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)

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Sue Brown
Study ID
NCT07039617
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • AIDANET + FCL — DEVICE
    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 — DEVICE
    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 — DEVICE
    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) — OTHER
    Participants will manage their diabetes as they normally do at home.

Study Details

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 Dates

Start date
Sep 2, 2025
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

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

Arms

  • Experimental: Group A
    Group A: AID first followed by AIDANET-FCL, AIDANET-HCL and then AIDANET-FCL-HCL mix
  • Experimental: Group B
    Group B: AIDANET-FCL first followed by AIDANET-HCL, AIDANET- FCL-HCL mix and AID

Primary Outcome Measure

Time in Range (70-180 mg/dL) [ Time Frame: 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Center for Diabetes TechnologyCharlottesvilleVirginia22903
Sue A Brown, MD
[email protected]
434-982-0602
Marc Breton, PhD (SUB_INVESTIGATOR)
Mark DeBoer, MD, MSc, MCR (SUB_INVESTIGATOR)
Anas El Fathi, PhD (SUB_INVESTIGATOR)
Samina Afreen, MD (SUB_INVESTIGATOR)
Marcela Moscoso-Vasquez, PhD (SUB_INVESTIGATOR)

Find similar trials in Charlottesville, VA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Virginia Center for Diabetes Technology· Charlottesville, VA

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