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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Participants will use the normal AIDANET system aggressivity adjustment to achieve target glucose for both the hotel and AIDANET at home periods.
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.
University of California San Francisco
San Francisco, California, United States
Barbara Davis Center, University of Colorado
Aurora, Colorado, United States
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Non-inferiority of mean CGM between FCL and Usual Care
Non-inferiority of the mean CGM between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Time frame: 28 days
GMI derived from mean CGM
Non-inferiority of GMI derived from the mean CGM between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Time frame: 28 days
Time in range 70-180 mg/dL
Non-inferiority of time in range 70-180 mg/dL between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Time frame: 28 days
CGM standard deviation (StDev)
Non-inferiority of CGM standard deviation (StDev) between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Time frame: 28
CGM coefficient of variation (CV)
Non-inferiority of CGM coefficient of variation (CV) between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Time frame: 28 days
CGM %<54 mg/dL
Non-inferiority of CGM %\<54 mg/dL between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Time frame: 28 days
CGM %<70 mg/dL
Non-inferiority of CGM %\<70 mg/dL between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
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Time frame: 28 days
CGM %>180 mg/dL
Non-inferiority of CGM %\>180 mg/dL between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Time frame: 28 days
CGM %>250 mg/dL
Non-inferiority of CGM %\>250 mg/dL between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Time frame: 28 days
Non-inferiority of mean CGM between Normal Glycemia Goal and Tight Glycemia Goal
Mean CGM and other outcomes listed above will be assessed between Normal Glycemia Goal and Tight Glycemia Goal groups
Time frame: 17 days