This feasibility study is a prospective, single arm study evaluating the Tandem Freedom system in adults with type 1 diabetes. Existing Control-IQ technology users will use Control-IQ technology at home for a 1 week run-in, then will use Tandem Freedom in a supervised hotel setting.
After a 1 week Control-IQ run-in at home, 10 adults who are existing Control-IQ users with type 1 diabetes will use the Tandem Freedom System for 1 day with boluses, and 1 day without boluses, in a supervised hotel setting. Participants will perform meal and exercise challenges. The primary outcome is safety events. CGM time in ranges will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Participants will use the Tandem Freedom system for one day with insulin boluses and one day without insulin boluses.
University of Otago
Christchurch, New Zealand
Severe Hypoglycemia Events
Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment)
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Diabetic Ketoacidosis Events
Number of diabetic ketoacidosis events
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Percent Time <54 mg/dL
CGM measured percent time \<54 mg/dL
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Percent Time <70 mg/dL
CGM measured percent time \<70 mg/dL
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Percent Time in Range 70 - 180 mg/dL
CGM measured percent time in range 70 - 180 mg/dL
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Percent Time in Range 70 - 140 mg/dL
CGM measured percent time in range 70 - 140 mg/dL
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Percent Time >180 mg/dL
CGM measured percent time \>180 mg/dL
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
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Percent Time >250 mg/dL
CGM measured percent time \>250mg/dL
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Mean Glucose (mg/dL)
CGM measured mean glucose (mg/dL)
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Glucose Coefficient of Variation (%)
CGM measured Coefficient of Variation (%)
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Glucose Standard Deviation (mg/dL)
CGM measured Standard Deviation (mg/dL)
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus