A prospective, multicenter study of 6 weeks of home use of Control-IQ technology in individuals with type 2 diabetes age 18 and older.
The objective of this prospective, multicenter study is to assess safety and explore glycemic outcomes associated with use of Control-IQ technology in adults with type 2 diabetes who require insulin. After an initial run-in period, all participants will use the study system (pump and CGM) for 6 weeks. Participants will perform exercise challenges once each week during the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
All subjects wearing the t-slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor. Outcomes will be analyzed overall and subgroup analysis will be performed by Group, and by baseline A1c level.
Mayo Clinic
Rochester, Minnesota, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
Texas Diabetes and Endocrinology
Austin, Texas, United States
CGM Time Below 54 mg/dL
CGM-measured percentage below 54 mg/dl, compared to baseline
Time frame: 14 weeks
CGM Time Above 180 mg/dL
CGM-measured percentage above 180 mg/dl, compared to baseline
Time frame: 14 weeks
CGM Time In Range 70-180 mg/dL
CGM-measured percentage in range 70-180 mg/dl, compared to baseline
Time frame: 14 weeks
CGM Time Below 70 mg/dL
CGM-measured percentage below 70 mg/dl, compared to baseline
Time frame: 14 weeks
CGM Time Above 250 mg/dL
CGM-measured percentage above 250 mg/dl, compared to baseline
Time frame: 14 weeks
CGM Time In Range 70-140 mg/dL
CGM-measured percentage in range 70-140 mg/dl, compared to baseline
Time frame: 14 weeks
CGM Mean Glucose mg/dL
CGM measured mean glucose mg/dL, compared to baseline
Time frame: 14 weeks
Coefficient of Variation (CV)
CGM measured glucose variability measured with the coefficient of variation (CV), compared to baseline
Time frame: 14 weeks
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