The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for young children (2 yo to less than 6 yo) with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control.
Participants will be randomized to closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) or to standard of care where the children will continue to use his or her personal insulin pump or multiple daily injections. Both groups will use a continuous glucose monitor (CGM) throughout the study. The study system will also use a study insulin pump and a software algorithm to automatically give insulin and control blood glucose. This system is also sometimes called a "closed-loop" system. This study will take about 6-7 months for the child to complete. Study visits can be completed from home via videoconference (e.g. Zoom) without visiting the clinic or in-person at the clinic. A subset of participants will be asked to join an ancillary study with Meal Bolus and Exercise challenges during the extension phase. Data collected from the start of each of these challenges until the following morning will be excluded from the analysis of the extension phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
The Tandem t:slim X2 with Control-IQ Technology Pro is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is very similar to the commercially available t:sli X2 with Control-IQ but modified to accept the lower weight and Total Daily Insulin of the studied population.
Standard of Care consists in the participant existing insulin therapy (prior to enrollment) in conjunction with a study Dexcom G6 CGM. Existing insulin therapies are defined as multiple daily injections of insulin (MDI) or use of an insulin pump without hybrid closed-loop control capabilities (low-glucose suspend or predictive low-glucose suspend functionality is permitted).
Stanford University
Stanford, California, United States
Barbara Davis Center, University of Colorado
Aurora, Colorado, United States
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Time in Range
Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM
Time frame: 13 weeks
CGM-measured Percent Above 250 mg/dL
Percentage of time with a glucose above 250 mg/dL as measured by CGM
Time frame: 13 weeks
CGM-measured Mean Glucose
Average glucose value measured by CGM
Time frame: 13 weeks
HbA1c at 13 Weeks
HbA1c at 13 weeks
Time frame: 13 weeks
CGM-measured Percent Below 70 mg/dL
Percentage of time with glucose below 70 mg/dL as measured by CGM
Time frame: 13 weeks
CGM-measured Percent Below 54 mg/dL
Percentage of time with glucose below 54 mg/dL as measured by CGM
Time frame: 13 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Tandem t:slim X2 with Control-IQ Technology V1.5 is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is derived from the commercially available t:slim X2 with Control-IQ, with additional features.