Safety and Feasibility Testing of AIDANET in Children Age 6-13 Years
Mark D. DeBoer, MD, MSc., MCR
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).
Description
This study aims to demonstrate the safety and feasibility of the Automated insulin delivery as Adaptive NETwork (AIDANET) system among children age 6-13 years. This includes use of new features allowing requested correction boluses and setting a tighter glycemia goal. The proposed work is a safety and feasibility study of the FCL system and is not intended to be powered to fully demonstrate efficacy of the system. The sample size of up to 24 completed participants was selected based on previous experience of the feasible number of individuals to supervise at one time under similar study condi…
Eligibility
- Age range
- 6–13 years
- Sex
- All
- Healthy volunteers
- No
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…
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.
Locations (3)
- University of California San FranciscoSan Francisco, California
- Barbara Davis Center, University of ColoradoAurora, Colorado
- University of Virginia Center for Diabetes TechnologyCharlottesville, Virginia