DiabetesOPTIMAL-ANCT07039942

French Prospective Multicentric Study in Real World

An observational study of Diabetes and Diabetes Mellitus, run by Insulet Corporation at 24 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

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, Diabetes Mellitus, Type 1 Diabetes
What is being tested?: Omnipod 5
Type of treatment: Injection or infusion, Medical device
How many people: 304 participants
Where: 24 sitesFrance
Study dates: 23 Jul 2025to 30 Jul 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 Dexcom sensor (Dexcom G6 or Dexcom G7) in France.

Who may be able to join

Patient with T1D aged ≥ 2 years.
Patient prescribed a commercially available configuration of the Omnipod 5 System using a Dexcom sensor (Dexcom G6 or Dexcom G7).
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.
Patient or legal guardian (for minors) is not able to understand and complete electronic questionnaires.
Adult under guardianship, curatorship or tutorship.
Adult otherwise deprived of liberty.

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

France24 sites

CHU Angers
Angers, 49100
CHU Besançon - Hôpital de Jean Minjoz
Besançon
APHP Hopital Avicenne
Bobigny, 93000
CHU Bordeaux - Hôpital Pellegrin
Bordeaux, 33000
CHU Bordeaux - Hôpital St-André
Bordeaux, 33000
CHU BresCHU Brest - Hôpital de la Cavale Blanchet - Hôpital de la Cavale Blanche
Brest, 29200
Hôpital Femme Mère Enfant
Bron, 39500
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100
CHU Dijon - Hôpital François MitterrandCHU Dijon - Hôpital François Mitterrand
Dijon
GH La Rochelle-Ré-Aunis - Hôpital Saint Louis
La Rochelle, 17019
APHP Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Diab-eCare
Lyon, 69008
Institut de Diabétologie et de Nutrition du Centre
Mainvilliers, 28300
Fondation Ambroise Paré - Hôpital Européen de Marseille
Marseille
CHU Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, 34090
CHU Montpellier - Hôpital Lapeyronie
Montpellier, 34090
CHU Orléans
Orléans, 45100
APHP Hôpital Lariboisière
Paris, 75010
APHP La Pitié Salpêtrière
Paris, 75013
Hôpital NECKER
Paris, 75015
APHP Hopital Robert Debré
Paris, 75019
CH Périgueux
Périgueux, 24000
Cabinet Médical Saint-Cyr sur Loire
Saint-Cyr-sur-Loire, 37540
CHRU Strasbourg
Strasbourg, 67200

Other trials in France

About this study

Official title: Omnipod 5 - A French Prospective Multicentric Study in Real World

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 one of the Dexcom (Dexcom G6 or G7) configurations commercially available of the Omnipod 5 Automated Insulin Delivery System in France.

OPTIMAL-A 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, Diabetes Mellitus, Type 1 Diabetes
Being tested: Omnipod 5
Keywords: Type 1 Diabetes, Omnipod, Automated Insulin Delivery, 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 groups in NCT07039942
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 (TIR)
Assess the effectiveness of the Omnipod 5 system in terms of glycemic control
Measured: 12 months following first initiation of automated mode

Secondary outcomes (37)

Percentage of time in the 70 - 180 mg/dL range (TIR)
Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control
Measured: Up to 12-months following first initiation of automated mode
Percentage of time in the 70 - 140 mg/dL range (TIR Tight)
Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control
Measured: Up to 12-months following first initiation of automated mode
Percentage of time below 54 mg/dL (TBR Very Low)
Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control
Measured: Up to 12-months following first initiation of automated mode
Percentage of time below 70 mg/dL (TBR Low)
Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control
Measured: Up to 12-months following first initiation of automated mode
Percentage of time above 180 mg/dL (TAR High)
Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control
Measured: Up to 12-months following first initiation of automated mode
Percentage of time above 250 mg/dL (TAR Very High)
Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control
Measured: Up to 12-months following first initiation of automated mode
Glucose Management Indicator (GMI)
Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control
Measured: Up to 12-months following first initiation of automated mode
Glycemic Risk Index (GRI)
Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control
Measured: Up to 12-months following first initiation of automated mode
Coefficient of variation (CV)
Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control
Measured: Up to 12-months following first initiation of automated mode
Mean glucose
Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control
Measured: Up to 12-months following first initiation of automated mode
Laboratory HbA1c levels (if available)
Assess the sustained effectiveness of the Omnipod 5 system in terms of glycemic control
Measured: Up to 12-months following first initiation of automated mode
Percentage of patients with ≥ 70% TIR
Assess the achievement of CGM-based consensus targets
Measured: Up to 12-months following first initiation of automated mode
Percentage of patients with < 4% TBR Low
Assess the achievement of CGM-based consensus targets
Measured: Up to 12-months following first initiation of automated mode
Percentage of patients with < 1% TBR Very Low
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 QoL
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
Assess patients' diabetes-specific QoL
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 QoL
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
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
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 patients' satisfaction with the Omnipod 5 System
Measured: At inclusion and 6 and 12 months following first initiation of automated mode
Pediatric quality of life questionnaire (animated emoji scale - ad hoc)
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.

23 Jul 202530 Jul 2027

First posted26 Jun 2025
Study start23 Jul 2025
Primary completion30 Jul 2027 (estimated)
Study completion30 Jul 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: 304 participants (estimated)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT07039942
Sponsor's protocol ID: OPTIMAL-A
Acronym: OPTIMAL-A
Status last verified: Jul 2026
First submitted: 18 Jun 2025
Last updated: 3 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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
ClinicalTrials.gov ID: NCT07039942
Acronym / sponsor ID: OPTIMAL-A / OPTIMAL-A
Conditions: Diabetes, Diabetes Mellitus, Type 1 Diabetes
Keywords: Type 1 Diabetes, Omnipod, Automated Insulin Delivery, Registry
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 304 participants (estimated)
Lead sponsor: Insulet CorporationIndustry (pharma, biotech, devices)
Study start: 23 Jul 2025 (actual)
Primary completion: 30 Jul 2027 (estimated)
Study completion: 30 Jul 2027 (estimated)
First posted: 26 Jun 2025 (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.

Detailed description

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 Dexcom sensor (Dexcom G6 or Dexcom G7) in France.

Key inclusion criteria (8 listed)

Patient with T1D aged ≥ 2 years.
Patient prescribed a commercially available configuration of the Omnipod 5 System using a Dexcom sensor (Dexcom G6 or Dexcom G7).
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 (7 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.
Patient or legal guardian (for minors) is not able to understand and complete electronic questionnaires.

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 (TIR)
Time frame: 12 months following first initiation of automated mode
Assess the effectiveness of the Omnipod 5 system in terms of glycemic control

37 secondary outcomes

Percentage of time in the 70 - 180 mg/dL range (TIR)
Time frame: Up to 12-months following first initiation of automated mode
Percentage of time in the 70 - 140 mg/dL range (TIR Tight)
Time frame: Up to 12-months following first initiation of automated mode
Percentage of time below 54 mg/dL (TBR Very Low)
Time frame: Up to 12-months following first initiation of automated mode
Percentage of time below 70 mg/dL (TBR Low)
Time frame: Up to 12-months following first initiation of automated mode
Percentage of time above 180 mg/dL (TAR High)
Time frame: Up to 12-months following first initiation of automated mode
Percentage of time above 250 mg/dL (TAR Very High)
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
Laboratory HbA1c levels (if available)
Time frame: Up to 12-months following first initiation of automated mode
Percentage of patients with ≥ 70% TIR
Time frame: Up to 12-months following first initiation of automated mode
Percentage of patients with < 4% TBR Low
Time frame: Up to 12-months following first initiation of automated mode
Percentage of patients with < 1% TBR Very Low
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
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 (animated emoji scale - ad hoc)
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. This study is not recruiting at the moment.

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 Diabetes Mellitus, 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 7 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: under way, not looking for participants, 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 (TIR) (time frame: 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?

On the ClinicalTrials.gov record for NCT07039942.

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.