Actively Recruiting
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)
Led by Sue Brown · Updated on 2026-04-02
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sue Brown
Lead Sponsor
T
Tandem Diabetes Care, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the AIDANET automated insulin delivery algorithm in adults with Type 1 Diabetes. This randomized cross-over trial compares AIDANET used in three modes: fully closed loop (FCL), hybrid closed loop (HCL), and a mixed mode allowing users to switch between FCL and HCL. The study aims to assess glycemic control by comparing AIDANET with usual care automated insulin delivery systems currently used by participants. Participants will use the AIDANET system in three separate 4-week phases, first using either the HCL or FCL mode in random order. Then, they will use the mixed FCL-HCL mode for 4 weeks, choosing their preferred mode daily. Additionally, participants will spend 4 weeks using their usual care automated insulin delivery system either before or after the AIDANET phases, depending on their assigned group. The system uses continuous glucose monitoring and an insulin pump managed via a smartphone app. During the study, participants will wear a Dexcom continuous glucose monitor and use the study devices at home. Researchers will monitor blood sugar control, focusing on the time spent in the target glucose range (70-180 mg/dL) over 16 weeks. Participants will be trained on study devices, upload data regularly, and follow study procedures. The total participation involves multiple phases over several months with ongoing monitoring and data collection.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Clinical diagnosis of Type 1 Diabetes for at least one year
- Used an FDA-approved automated insulin delivery system within the last six months (intermittent use allowed)
- Using insulin therapy for at least six months
- Willing to switch to an FDA-approved personal insulin for the study pump as directed
- Has one or more knowledgeable companions about emergency procedures near participant
- Not currently pregnant or breastfeeding
- If capable of becoming pregnant, agrees to use contraception and has a negative pregnancy test
- Willing to wear a Dexcom continuous glucose monitor during study phases
- Willing to use the study AIDANET system during relevant periods
- Willing not to start new non-insulin glucose-lowering agents during the trial
- Willing to participate in all study procedures including in-person training
- Access to internet at home and willingness to upload data as needed
- Investigator confident participant can operate study devices and follow protocol
- Proficient in reading and speaking English
You will not qualify if you...
- Plans to start a new non-insulin glucose-lowering agent
- Current use of sulfonylurea medications
- Current use of SGLT-2 or SGLT-1/2 inhibitors
- Hemophilia or other bleeding disorders
- Severe hypoglycemic events with seizure or loss of consciousness in last 12 months
- Diabetic ketoacidosis event in last 12 months
- Currently on peritoneal or hemodialysis
- Currently treated for adrenal insufficiency
- Currently treated for seizure disorder
- Untreated or inadequately treated thyroid disorders
- Use of oral or injectable steroids at enrollment
- Known ongoing adhesive intolerance not well managed
- Any condition posing risk to participant or study as judged by investigator
- Participation in another interventional trial at enrollment
- Participant has a direct supervisor involved in trial conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants will manage their diabetes as they normally do at home during a 4-week period.
1 to 2 visits depending on randomization group
Duration - 4 weeks
Participants will use the AIDANET system in fully closed loop mode, avoiding meal announcements during a 4-week period.
1 visit per phase (in-person or remote)
Duration - 4 weeks
Participants will use the AIDANET system in hybrid closed loop mode, announcing meal boluses using carbohydrate counting or easy bolus during a 4-week period.
1 visit per phase (in-person or remote)
Duration - 4 weeks
Participants will use the AIDANET system in mixed mode, choosing between fully closed loop and hybrid closed loop daily during a 4-week period.
1 visit per phase (in-person or remote)
Trial Site Locations
Total: 1 location
1
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
L
Lianna Smith
C
Carlene Alix
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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