DiabetesNCT07317102
Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
An observational study of Diabetes and Type 1 Diabetes, run by Insulet Corporation at 24 sites in France.
Trial summary
The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Diabetes, Type 1 Diabetes, Diabetes Mellitus
- What is being tested?
- Omnipod 5
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 152 participants
- Where
- 24 sitesFrance
- Study dates
- 16 Mar 2026to Nov 2027
- How long will I take part?
- 12 Months
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population contains patients (age ≥ 2 years) with T1DM initiating a commercially available configuration of the Omnipod 5 System using a FreeStyle Libre 2Plus in France.
Who may be able to join
- Patient with T1D aged ≥ 2 years.
- Patient prescribed, less than a year ago, a commercially available confi guration of the Omnipod 5 System using a FreeStyle Libre 2 Plus sensor.
- Patient has never used the Omnipod 5 System prior to inclusion.
- Patient has not objected to the use of their personal data for this study.
- Patient or legal guardian has an email address and mobile phone number.
- Patient (and legal guardians if the patient is a minor) is able to understand study information and Non-Opposition form.
- Patient (and legal guardians if the patient is a minor) is able to understand and complete questionnaires in French.
- Patient is covered by the local social security system
Who cannot join
- Patient is currently pregnant.
- Patient presents an allergy to the materials of the Omnipod 5 System (patch, cannula, CGM).
- Patient is unable to be followed by the same investigation site for the duration of the study or is unwilling or unable to maintain contact with the healthcare professional.
- Patient is already participating in a clinical trial or in another study precluding their participation in other studies.
- Adult under guardianship, curatorship or tutorship.
- Adult otherwise deprived of liberty.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
France24 sites, 24 recruiting
- Recruiting
CHU Angers
Angers, 49100
Lucie DUFOUR
Regis COUTANT
- Recruiting
CHU Besançon - Hôpital de Jean Minjoz
Besançon, 25000
Julie GUCCIARDI
Sophie BOROT
- Recruiting
APHP Hopital Avicenne
Bobigny, 93000
Sarah YAHIAOUI
Emmanuel COSSON
- Recruiting
CHU Bordeaux - Hôpital Pellegrin
Bordeaux, 33000
Caroline BOUYSSOU
Sandra POCHELU
- Recruiting
CHU Bordeaux - Hôpital St-André
Bordeaux, 33000
Bogdan CATARGI
Bogdan CATARGI
- Recruiting
CHU Brest - Hôpital de la Cavale Blanche
Brest, 29200
Pascale Quiniou
Emmanuel SONNET
- Recruiting
Hôpital Femme Mère Enfant
Bron, 39500
Karima RENDJA
Kevin PERGE
- Recruiting
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100
Catherine PETIT
Alfred PENFORNIS
- Recruiting
CIRDIA
Dijon, 21000
Sylvie PICARD
Sylvie PICARD
- Recruiting
CHU Dijon - Hôpital François Mitterrand
Dijon
Isabelle SIMONEAU
Bruno VERGES
- Recruiting
GH La Rochelle-Ré-Aunis - Hôpital Saint Louis
La Rochelle, 17019
Harivola ANDRIANTAOLO
Didier GOUET
- Not yet recruiting
APHP Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Christelle Audrain, 01-452-17-117, christelle.audrain@aphp.fr
Cecile Petit-Bibal
- Recruiting
Institut de Diabétologie et de Nutrition du Centre
Mainvilliers, 28300
Eva BRIAND
Said BEKKA
- Recruiting
Fondation Ambroise Paré - Hôpital Européen de Marseille
Marseille
Audrey OLIVETTI
Pauline SCHAEPELYNCK
- Recruiting
CHU Montpellier - Hôpital Lapeyronie
Montpellier, 34090
Manal AL MASRI-SHBAT
Eric RENARD
- Recruiting
CHU Nantes
Nantes
Audrey ERNOULD, 02 53 48 27 26, Audrey.ERNOULD@chu-nantes.fr
Lucy CHAILLOUS
- Recruiting
Institut Saint Pierre
Palavas-les-Flots, 34250
Chrystel LEPERCHOIS
Fabienne DALLA VALE
- Recruiting
APHP Hôpital Lariboisière
Paris, 75010
Charline POTIER
Jean-Pierre RIVELINE
- Recruiting
APHP Hopital Robert Debré
Paris, 75019
Caroline ARNAUD-SARTHOU
Elise BISMUTH
- Recruiting
APHP Hôpital Saint-Antoine
Paris
Yasmina SAIDI, 06 62 32 22 91, yasmina.saidi@aphp.fr
Camille VATIER
- Recruiting
CH Périgueux
Périgueux, 24000
Aude ANGELESCU
Christine COFFIN
- Recruiting
Clinique Saint Jean de Védas
Saint-Jean-de-Védas, 34430
Mérédith MERCIER
Elizabeth BONNEMAISON
- Recruiting
CHRU Strasbourg
Strasbourg, 67098
Samir CHENAF
Nathalie JEANDIDIER
- Recruiting
CHU Tours
Tours, 37000
Sophie GOUNIN
Yannis CHARTIER
About this study
The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.
Read the detailed description
Twelve-month, real-world, non-interventional, prospective follow-up of adult and pediatric patients aged more than 2 years old, prescribed the commercially available FreeStyle Libre 2 Plus configuration of the Omnipod 5 Automated Insulin Delivery System in France.
OPTIMAL-B study (Omnipod 5 - A French Prospective Multicentric Study in Real World), aims to provide the requisite real-world data on the glycemic control, quality of life, safety, and device usage profiles of users of the Omnipod 5 System during the 12 months after starting using Omnipod 5 in automated mode.
- Conditions
- Diabetes, Type 1 Diabetes, Diabetes Mellitus
- Being tested
- Omnipod 5
- Keywords
- Omnipod, Automated Insulin Delivery, Post-market Registry
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnipod 5Device
The Omnipod 5 Automated Insulin Delivery System (Omnipod 5 System) is a tubeless insulin pump with a mono-hormonal insulin delivery system designed to deliver U-100 insulin subcutaneously for the management of type 1 diabetes in people aged 2 years and older who require insulin.
The Omnipod 5 System is intended to function as an automated insulin delivery system when used with compatible Continuous Glucose Monitoring (CGM) systems.
| Study group | Role | What they receive |
|---|---|---|
| Omnipod 5 User | Participation of each patient begins at inclusion and continues until the end-of-study visit, 12 months (± 1 month) following first initiation of automated mode of the Omnipod 5 System Receives: Device: Omnipod 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the percentage of time in the 70 - 180 mg/dL range
Glucose metric from continuous glucose monitoring system to assess glucose control
Measured: Change in percentage of time in specified range between Baseline and 12-months following first initiation of automated mode
Secondary outcomes (37)
Percentage of time in the 70 - 180 mg/dL range
Glucose metric from continuous glucose monitoring system to assess glucose control
Measured: Up to 12-months following first initiation of automated mode
Percentage of time in the 70 - 140 mg/dL range
Glucose metric from continuous glucose monitoring system to assess glucose control
Measured: Up to 12-months following first initiation of automated mode
Percentage of time below 54 mg/dL
Glucose metric from continuous glucose monitoring system to assess glucose control
Measured: Up to 12-months following first initiation of automated mode
Percentage of time below 70 mg/dL
Glucose metric from continuous glucose monitoring system to assess glucose control
Measured: Up to 12-months following first initiation of automated mode
Percentage of time above 180 mg/dL
Glucose metric from continuous glucose monitoring system to assess glucose control
Measured: Up to 12-months following first initiation of automated mode
Percentage of time above 250 mg/dL
Glucose metric from continuous glucose monitoring system to assess glucose control
Measured: Up to 12-months following first initiation of automated mode
Glucose Management Indicator (GMI)
Glucose metric from continuous glucose monitoring system to assess glucose control
Measured: Up to 12-months following first initiation of automated mode
Glycemic Risk Index (GRI)
Glucose metric from continuous glucose monitoring system to assess glucose control
Measured: Up to 12-months following first initiation of automated mode
Coefficient of variation (CV)
Glucose metric from continuous glucose monitoring system to assess glucose control
Measured: Up to 12-months following first initiation of automated mode
Mean glucose
Glucose metric from continuous glucose monitoring system to assess glucose control
Measured: Up to 12-months following first initiation of automated mode
HbA1c Level (if available)
Blood test to assess glucose control
Measured: Up to 12-months following first initiation of automated mode
Percentage of patients with ≥ 70%
Assess the achievement of CGM-based consensus targets
Measured: Up to 12-months following first initiation of automated mode
Percentage of patients with < 4%
Assess the achievement of CGM-based consensus targets
Measured: Up to 12-months following first initiation of automated mode
Percentage of patients with < 1%
Assess the achievement of CGM-based consensus targets
Measured: Up to 12-months following first initiation of automated mode
Percentage of patients with GMI ≤ 7%
Assess the achievement of CGM-based consensus targets
Measured: Up to 12-months following first initiation of automated mode
Percentage of patients with CV ≤ 36%
Assess the achievement of CGM-based consensus targets
Measured: Up to 12-months following first initiation of automated mode
Percentage of patients achieving combinations of previous CGM-based consensus targets
Assess the achievement of CGM-based consensus targets
Measured: Up to 12-months following first initiation of automated mode
EuroQoL 5-dimension 5-level questionnaire
Assess patients' general quality of life
Measured: At inclusion and 6 and 12 months following first initiation of automated mode
Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL)
Assess patients' diabetes-specific quality of life on a scale of very satisfied to very dissatisfied
Measured: At inclusion and 6 and 12 months following first initiation of automated mode
Patients aged 10-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)
Assess patients' diabetes-specific quality of life on a scale of 0 (never) to 4 (all the time)
Measured: At inclusion and 6 and 12 months following first initiation of automated mode
Insulin Delivery System Rating Questionnaire (IDSRQ) interference sub-score
Assess the interference of the Omnipod 5 System with patients' daily lives
Measured: At inclusion and 6 and 12 months following first initiation of automated mode
Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs)
Assess patients' satisfaction with the Omnipod 5 System on a scale of 0 (very dissatisfied) to 6 (very satisfied)
Measured: At inclusion and 6 and 12 months following first initiation of automated mode
Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire, status version -Teens (DTSQs - Teen)
Assess patients' satisfaction with the Omnipod 5 System on a scale of 0 (very dissatisfied) to 6 (very satisfied)
Measured: At inclusion and 6 and 12 months following first initiation of automated mode
Patients aged 2-12 years: Diabetes Treatment Satisfaction Questionnaire, status version -Parent (DTSQs - Parent)
Assess satisfaction with the Omnipod 5 System on a scale of 0 (very dissatisfied) to 6 (very satisfied)
Measured: At inclusion and 6 and 12 months following first initiation of automated mode
Pediatric quality of life questionnaire
Assess pediatric patients' quality of life with the Omnipod 5 System
Measured: At inclusion and 6 and 12 months following first initiation of automated mode
Percentage of time using the System in automated mode
Describe System use
Measured: 12 months following first initiation of automated mode
Percentage of time using the System in manual mode
Describe System use
Measured: 12 months following first initiation of automated mode
Percentage of time using "Activity" feature
Describe System use
Measured: 12 months following first initiation of automated mode
Total daily dose of insulin
Describe System use
Measured: 12 months following first initiation of automated mode
Number of boluses per day
Describe System use
Measured: 12 months following first initiation of automated mode
Targets used by patients
Describe System use
Measured: 12 months following first initiation of automated mode
Bolus/Basal distribution
Describe System use
Measured: 12 months following first initiation of automated mode
Incidence of severe hypoglycemia
Assess the incidence and type of acute metabolic complications
Measured: 6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode
Incidence of diabetic ketoacidosis
Assess the incidence and type of acute metabolic complications
Measured: 6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode
Unscheduled hospitalizations for diabetes or diabetes complications
Assess the incidence and type of acute metabolic complications
Measured: 6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode
Percentage of patients still using the Omnipod 5 System at the end of study follow-up
Assess the rate at which patients stop using the Omnipod 5 system
Measured: 12 months following first initiation of automated mode
Reasons for having stopped using the Omnipod 5 System
Assess the rate at which patients stop using the Omnipod 5 system
Measured: 12 months following first initiation of automated mode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start16 Mar 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- 152 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Insulet Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre Riveline, MD, PhD, Principal investigator, Centre Universitaire du Diabète et ses complications Hôpital Lariboisière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317102
- Sponsor's protocol ID
- Optimal-B
- Status last verified
- Jul 2026
- First submitted
- 18 Dec 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
- ClinicalTrials.gov ID
- NCT07317102
- Acronym / sponsor ID
- Optimal-B
- Conditions
- Diabetes, Type 1 Diabetes, Diabetes Mellitus
- Keywords
- Omnipod, Automated Insulin Delivery, Post-market Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Insulet CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.
Detailed description
Twelve-month, real-world, non-interventional, prospective follow-up of adult and pediatric patients aged more than 2 years old, prescribed the commercially available FreeStyle Libre 2 Plus configuration of the Omnipod 5 Automated Insulin Delivery System in France.
OPTIMAL-B study (Omnipod 5 - A French Prospective Multicentric Study in Real World), aims to provide the requisite real-world data on the glycemic control, quality of life, safety, and device usage profiles of users of the Omnipod 5 System during the 12 months after starting using Omnipod 5 in automated mode.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omnipod 5 User | – | Device: Omnipod 5Participation of each patient begins at inclusion and continues until the end-of-study visit, 12 months (± 1 month) following first initiation of automated mode of the Omnipod 5 System |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population contains patients (age ≥ 2 years) with T1DM initiating a commercially available configuration of the Omnipod 5 System using a FreeStyle Libre 2Plus in France.
Key inclusion criteria (8 listed)
- Patient with T1D aged ≥ 2 years.
- Patient prescribed, less than a year ago, a commercially available confi guration of the Omnipod 5 System using a FreeStyle Libre 2 Plus sensor.
- Patient has never used the Omnipod 5 System prior to inclusion.
- Patient has not objected to the use of their personal data for this study.
- Patient or legal guardian has an email address and mobile phone number.
Key exclusion criteria (6 listed)
- Patient is currently pregnant.
- Patient presents an allergy to the materials of the Omnipod 5 System (patch, cannula, CGM).
- Patient is unable to be followed by the same investigation site for the duration of the study or is unwilling or unable to maintain contact with the healthcare professional.
- Patient is already participating in a clinical trial or in another study precluding their participation in other studies.
- Adult under guardianship, curatorship or tutorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omnipod 5The Omnipod 5 Automated Insulin Delivery System (Omnipod 5 System) is a tubeless insulin pump with a mono-hormonal insulin delivery system designed to deliver U-100 insulin subcutaneously for the management of type 1 diabetes in people aged 2 years and older who require insulin. The Omnipod 5 System is intended to function as an automated insulin delivery system when used with compatible Continuous Glucose Monitoring (CGM) systems. | Device | Omnipod 5 User |
Primary outcome
Change in the percentage of time in the 70 - 180 mg/dL range
Time frame: Change in percentage of time in specified range between Baseline and 12-months following first initiation of automated mode
Glucose metric from continuous glucose monitoring system to assess glucose control
37 secondary outcomes
Percentage of time in the 70 - 180 mg/dL range
Time frame: Up to 12-months following first initiation of automated mode
Percentage of time in the 70 - 140 mg/dL range
Time frame: Up to 12-months following first initiation of automated mode
Percentage of time below 54 mg/dL
Time frame: Up to 12-months following first initiation of automated mode
Percentage of time below 70 mg/dL
Time frame: Up to 12-months following first initiation of automated mode
Percentage of time above 180 mg/dL
Time frame: Up to 12-months following first initiation of automated mode
Percentage of time above 250 mg/dL
Time frame: Up to 12-months following first initiation of automated mode
Glucose Management Indicator (GMI)
Time frame: Up to 12-months following first initiation of automated mode
Glycemic Risk Index (GRI)
Time frame: Up to 12-months following first initiation of automated mode
Coefficient of variation (CV)
Time frame: Up to 12-months following first initiation of automated mode
Mean glucose
Time frame: Up to 12-months following first initiation of automated mode
HbA1c Level (if available)
Time frame: Up to 12-months following first initiation of automated mode
Percentage of patients with ≥ 70%
Time frame: Up to 12-months following first initiation of automated mode
Percentage of patients with < 4%
Time frame: Up to 12-months following first initiation of automated mode
Percentage of patients with < 1%
Time frame: Up to 12-months following first initiation of automated mode
Percentage of patients with GMI ≤ 7%
Time frame: Up to 12-months following first initiation of automated mode
Percentage of patients with CV ≤ 36%
Time frame: Up to 12-months following first initiation of automated mode
Percentage of patients achieving combinations of previous CGM-based consensus targets
Time frame: Up to 12-months following first initiation of automated mode
EuroQoL 5-dimension 5-level questionnaire
Time frame: At inclusion and 6 and 12 months following first initiation of automated mode
Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL)
Time frame: At inclusion and 6 and 12 months following first initiation of automated mode
Patients aged 10-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)
Time frame: At inclusion and 6 and 12 months following first initiation of automated mode
Insulin Delivery System Rating Questionnaire (IDSRQ) interference sub-score
Time frame: At inclusion and 6 and 12 months following first initiation of automated mode
Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs)
Time frame: At inclusion and 6 and 12 months following first initiation of automated mode
Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire, status version -Teens (DTSQs - Teen)
Time frame: At inclusion and 6 and 12 months following first initiation of automated mode
Patients aged 2-12 years: Diabetes Treatment Satisfaction Questionnaire, status version -Parent (DTSQs - Parent)
Time frame: At inclusion and 6 and 12 months following first initiation of automated mode
Pediatric quality of life questionnaire
Time frame: At inclusion and 6 and 12 months following first initiation of automated mode
Percentage of time using the System in automated mode
Time frame: 12 months following first initiation of automated mode
Percentage of time using the System in manual mode
Time frame: 12 months following first initiation of automated mode
Percentage of time using "Activity" feature
Time frame: 12 months following first initiation of automated mode
Total daily dose of insulin
Time frame: 12 months following first initiation of automated mode
Number of boluses per day
Time frame: 12 months following first initiation of automated mode
Targets used by patients
Time frame: 12 months following first initiation of automated mode
Bolus/Basal distribution
Time frame: 12 months following first initiation of automated mode
Incidence of severe hypoglycemia
Time frame: 6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode
Incidence of diabetic ketoacidosis
Time frame: 6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode
Unscheduled hospitalizations for diabetes or diabetes complications
Time frame: 6 months prior to switching to Omnipod 5 and over the 12 months following first initiation of automated mode
Percentage of patients still using the Omnipod 5 System at the end of study follow-up
Time frame: 12 months following first initiation of automated mode
Reasons for having stopped using the Omnipod 5 System
Time frame: 12 months following first initiation of automated mode
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Pierre Riveline, MD, PhD principal investigator
Centre Universitaire du Diabète et ses complications Hôpital Lariboisière
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Type 1 Diabetes, run by Insulet Corporation at 24 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 8 inclusion and 6 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 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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 Trang Ly, MBBS, PhD (978-600-7000, APClinical@insulet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the percentage of time in the 70 - 180 mg/dL range (time frame: Change in percentage of time in specified range between Baseline and 12-months following first initiation of automated mode). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026.