AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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
Show all 10Show fewer
  • 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.

Arthur Senigout contact

+33 6 85 98 40 44

record-iq@sanoia.com

25 sites in 1 country

France25 sites, 25 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

    Recruiting

Other trials in France

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:

  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.
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 groups in NCT07211126
Study groupRoleWhat they receive
Control-IQ SystemParticipants 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.

  1. 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

  2. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Treatment Satisfaction

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

    Measured: 12 months

  7. System Usability

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

    Measured: 12 months

  8. 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

  9. 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

  10. 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.

  1. First posted7 Oct 2025
  2. Study start3 Mar 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 1, run by Tandem Diabetes Care, Inc. at 25 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Arthur Senigout (+33 6 85 98 40 44, record-iq@sanoia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of diabetic ketoacidosis (DKA). (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07211126.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in