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
47 weeks
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
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.
CONDITIONS
Official 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
- Use of an FDA-approved automated insulin delivery system within the last six months (intermittent use allowed)
- Currently using insulin for at least six months
- Willingness to switch to an FDA-approved personal insulin for the study pump if directed
- Has one or more companions knowledgeable about emergency procedures for severe hypoglycemia who live with or near the participant
- Not known to be pregnant or breastfeeding
- If able to become pregnant, agrees to use contraception and will have a negative pregnancy test; will discontinue if pregnancy occurs or is planned during the study
- Willingness to wear a Dexcom continuous glucose monitor during all four study phases
- Willingness to use the study AIDANET system during relevant periods
- Willingness not to start any new non-insulin glucose-lowering medication during the trial
- Willingness to participate in all study procedures including in-person training
- Access to internet at home and willingness to upload data as needed
- Investigator confidence in the ability to operate study devices and adhere to the protocol
- Proficiency in reading and verbal communication in English
You will not qualify if you...
- Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors) unless on stable dose for at least one month
- Current use of sulfonylurea medications
- Current use of SGLT-2 or SGLT-1/2 inhibitors due to risk of diabetic ketoacidosis
- Hemophilia or any other bleeding disorder
- History of severe hypoglycemic events with seizure or loss of consciousness in the past 12 months
- History of diabetic ketoacidosis in the past 12 months
- Currently on peritoneal or hemodialysis
- Currently being treated for adrenal insufficiency
- Currently being treated for a seizure disorder
- Hypothyroidism or hyperthyroidism that is not adequately treated
- Use of oral or injectable steroids at enrollment
- Known ongoing adhesive intolerance not well managed
- Any condition that could put participant or study at risk as judged by investigator
- Participation in another interventional trial at enrollment
- Participant has a direct supervisor at work or school involved in the trial
AI-Screening
AI-Powered Screening
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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
CONTACT
C
Carlene Alix
CONTACT
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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