AIDANET automated insulin delivery in fully closed-loop, hybrid, and mixed modes for adults at home

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)

This trial will test whether the AIDANET automated insulin delivery system helps adults with type 1 diabetes keep blood sugar in range when used in fully closed-loop, hybrid closed-loop, or mixed modes compared with their usual AID system.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Virginia (Academic / other)
• Locations: 1 site (Charlottesville, Virginia)
• Trial ID: NCT07039617 on ClinicalTrials.gov

What this trial studies

This randomized crossover trial compares three ways of running the AIDANET automated insulin delivery algorithm—fully closed-loop (no meal information), hybrid closed-loop (carbohydrate announcement or easy bolus), and a free-choice mixed mode—against participants' usual AID system. Participants use each AIDANET modality across two 4-week phases in randomized order, then a third 4-week phase where they may switch modes freely, plus a separate 4-week usual-care AID phase either before or after the AIDANET periods. The system operates on a modified commercial Mobi pump and uses study-provided and/or personal continuous glucose monitoring devices. Adults with type 1 diabetes who have used an FDA-approved AID system recently will be enrolled and monitored at the University of Virginia Center for Diabetes Technology.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) with type 1 diabetes for at least one year who have used an FDA-approved AID system within the past six months, are on insulin therapy, agree to use study-specified insulin, and have a nearby supportive companion.

Not a fit: People who are pregnant or breastfeeding, under 18, unable or unwilling to use an AID system or to switch insulins, or who lack a nearby supportive companion are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, AIDANET could increase time spent in target glucose range and reduce hypoglycemia while offering users more flexible, lower-burden insulin delivery options.

How similar studies have performed: Commercial and research closed-loop AID systems have previously improved time-in-range and reduced hypoglycemia, although fully closed-loop operation without meal announcements is less commonly proven in large at-home trials.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18.0 years old at time of consent
2. Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes for at least one year.
3. Having used an Food and Drug Administration (FDA) approved AID system within the last six months (can be intermittent use).
4. Currently using insulin for at least six months.
5. Willingness to switch to use an FDA-approved personal insulin for the study pump (e.g., lispro or aspart, or biosimilar FDA-approved products) as directed by the study team.
6. Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff who either lives with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency.
7. Participant not currently known to be pregnant or breastfeeding.
8. If participant capable of becoming pregnant, must agree to use a form of contraception to prevent pregnancy while a participant in the study (e.g. hormonal contraception, abstinence from heterosexual intercourse). A negative serum or urine pregnancy test will be required for all participants of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
9. Willingness to wear a Dexcom CGM during each of the four study phases.
10. Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods.
11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
12. Willingness to participate in all study procedures including in person training.
13. Access to internet at home and willingness to upload data during the study as needed.
14. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
15. Participant is proficient in reading and verbal communication in English.

Exclusion Criteria:

1. Plans to start a new non-insulin glucose-lowering agent (e.g. glucagon-like peptide-1 (GLP-1) receptor agonists, Symlin, (DPP-4 inhibitors, also known as dipeptidyl peptidase 4). Participants may be on a stable dose of such an agent for at least the past month.
2. Current use of sulfonylurea medications.
3. Current use of an Sodium-Glucose Cotransporter 2 (also known as a SGLT-2 or SGLT-1/2 inhibitor) due to risk of euglycemic diabetic ketoacidosis (DKA).
4. Hemophilia or any other bleeding disorder.
5. History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.
6. History of DKA event in the last 12 months.
7. Currently on peritoneal or hemodialysis.
8. Currently being treated for adrenal insufficiency.
9. Currently being treated for a seizure disorder.
10. Hypothyroidism or hyperthyroidism is not adequately treated.
11. Use of oral or injectable steroids at the time of enrollment.
12. Known ongoing adhesive intolerance that is not well managed.
13. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
14. Participation in another interventional trial at the time of enrollment.
15. Participant with a direct supervisor at work/school who is involved in the conduct of the trial.

Where this trial is running

Charlottesville, Virginia

• University of Virginia Center for Diabetes Technology — Charlottesville, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Sue Brown, MD — University of Virginia Center for Diabetes Technology
• Study coordinator: Lianna Smith

Conditions Type 1 Diabetes; Automated Insulin Delivery; Fully Closed Loop; Hybrid Closed Loop; Specifically modified Mobi System; Automated Insulin Delivery as Adaptive NETwork