CLOSE IT Trial Tests Fully Automated Android Artificial Pancreas System

Comparing Automated Insulin Delivery Systems in Type 1 Diabetes Care

While various automated insulin delivery systems are already commercially available following randomised controlled trials, their real-world utility can face friction from user-associated burdens. To address these hurdles, researchers are turning their attention toward fully automated closed loop technology.

The CLOSE IT trial—short for Closed Loop Open SourcE In Type 1 diabetes—is designed as a randomised, open-label, parallel, non-inferiority trial. It directly compares the Android Artificial Pancreas System algorithm used as a fully automated closed loop system to the exact same algorithm operating as a hybrid closed loop system.

Trial Design and Participant Responsibilities Across Treatment Arms

Participants in the trial are randomised in a 1:1 ratio into one of two distinct treatment arms. Those placed in the fully automated closed loop arm are explicitly advised not to deliver boluses for meals. Conversely, participants in the hybrid closed loop arm use the algorithm with announced meals, maintaining manual oversight.

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• The primary outcome measures the percentage of time users spend in the target sensor glucose range of 3.9 to 10.0 mmol/L.
• Secondary outcomes track broader glycaemic metrics, safety profiles, psychosocial factors, platform performance, and user dietary factors.

Ethics approvals for the study protocol were secured through the Alfred Health Ethics Committee under reference 615/22 in Australia, as well as the Health and Disability Ethics Committees under reference 2022 FULL 13832 in New Zealand. Every participant provides written informed consent, and data protection protocols ensure confidentiality throughout the research.

Extension Phase Examining Insulin Variations and Dissemination Plans

Beyond the core 12-week comparison, a subset of 20 participants from the fully automated closed loop arm will transition into a 4-week extension phase. This subsequent phase focuses on comparing glycaemic and dietary outcomes when utilizing NovoRapid, which contains insulin aspart, against Fiasp, which combines insulin aspart and niacinamide.

Trial registration numbers for the research are listed as ACTRN12622001400752 and ACTRN12622001401741. Regarding the future release of findings, study results are planned for dissemination via peer-reviewed publications, academic conferences, and patient advocacy groups.