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A Randomized Parallel Clinical Trial of AIDANET, an Automated Insulin Delivery Algorithm, in Fully Closed-Loop Vs Hybrid Closed-Loop Mode In Adults With Type 1 Diabetes (AIDANET At Home)
Sponsor: Sue Brown
Summary
A randomized cross-over trial assessing glycemic control on Automated insulin delivery as Adaptive Network (AIDANET) algorithm when used in three modes: AIDANET-Fully Closed Loop (FCL), AIDANET-Hybrid Closed Loop (HCL) and AIDANET allowing a mix between FCL and HCL. There will be an Automated Insulin Delivery (AID) phase with participants using their home devices and/or study continuous glucose monitor (CGM) and study-provided commercial Mobi system without AIDANET.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-09-02
Completion Date
2026-07-31
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
AIDANET + FCL
All participants will use AIDANET in fully closed loop (FCL) mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.
AIDANET + HCL
All participants will use AIDANET in hybrid closed loop (HCL) mode with instructions to announce all meal boluses using carbohydrate counting or easy bolus during the four weeks. All components of AIDANET will remain active during this phase but BPS in particular is expected to be triggered less often due to meal announcements.
AIDANET in FCL-HCL-mixed mode
All participants will use AIDANET with instructions to choose whether to use fully closed loop (FCL) or hybrid closed loop (HCL) mode with meal announcements (carb counting or easy bolus) per their discretion each day.
Automated Insulin Delivery (AID) (usual care)
Participants will manage their diabetes as they normally do at home.
Locations (1)
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States