Diabetes Mellitus, Type 1RECORD-IQNCT07211126
The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France
An observational study of Diabetes Mellitus, Type 1, run by Tandem Diabetes Care, Inc. at 25 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 25 sitesFrance
- Study dates
- 3 Mar 2026to Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
25 sites in 1 country
France25 sites, 25 recruiting
- Recruiting
CH Agen-Nérac
Agen, 47923
Alexandra Byczko, +33 (0) 5 53 69 73 18, byczkoa@ch-agen-nerac.fr
- Recruiting
CHU d'Angers
Angers, 49100
Lucie Dufour, 02 41 35 34 54, Lucie.Dufour@chu-angers.fr
- Recruiting
CHU Lyon HFME
Bron, 69677
Karima Rendja, +33 04 27 85 77 27, karima.rendja@chu-lyon.fr
- Recruiting
CHU Dijon
Dijon
Eva Michaud, +33 03 80 29 30 31, eva.michaud@chu-dijon.fr
- Recruiting
Centre du Diabète - Diab-e-Care Hospices Civils de Lyon (HCL)
Lyon, 69003
Sofia Sebaoui, +33 (0) 4 78 86 38 47, sofia.sebaoui@chu-lyon.fr
- Recruiting
Institut de Diabétologie et de Nutrition du Centre (IDNC)
Mainvilliers
Said Bekka, +33 02 36 25 34 13, idehdj4.idnc@lna-sante.com
- Recruiting
Hôpital Européen (APHM)
Marseille, 13003
Audrey Olivetti, +33 04 13 42 74 98, a.olivetti@hopital-europeen.fr
- Recruiting
GHEF Meaux
Meaux, 77100
Laurence Mathivon, +33 01 64 35 14 35, vsmadapathagesenanayake@ghef.fr
- Recruiting
CHR Metz-Thionville
Metz, 57000
Elodie Berson, +33 (0) 3 57 84 22 28, elodie.berson@uneos.fr
- Recruiting
CHU de Montpellier
Montpellier, 34090
Manal Al Masri, +33 (0) 4 67 45 73 16, manal_almasri@yahoo.com
- Recruiting
Clinique Saint Jean de Védas
Montpellier, 34430
Julie Soulier, +33 (0) 4 67 61 20 71, julie.soulier@capsante.fr
- Recruiting
Hôpitaux Pédiatriques de Nice CHU Lenval
Nice, 06200
Angelika Zieminski, +33 04 92 03 00 06, angelika.zieminski@hpu.lenval.com
- Recruiting
CHU Nîmes
Nîmes, 30029
Hasna Alla, +33 04 66 68 53 28, Hasna.ALLA@chu-nimes.fr
- Recruiting
Institut St-Pierre
Palavas-les-Flots, 34250
Mérédith Mercier
04 67 07 75 56, MERCIER.M@institut-st-pierre.fr
- Recruiting
Hôpital Lariboisière
Paris, 75010
Djamila Bellili, +33 (0) 1 49 95 90 15, djamila.bellili@aphp.fr
- Recruiting
Hôpital St-Antoine (APHP)
Paris, 75012
Camille Vatier, +33 01 71 97 09 78, camille.vatier@aphp.fr
- Recruiting
GH Paris Saint-Joseph
Paris, 75014
Nawal Amor, +33 01 44 12 74 63, namor@ghpsj.fr
- Recruiting
Hôpital Européen Georges Pompidou (APHP)
Paris, 75015
Zahia Hadidi, +33 01 56 09 50 32
zahia.hadidi@aphp.fr
- Recruiting
Hôpital Robert Debré
Paris, 75019
Caroline Arnaud-Sarthou, +33 06 95 61 08 09, caroline.taillandiersarthou@aphp.fr
- Recruiting
CH de Périgueux
Périgueux, 24000
Aude Angelescu, +33 05 53 45 25 25, aude.angelescu@ch-perigueux.fr
- Recruiting
MSP Les Belles Fleurs
Saint-Cyr-sur-Loire, 37540
Magali Lecoutre, +33 02 47 05 60 50, magalilecoutre@gmail.com
- Recruiting
CHRU Strasbourg
Strasbourg, 67000
Samir Chenaf, +33 03 88 12 82 07, samir.chenaf@chru-strasbourg.fr
- Recruiting
Clinique Pasteur Toulouse
Toulouse, 31300
Mathilde Pistre, +33 05 62 21 38 84, mpistre@clinique-pasteur.com
- Recruiting
CHU Toulouse
Toulouse, 31403
Laurent Cazals, +33 05 61 77 72 29, ecazals.l@chu-toulouse.fr
- Recruiting
CHU Tours
Tours, 37000
Sophie Gounin, +33 2 47 47 75 43, S.GOUNIN@chu-tours.fr
About this study
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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- t:slim X2 insulin pump with Control-IQ technology (Control-IQ System)
- Keywords
- Control-IQ, t:slim X2 insulin pump, Control-IQ technology, DKA, severe hypoglycemia, automated insulin dosing, automated insulin delivery, quality of life, type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control-IQ System | Participants will use the Control-IQ System as per standard of care. Receives: Device: t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Treatment Satisfaction
To evaluate treatment satisfaction based on the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) scores at baseline through 12 months.
Measured: 12 months
System Usability
To evaluate treatment satisfaction based on the System Usability Scale (SUS) scores at baseline through 12 months.
Measured: 12 months
Quality of Life Change
To evaluate change in quality of life based on the EQ-5D scores at baseline through 12 months.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start3 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tandem Diabetes Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre Riveline, MD, PhD, Principal investigator, Centre Universitaire du diabète et de ses complications, APHP, Hôpital Lariboisière, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211126
- Sponsor's protocol ID
- TP-0018999
- Acronym
- RECORD-IQ
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No