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.
This post-market surveillance study is a single-arm, prospective cohort study. It is designed to: 1. Demonstrate, in the post-approval setting, the safety of the Control-IQ System for the management of type 1 diabetes by assessing the rate of severe metabolic complications (severe hypoglycemia and/or diabetic ketoacidosis). 2. Determine glycemic outcomes during real-world use of the Control-IQ System over 12 months post-initiation. 3. Demonstrate patient-reported satisfaction with the device, trust in the Control-IQ System, usability of the system, and improved quality of life. 4. Describe the real-world use of the Control-IQ System.
Study Type
OBSERVATIONAL
Enrollment
350
Participants 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.
Time frame: 12 months
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 frame: 12 months
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 frame: 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 frame: 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 frame: 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.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time less than 54 mg/dL
The change in (%) time spent less than 54 mg/dL, defined as the proportion of sensor glucose concentration less than 54 mg/dL, between baseline and 12 months.
Time frame: 12 months
Treatment Satisfaction
To evaluate treatment satisfaction based on the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) scores at baseline through 12 months.
Time frame: 12 months
System Usability
To evaluate treatment satisfaction based on the System Usability Scale (SUS) scores at baseline through 12 months.
Time frame: 12 months
Quality of Life Change
To evaluate change in quality of life based on the EQ-5D scores at baseline through 12 months.
Time frame: 12 months
Fear of Hypoglycemic Events Change
To evaluate change in fear of hypoglycemic events based on the Hypoglycemia Fear Survey (HFS) from baseline through 12 months.
Time frame: 12 months
Rate of use of the system
To determine the rate of use of the system as established by % time in closed-loop, from baseline through 12 months.
Time frame: 12 months