This post-market surveillance study is primarily designed to demonstrate the ongoing safety of the Control-IQ system, the ongoing performance of glycemic control and quality of life with Control-IQ system use, and the rate of use of the Control-IQ system. The system will be assessed in all approved populations during the first 12 months of use.
Clinician-confirmed type 1 diabetes and for whom the site has initiated the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with a Dexcom G6 or G7 CGM sensor.
Age ≥ 6 years at enrollment.
Using an insulin approved for use in the pump.
Ability for patient or parent/guardian to respond to alerts and alarms, and to provide basic diabetes self-management.
A medical or other condition, or medications being taken that, in the investigator's judgement would be a safety concern for participation in the study.
Patients considered vulnerable under French law.
All individuals with Type 1 Diabetes age 6+, who start therapy with the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with a Dexcom G6 or Dexcom G7 and meet eligibility criteria.
Cohort
Prospective
t:slim X2 insulin pump with Control-IQ technology (Control-IQ System)
DeviceParticipants enrolled in the study will start use of the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with Dexcom G6 or Dexcom G7, and be followed for 12 months.
Rate of diabetic ketoacidosis (DKA).
The incidence rate of diabetic ketoacidosis (DKA) will be calculated by dividing the total number of events observed in the entire cohort over the 12-month follow-up period. Results will be expressed as the number of events per 100 patient-years.
Rate of severe hypoglycemia (SH)
The incidence rate of severe hypoglycemia (SH) will be calculated by dividing the total number of events observed in the entire cohort over the 12-month follow-up period. Results will be expressed as the number of events per 100 patient-years.
Time in Range 70-180 mg/dL (TIR)
The change in (%) time spent within range, defined as the proportion of sensor glucose concentration within the target range of 70-180 mg/dL, between baseline and 12 months.
Time above 180 mg/dL
The change in (%) time spent above 180 mg/dL, defined as the proportion of sensor glucose concentration above 180 mg/dL, between baseline and 12 months.
Time above 250 mg/dL
The change in (%) time spent above 250 mg/dL, defined as the proportion of sensor glucose concentration above 250 mg/dL, between baseline and 12 months.
Time less than 70 mg/dL
The change in (%) time spent less than 70 mg/dL, defined as the proportion of sensor glucose concentration less than 70 mg/dL, between baseline and 12 months.
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