AIDANET automated insulin delivery for children with type 1 diabetes

Safety and Feasibility Testing of AIDANET in Children Age 6-13 Years

This will test whether the AIDANET automated insulin delivery system — using a smartphone app, a modified Tandem insulin pump, and a Dexcom G6 continuous glucose monitor — can safely help children ages 6 to 13 with type 1 diabetes manage their blood sugar.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 6 Years to 13 Years
• Sex: All
• Sponsor: University of Virginia (other)
• Locations: 3 sites (San Francisco, California and 2 other locations)
• Trial ID: NCT07020936 on ClinicalTrials.gov

What this trial studies

This is a safety and feasibility study of the Fully Closed Loop AIDANET system in children aged 6–13 with type 1 diabetes. Up to 24 participants who already use an insulin pump and a Dexcom CGM will use the AIDANET algorithm via a study smartphone, a specifically modified Tandem pump, and the Dexcom G6. The system includes new features that allow requested correction boluses and a tighter glycemia target, and participants will be assigned to normal or tight glycemia goal settings. The study is not powered for definitive efficacy but is designed to document safety, usability, and feasibility in the pediatric population.

Who should consider this trial

Good fit: Children 6–13 years old with at least one year of type 1 diabetes who currently use an insulin pump and a Dexcom G6 or G7 CGM and are willing to use lispro/aspart in the pump are ideal candidates.

Not a fit: Children outside the 6–13 age range, those not using an insulin pump or Dexcom G6/G7 CGM, those unable to use lispro/aspart, or those who are pregnant are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the system could help children keep blood glucose closer to target with fewer manual insulin adjustments and potentially less hypoglycemia.

How similar studies have performed: Other automated and hybrid closed-loop systems have shown improved glycemic control and safety in children, but the specific AIDANET setup with requested correction boluses and tighter targets is novel and is being tested for feasibility.

Eligibility criteria

Inclusion Criteria:

1. Age ≥6.0 and ≤13 years old at time of consent
2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
3. Currently using insulin pump for at least three months; Any pump, either open loop or hybrid closed loop may be used.
4. Currently using insulin for at least six months.
5. Willingness to use lispro/aspart in the insulin pump during the study.
6. Currently using a Dexcom G6 or G7 CGM.
7. Has one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that live with participant.
8. Participant not currently known to be pregnant or breastfeeding.
9. 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 females 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.
10. Willingness to use the study FCL system (CGM, pump, and phone) during the relevant study period.
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 the house/hotel session and to consume approximately 3 unannounced meals per day during the relevant portion of the supervised hotel session.
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 writing English.

Exclusion Criteria:

1. Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors, sulfonylureas). Participants may be on a stable dose of such an agent for at least the past month.
2. Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic Diabetic ketoacidosis (DKA).
3. Hemophilia or any other bleeding disorder.
4. History of severe hypoglycemic events with seizure or loss of consciousness in the last 6 months.
5. History of diabetic ketoacidosis (DKA) event in the last 6 months.
6. History of chronic renal disease (Stage 4 or unstable Stage 3b per investigator judgment) or currently on peritoneal or hemodialysis.
7. History of adrenal insufficiency.
8. Currently being treated for a seizure disorder.
9. Hypothyroidism or hyperthyroidism that is not adequately treated.
10. Coronary artery disease or other heart condition that would prevent participation in moderate intensity exercise.
11. Use of oral or injectable steroids at the time of enrollment or within the last 4 weeks.
12. Planned surgery during the study period.
13. Known ongoing adhesive intolerance that is not well managed.
14. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
15. Participation in another interventional trial at the time of enrollment.
16. Participant with a direct supervisor involved in the conduct of the trial.

Where this trial is running

San Francisco, California and 2 other locations

• University of California San Francisco — San Francisco, California, United States (RECRUITING)
• Barbara Davis Center, University of Colorado — Aurora, Colorado, United States (RECRUITING)
• University of Virginia Center for Diabetes Technology — Charlottesville, Virginia, United States (RECRUITING)

Study contacts

• Study coordinator: Lianna Smith

Conditions: Type 1 Diabetes, Adaptive NETwork system, Fully Closed Loop, Specifically modified Mobi system