study 16 (67%) were female, with a median age of 33 (IQR 28-45) years, median duration of diabetes of 22 (IQR 17-32) years, median pre-Loop HbA1c of 7.9% (IQR 7.6%-8.3%), and a median duration of Loop use of 18 (IQR 12-25) months. During Loop use, the participants had median (IQR) values of 7.1% (6.5%-7.5%), 54 mmol (48-58) for HbA1c and 76.5% (64.6%-81.9%) for time in range, which were a significant improvement from prior therapy (P=.001 and P=.005), with a nonsignificant reduction in time below range; 3.0 to 3.9 mmol/L (P=.17) and <3 mmol/L (P=.53). Overall, 2 episodes of diabetic ketoacidosis occurred in a total of 470 months of Loop use, and no severe hypoglycemia occurred. The positive impact of Loop use on QOL was explored in qualitative analysis and additionally demonstrated through a median Insulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations score of 86 (IQR 79-95), a median diabetes impact score of 2.8 (IQR 2.1-3.9), and a median device satisfaction score of 9 (IQR 8.2-9.4). Conclusions This local cohort of people with T1D demonstrated a beneficial effect of Loop use on both glycemic control and QOL, with no safety concerns being highlighted.

Efficacy and safety of Android artificial pancreas system use at home among adults with type 1 diabetes mellitus in China: protocol of a 26-week, free-living, randomised, open-label, two-arm, two-phase, crossover trial

“…Several studies from self-reported data have preliminarily observed the efficacy and safety of DIY APS among patients with T1DM. [18][19][20][21][22][23][24][25] However, these studies with small sample sizes and highly selective, observational, single-arm and before-after controlled designs make it difficult to reach conclusions. High-quality evidence is needed to explore DIY APS outcomes.…”