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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Sue Brown
Study ID
NCT07507708
Status
Recruiting
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Conditions

  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Automated Insulin Delivery (AID) — DEVICE
    Usual Care
  • AIDANET + Fully Closed Loop (FCL) — DEVICE
    All participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.
  • AIDANET + Anticipatory Closed Loop (ACL) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 14, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A: AID first followed by AIDANET+ACL then AIDANET+FCL
    Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Anticipatory Closed Loop (ACL) and 4 weeks of AIDANET + Fully Closed-Loop (FCL)
  • Active Comparator: Group B: AID first followed by AIDANET+FCL then AIDANET+ACL
    Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Fully Closed Loop (FCL) and 4 weeks of AIDANET+ Anticipatory Closed Loop (ACL).

Primary Outcome Measure

Time in range 70-140 mg/dL as computed by the study CGM [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Center for Diabetes TechnologyCharlottesvilleVirginia22903
Sue Brown, MD
[email protected]
4349820602
Marcela Moscoso-Vasquez, PhD (SUB_INVESTIGATOR)
Samina Afreen, MD (SUB_INVESTIGATOR)
Mark DeBoer, MD (SUB_INVESTIGATOR)
Driscoll Kimberly, PhD (SUB_INVESTIGATOR)

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By research site
University of Virginia Center for Diabetes Technology· Charlottesville, VA

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