LOOP OBSERVATIONAL STUDY: EVALUATING DO-IT-YOURSELF (DIY) AUTOMATED INSULIN DELIVERY
- John Lum, United States of America
- John Lum, United States of America
- Victoria Barnes-lomen, United States of America
- Ryan Bailey, United States of America
- Diana Naranjo, United States of America
- Korey Hood, United States of America
- Rayhan Lal, United States of America
- Daniel Desalvo, United States of America
- Jeremy Pettus, United States of America
- Peter Calhoun, United States of America
- Roy W. Beck, United States of America
Abstract
Background and Aims
Loop is a DIY app for automated insulin delivery using an iPhone and commercial continuous glucose monitor (CGM) and insulin pump. This study evaluates glycemic control, adverse event rates, and patient-reported outcomes (PROs) among individuals with type 1 diabetes (T1D) using Loop.
Methods
Two groups were enrolled in this ongoing observational study: participants using Loop at enrollment (Existing Users) and those planning to start Loop (New Users). Device data are collected via the Tidepool Mobile App, including available CGM data at enrollment and throughout follow-up. PRO data are collected at baseline, 3, 6, and 12 months. Adverse events (severe hypoglycemia, diabetic ketoacidosis, and hospitalizations) are monitored weekly.
Results
Among 875 participants, mean age was 27±17 years (range 1-77, 42% <18 years old), 55% were female, 93% were Caucasian, 85% of participants (households, if <18 years old) had a bachelor’s degree or higher, and median diabetes duration was 12 years (IQR: 5-24). Enrollment included 266 Existing Users (44% using Loop for >12 months) and 609 New Users. Existing Users mostly had Medtronic pumps (85%, versus 15% OmniPod), while New Users mostly used OmniPod (91%). Baseline glycemic metrics at enrollment are reported in the table; for Existing Users, CGM time-in-range 70-180 mg/dL was 81%, with median 0.44% time <54 mg/dL.
Conclusions
Participants using Loop prior to enrollment had high time-in-range at baseline with little hypoglycemia. Three-month follow-up will be completed in December 2019, and efficacy and safety data will be presented as well as PROs.