A real‐world study of user characteristics, safety and efficacy of open‐source closed‐loop systems and Medtronic 670G

Abstract

We report a real-world evaluation of the first commercially approved automated insulin delivery (AID) system, MiniMed 670G (670G), and open source-automated insulin delivery (OS-AID) systems. This was undertaken as a retrospective observational study in adults with type 1 diabetes using AID systems for 6 months or longer in a publicly funded health service using clinically validated data. Sixty-eight adults (38 670G, 30 OS-AID systems) were included. OS-AID system users were younger, had a shorter diabetes duration and a higher education status. OS-AID systems displayed a significantly better change in HbA1c (median À0.9% [À0.4%, À1.1%] vs. À0.1% [IQR À0.7%, 0.2%], P = .004) and time in range 3.9-10 mmol/L (mean 78.5%, SD ± 12.0% vs. 68.2% ± 14.7%, P = .024) compared with 670G. Both systems showed minimal hypoglycaemia, with OS-AID systems revealing significantly improved secondary outcomes of mean glucose and percentage of time more than 10 mmol/L, with a higher percentage of time of less than 3 mmol/L. OS-AID system users displayed improved glycaemic outcomes with no clinical safety concerns compared with 670G, although higher weight-adjusted insulin dose and weight gain were noted. The study highlights key differences in OS-AID system user characteristics that are important for interpreting real-world findings from recent OS-AID system studies.

Association of British Clinical Diabetologists, Diabetes Technology Network UK and Association of Children’s Diabetes Clinicians Survey of UK Healthcare Professional Attitudes Towards Open-Source Automated Insulin Delivery Systems

“…Recent reviews of the evidence highlight high levels of user satisfaction and quality of life outcome measures are positive, with excellent self-reported outcomes [8,9]. Validated safety and efficacy outcomes have also been reported with encouraging results from a study of Loop in the USA and a recent real-world comparison between Med-Tronic MiniMed 670G and OS-AID systems in UK [7,8,10,11]. Despite many of the individual component parts being approved, tested and available on the NHS, given the strict requirements for MHRA licensing and CE marking these systems, OS-AID systems remain unapproved at present.…”

“…At the time of this survey the closest commercially available alternative was the Medtronic MiniMed 670G with hybrid closed-loop technology, which has less functionality than OS-AID [ 10 ]. Additionally, professional guidance was not available for use of open-source AID systems and it was unclear where doctors stood ethically in openly supporting these systems.…”

Real‐world evidence on clinical outcomes of people with type 1 diabetes using open‐source and commercial automated insulin dosing systems: A systematic review

“…Three studies investigated multiple AID systems simultaneously, of which two included various types of open‐source AID 9,11 and one study compared the Medtronic 670G with open‐source AID 29 …”

“…Furthermore, the impact of socio‐economic status, ethnicity as well as on individuals with further physical and mental health implications should be considered. A recent report highlights the importance of such studies 29 . It further contrasts the outcomes and participant characteristics, which has important implications for the application of technologies in T1D.…”

Open-source Web Portal for Managing Self-reported Data and Real-world Data Donation in Diabetes Research: Platform Feasibility Study

“…To date, there are no reported issues of this occurring within research leveraging Open Humans. In general, it has been shown elsewhere [ 33 - 35 ] that real-world data are an important and robust source of information in addition to those from clinical trials. Furthermore, we screened both survey and device data for false entries and removed obvious outliers and erroneous entries where necessary.…”