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. 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 conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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
RECRUITINGBarbara Davis Center, University of Colorado
Aurora, Colorado, United States
RECRUITINGUniversity of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
RECRUITINGNon-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