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RECRUITING
NCT07039617
NA

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

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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.

DEVICE

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.

OTHER

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