RecruitingNot ApplicableNCT07039617

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

Enrollment

40 participants

Start Date

Sep 2, 2025

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new automated insulin delivery (AID) system for people with Type 1 diabetes, focusing on how well it works and how easy it is to use at home compared to standard care. **You may be eligible if...** - You are 18 years old or older - You have had Type 1 diabetes for at least one year - You have used an FDA-approved automated insulin delivery system at some point in the past 6 months - You are currently using an eligible continuous glucose monitor **You may NOT be eligible if...** - You have Type 2 diabetes or another form of diabetes - You have not used any automated insulin delivery device in the past 6 months - You have serious complications that would make study participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAIDANET + 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.

DEVICEAIDANET + 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.

DEVICEAIDANET 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.

OTHERAutomated 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

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NCT07039617

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