Actively Recruiting
AIDANET Pediatrics
Led by Mark D. DeBoer, MD, MSc., MCR · Updated on 2025-12-10
36
Participants Needed
3
Research Sites
36 weeks
Total Duration
On this page
Sponsors
M
Mark D. DeBoer, MD, MSc., MCR
Lead Sponsor
T
Tandem Diabetes Care, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
AIDANET Pediatrics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 to 13 years old at time of consent
- Clinical diagnosis of type 1 diabetes for at least one year
- Using an insulin pump for at least three months (any type)
- Using insulin for at least six months
- Willing to use lispro or aspart insulin in the pump during the study
- Currently using a Dexcom G6 or G7 continuous glucose monitor
- Has a parent or guardian knowledgeable about severe hypoglycemia emergency procedures who lives with the participant
- Not currently pregnant or breastfeeding
- If able to become pregnant, agrees to use contraception and has a negative pregnancy test; will discontinue if pregnancy occurs or is planned during the study
- Willing to use the study's full closed-loop system (CGM, pump, and phone) during the study
- Willing not to start new non-insulin glucose-lowering medications during the trial
- Willing to participate in all study procedures including supervised hotel sessions and to consume about three unannounced meals per day during these sessions
- Has internet access at home and agrees to upload data as needed
- Investigator believes participant can operate study devices and follow the protocol
- Proficient in reading and writing English
You will not qualify if you...
- Plans to start new non-insulin glucose-lowering medications during the study (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors, sulfonylureas)
- Currently using SGLT-2 or SGLT-1/2 inhibitors
- Has hemophilia or another bleeding disorder
- History of severe low blood sugar events with seizure or unconsciousness in the past 6 months
- History of diabetic ketoacidosis in the past 6 months
- Chronic kidney disease (Stage 4 or unstable Stage 3b) or on dialysis
- History of adrenal insufficiency
- Currently treated for a seizure disorder
- Under-treated hypothyroidism or hyperthyroidism
- Coronary artery disease or heart condition preventing moderate exercise
- Use of oral or injectable steroids within 4 weeks before enrollment
- Planned surgery during the study period
- Known ongoing adhesive intolerance not well managed
- Any condition that may put participant or study at risk as judged by the investigator
- Participation in another interventional trial at enrollment
- Participant has a direct supervisor involved in the study conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
2
Barbara Davis Center, University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
L
Lianna Smith
CONTACT
S
Sara Prince, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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