The goal of this clinical trial is to assess safety of and explore glycemic outcomes with Control-IQ technology 2.0 in adults, children and preschoolers with type 1 diabetes.
This feasibility study is a prospective, randomized, two-period crossover multi-center study of Control-IQ technology 2.0. After a two week run-in period, the automated insulin dosing (AID) system will be evaluated in multiple age groups over 4 weeks of use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor.
Barbara Davis Center (Pediatric Clinic)
Aurora, Colorado, United States
Barbara Davis Center
Aurora, Colorado, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
University of Virginia
Charlottesville, Virginia, United States
Number of Severe Hypoglycemic Events
Number of severe hypoglycemic events (with cognitive impairment such that assistance of another individual is needed for treatment) during study compared with data on severe hypoglycemic events reported by T1D Exchange clinic registry over a 3-month time period
Time frame: 2 weeks
Number of Diabetic Ketoacidosis (DKA) Events
Number of diabetic ketoacidosis during study compared with data on DKA events, compared with data on DKA events reported by T1D Exchange clinic registry over a 3-month time period
Time frame: 2 weeks
Percent of Time <54 mg/dL
CGM percent time \<54 mg/dL during each study period.
Time frame: 2 weeks
Percent of Time <70 mg/dL
CGM percent time \<70 mg/dL during each study period.
Time frame: 2 weeks
Percent Time 70-140 mg/dL
CGM percent time 70-140 mg/dL during each study period.
Time frame: 2 weeks
Percent Time 70-180 mg/dL
CGM percent time 70-180 mg/dL during each study period.
Time frame: 2 weeks
Percent Time > 180 mg/dL
CGM percent time \>180 mg/dL during each study period.
Time frame: 2 weeks
Percent Time > 250 mg/dL
CGM percent time \>250 mg/dL during each study period.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 2 weeks
Mean Glucose
Mean CGM glucose mg/dL during each study period.
Time frame: 2 weeks
Glucose SD
Glucose SD mg/dL during each study period.
Time frame: 2 weeks
Glucose Coefficient of Variation
Glucose Coefficient of Variation (%) during each study period.
Time frame: 2 weeks