Safety and Feasibility Testing of a Smaller Network Version of AIDANET

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Marc Breton
Study ID
NCT06633965
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • AIDANET — DEVICE
    AIDANET is a fully automated, utilizing a Bolus Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin prior to extreme blood sugar excursions.
  • AIDANET — DEVICE
    AIDANET is a fully automated, utilizing a Bolus Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin prior to extreme blood sugar excursions.

Study Details

A randomized 1:1 crossover trial that intends to demonstrate feasibility and safety of the Automated Insulin Delivery as Adaptive NETwork (AIDANET) system run in a new smaller network version, used in full closed loop (FCL) by adults who have been diagnosed with type 1 diabetes (T1D).

Key Dates

Start date
Nov 20, 2024
Status verified
Jul 2025
Primary completion
Dec 16, 2024
Completion
Dec 18, 2024

Study Design

Enrollment
8 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Usual Care→AIDANET
    Participants will complete 7 days/6 nights at home usual care period using their personal equipment. Participants will then use the AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights.
  • Active Comparator: AIDANET→Usual Care
    Participants will use AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights and then will complete 7 days/6 nights at home usual care period using their personal equipment.

Primary Outcome Measure

Change in the Mean Continuous Glucose Monitor (CGM) Between the Week of the Usual Care Observational Period and the Week of AIDANET At-Home. [ Time Frame: 2 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22904-

Find similar trials in Charlottesville, VA

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

Related Studies