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NCT Number: NCT07211126

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Agen-Nérac, Agen, France

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About this study

This post-market surveillance study is a single-arm, prospective cohort study. It is designed to:

  • 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).
  • Determine glycemic outcomes during real-world use of the Control-IQ System over 12 months post-initiation.
  • Demonstrate patient-reported satisfaction with the device, trust in the Control-IQ System, usability of the system, and improved quality of life.
  • Describe the real-world use of the Control-IQ System.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 :
  • use Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment.
  • 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.
  • 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.

Treatment and study plan

t:slim X2 insulin pump with Control-IQ technology (Control-IQ System)

Device

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.

Primary outcomes

  1. Rate of diabetic ketoacidosis (DKA).

    Time frame: 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.

  2. Rate of severe hypoglycemia (SH)

    Time frame: 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 outcomes

  1. Time in Range 70-180 mg/dL (TIR)

    Time frame: 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.

  2. Time above 180 mg/dL

    Time frame: 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.

  3. Time above 250 mg/dL

    Time frame: 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.

  4. Time less than 70 mg/dL

    Time frame: 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.

  5. Time less than 54 mg/dL

    Time frame: 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.

  6. Treatment Satisfaction

    Time frame: 12 months

    To evaluate treatment satisfaction based on the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) scores at baseline through 12 months.

  7. System Usability

    Time frame: 12 months

    To evaluate treatment satisfaction based on the System Usability Scale (SUS) scores at baseline through 12 months.

  8. Quality of Life Change

    Time frame: 12 months

    To evaluate change in quality of life based on the EQ-5D scores at baseline through 12 months.

  9. Fear of Hypoglycemic Events Change

    Time frame: 12 months

    To evaluate change in fear of hypoglycemic events based on the Hypoglycemia Fear Survey (HFS) from baseline through 12 months.

  10. Rate of use of the system

    Time frame: 12 months

    To determine the rate of use of the system as established by % time in closed-loop, from baseline through 12 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Arthur Senigout

CONTACT

[email protected]

+33 6 85 98 40 44

Sponsors and collaborators

Lead sponsor

Tandem Diabetes Care, Inc.

Industry

Registry information

Acronym: RECORD-IQ

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 7, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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