RecruitingNot ApplicableNCT07020936

AIDANET Pediatrics

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

Sponsor

Mark D. DeBoer, MD, MSc., MCR

Enrollment

36 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes

Summary

AIDANET algorithm with smart-phone based control system (study smart phone), specifically modified Tandem insulin system (study insulin pump), and Dexcom G6 CGM (study CGM).

Eligibility

Min Age: 6 YearsMax Age: 13 Years

Plain Language Summary

Simplified for easier understanding

This study (AIDANET Pediatrics) is testing an AI-powered automated insulin delivery system in children and preteens with type 1 diabetes, to see if it can better manage blood sugar compared to existing pump systems. **You may be eligible if...** - Your child is between 6 and 13 years old - They have had type 1 diabetes for at least one year - They have been using an insulin pump for at least 3 months - They currently use a Dexcom G6 or G7 continuous glucose monitor (CGM) - A parent or guardian who lives with the child can respond to low blood sugar emergencies **You may NOT be eligible if...** - Your child is currently pregnant or breastfeeding - They have other conditions that significantly affect blood sugar management - They are unwilling to use the insulin types required for the study (lispro or aspart) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENormal Glycemia Goal

Participants will use the normal AIDANET system aggressivity adjustment to achieve target glucose for both the hotel and AIDANET at home periods.

DEVICETight Glycemia Goal

Participants will have the AIDANET system controller target set to have higher aggressivity adjustment to maintain target glucose for both the hotel and AIDANET at home periods.