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RECRUITING
NCT07507708
NA

Insulin Delivery With Self-Adjusting Closed-Loop and Behavioral Glycemic Control Enhanced by Prediction

Sponsor: Sue Brown

View on ClinicalTrials.gov

Summary

This study is a randomized cross-over trial comparing AIDANET with Anticipation to AIDANET in FCL without Anticipation. Participants will complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then be randomized to one of two groups: Group A: AIDANET in FCL with Anticipation (AIDANET+ACL), and Group B: AIDANET in FCL without Anticipation (AIDANET+FCL). The study duration of each group is 4 weeks each. The order of these two phases will be dependent upon randomization.

Official title: Insulin Delivery With Self-Adjusting Closed-Loop and Behavioral Glycemic Control Enhanced by Prediction (INSIGHT)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-05-14

Completion Date

2026-12-31

Last Updated

2026-06-22

Healthy Volunteers

No

Interventions

DEVICE

Automated Insulin Delivery (AID)

Usual Care

DEVICE

AIDANET + Fully Closed Loop (FCL)

All participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.

DEVICE

AIDANET + Anticipatory Closed Loop (ACL)

All insulin will be delivered automatically. The algorithm will review past behaviors to determine the amount of insulin that will be needed for a meal.

Locations (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States