RecruitingNot Applicable

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

France350 participantsStarted 2026-03-03

Plain-language 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.

Who can participate

Age range6 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

Rate of diabetic ketoacidosis (DKA).

Timeframe: 12 months

Rate of severe hypoglycemia (SH)

Timeframe: 12 months

Trial details

NCT IDNCT07211126

SponsorTandem Diabetes Care, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-12

Contact for this trial

Arthur Senigout

+33 6 85 98 40 44 record-iq@sanoia.com

View on ClinicalTrials.gov More Diabetes Mellitus, Type 1 trials