Qualitative Study of User Experiences with Loop, an Open-Source Automated Insulin Delivery System.

Background: Loop is an open-source automated insulin delivery (AID) system, used by more than 9,000 people with type 1 diabetes. Understanding the pros and cons of Loop use may help improve disease management and support population level innovation. Methods: Focus groups revealed 72 new and existing users' perspectives on Loop uptake, use, and persistence. A subsample of participants from a mixed-methods, observational cohort study shared first-hand accounts of their experiences using Loop. Participants were predominately white (95%), male (50%), privately insured (94%), and reported annual household income ≥$100K (73%) and education exceeding a bachelor's degree (87%) with a mean HbA1c of 6.6% ± 0.8%. Data were analyzed and synthesized by a multidisciplinary team. Results: Participants detailed their experiences with (1) Loop technical support and troubleshooting, (2) decreased mental/behavioral burden, (3) technical issues with parts of the system, (4) glycemic control, (5) personalizing settings, and (6) providers while using Loop. Decreased burden was the most endorsed benefit defined by less worry, stress, and cognitive effort and less time spent on diabetes management tasks. Participants highlighted the benefits of Loop overnight and their introduction to "Loop communities" during use. The most discussed challenges involved technical issues. A range of provider attitudes and knowledge about Loop complicated users' clinical experiences and disclosure. Conclusions: This sample of new and experienced Loop users reported benefits to quality of life and glycemic control that outweighed challenges of setting up system components, customizing the system to suit one's lifestyle and habits, and adjusting system settings. Challenges related to system setup and calibrating settings are remediable and, if addressed, may better serve Loop users. Users reported feeling empowered by the customizability of and the educational effects facilitated by the open-source AID system. Loop helped users learn more about their chronic illness and physiology in an acceptable format. Clinical Trial Registration number: NCT03838900.

Discontinued Use of the Loop Insulin Dosing System: A Mixed-Methods Investigation.

Background: Loop is an open-source automated insulin dosing system that allows users unrivaled control over system settings that affect future glucose prediction. Thousands use Loop, but little is known about those who discontinue. Methods: In a large observational study, 874 Loop participants completed surveys and provided glycemic data, 46 (5.3%) of those self-identified as discontinuing Loop use during the observation window, 45 completed a discontinued use survey, 22 provided system settings data, and 19 participated in semistructured interviews about their discontinuation. Qualitative data were transcribed, coded, and analyzed. Results: Older age and not trusting Loop were associated with discontinued use, although no other demographic or clinical characteristics were significant correlates. The most endorsed reasons were "I decided to try something else" (27.8%) followed by "It just didn't help as much as I thought it would" (22.2%). Qualitative analyses revealed prominent themes centered upon mental and emotional burden and adjusting settings. Other reasons for discontinued use included fear of disapproval of Loop use from diabetes provider, barriers to acquiring component devices, a desire to try new/different technologies, concerns that Loop could not accommodate specific exercise or low insulin dose regimens, and worry about Loop use during pregnancy. It was noted that burdens might be alleviated by enhanced technical assistance and expert guidance. Conclusions: Although the majority of individuals in the Loop observational study continued use, those who discontinued reported similar challenges. Technical support and education specific to setting calculations could expand Loop benefits, alleviate burden, and support sustained use among new Loop users. Clinical Trial Registration: clinicaltrials.gov (NCT03838900).