The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT07211126
• Lead Sponsor: Tandem Diabetes Care, Inc.

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-29
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Study Start: 2025-12-01
• Primary Completion: 2027-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• 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.

• Reside full-time in mainland France.

• Have an email address and mobile phone number

• Participant or participant's parent/guardian has read and understood the information notice and has agreed to participate in the study. This includes agreeing to :

  1. use Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment.
  2. the reuse of their clinical data including HbA1c results, obtained at most 4 months prior to enrollment, and as available according to the standard of care during the next 12 months.
  3. complete questionnaires per the study protocol.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of diabetic ketoacidosis (DKA).	12 months	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)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Time in Range 70-180 mg/dL (TIR)	12 months	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	12 months	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	12 months	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	12 months	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 less than 54 mg/dL	12 months	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.
Treatment Satisfaction	12 months	To evaluate treatment satisfaction based on the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) scores at baseline through 12 months.
System Usability	12 months	To evaluate treatment satisfaction based on the System Usability Scale (SUS) scores at baseline through 12 months.
Quality of Life Change	12 months	To evaluate change in quality of life based on the EQ-5D scores at baseline through 12 months.
Fear of Hypoglycemic Events Change	12 months	To evaluate change in fear of hypoglycemic events based on the Hypoglycemia Fear Survey (HFS) from baseline through 12 months.
Rate of use of the system	12 months	To determine the rate of use of the system as established by % time in closed-loop, from baseline through 12 months.