An observational study in Diabetes Mellitus, Type 1, sponsored by Tandem Diabetes Care, Inc.. Recruiting at 25 sites in France. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Tandem Diabetes Care, Inc. · Observational
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:
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 350 is above the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Tandem Diabetes Care, Inc. is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will use the Control-IQ System as per standard of care.
Device: t:slim X2 insulin pump with Control-IQ technology (Control-IQ System)
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2027, 21 months after the start.
Of 50 industry-sponsored observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 21 months is close to that.
Counting every sponsor, half of 299 studies reached it within 30 months; a quarter within 12 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Tandem Diabetes Care, Inc.