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.
BACKGROUND Despite being an unapproved method of insulin delivery, increasing numbers of people with type 1 diabetes (T1D) worldwide are choosing to use Loop, a Do-It-Yourself Automated Insulin Delivery system. OBJECTIVE 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 using Loop was performed. Assessment of glycemic; HbA1c and time in range (TIR), and safety outcomes; hospital admissions and time below range (TBR), compared six months of Loop with the user’s prior regulatory approved insulin delivery method. QOL outcomes were assessed using INSPIRE, Diabetes Impact and Device Satisfaction (DIDS) measures (with maximum scores of 100, 10 and 10), and semi-structured interviews. RESULTS 24 adults with T1D, 66.7% female, median (IQR) age 33 (28-45), duration of diabetes 22 years (17-32), with duration of Loop 18 months (12-25). With Loop, median (IQR) HbA1c 7.1% (6.5-7.5), 54mmol/mol (48-58) and TIR 76.5% (64.6-81.9); a significant improvement from prior therapy (p=0.001 and p=0.005), with a non-significant reduction in time 3.0-3.9mmol/L (p=0.17) and <3mmol/L (p=0.53). Two episodes of DKA and no severe hypoglycemia occurred in a total of 470 months Loop use. Positive QOL impact was explored in qualitative analysis and additionally demonstrated through median (IQR) INSPIRE 86 (79-95), DI 2.8 (2.1-3.9) and DS 9 (8.2-9.4). CONCLUSIONS This local cohort of people with T1D, demonstrate a beneficial effect of Loop use on both glycemic control and QOL, with no safety concerns highlighted. CLINICALTRIAL N/A
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