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 one week run-in, then will use Tandem Freedom in a supervised hotel setting.
After a one 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 4 nights: 1 day with boluses, and 3 days without boluses, in a supervised hotel setting. Participants will perform 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
t:slim X2 insulin pump with Tandem Freedom System consists of the Tandem t:slim X2 insulin pump and the Freedom algorithm embedded in the pump. Participants will also use the Dexcom G6 continuous glucose monitoring system.
University of Otago
Christchurch, New Zealand
Number of Participants With One or More Severe Hypoglycemia Events
Number of Participants with One or More Severe Hypoglycemia Events (with cognitive impairment such that assistance of another individual is needed for treatment)
Time frame: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)
Number of Participants With One or More Diabetic Ketoacidosis Events
Number of Participants with One or More Diabetic Ketoacidosis events
Time frame: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)
Percent Time <54 mg/dL
CGM measured percent time \<54 mg/dL
Time frame: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)
Percent Time <70 mg/dL
CGM measured percent time \<70 mg/dL
Time frame: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)
Percent Time in Range 70 - 180 mg/dL
CGM measured percent time in range 70 - 180 mg/dL
Time frame: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)
Percent Time in Range > 180 mg/dL
CGM measured percent time in range \> 180 mg/dL
Time frame: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)
Percent Time in Range > 250 mg/dL
CGM measured percent time in range \> 250 mg/dL
Time frame: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)
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Percent Time in Range 70 - 140 mg/dL
CGM measured percent time in range 70 - 140 mg/dL
Time frame: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)
Median of Mean Glucose (mg/dL)
Median of each participant's mean glucose values (mg/dL)
Time frame: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)
Glucose Coefficient of Variation (%)
CGM measured Coefficient of Variation (%)
Time frame: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)
Glucose Standard Deviation (mg/dL)
CGM measured Standard Deviation (mg/dL)
Time frame: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)