RecruitingOBSERVATIONAL

French Prospective Multicentric Study in Real World

This study, called "OPTIMAL-A," is looking at how well the Omnipod 5 Automated Insulin Delivery System works for people with Type 1 diabetes in real life. It aims to understand blood sugar control, how it impacts their quality of life, and their overall satisfaction with the device. Researchers will also look at how often people experience diabetes complications and how they use the Omnipod 5 system. This is a 12-month study following adults and children aged 2 and older who are using a combined Omnipod 5 and Dexcom sensor system. It's happening in France and gathers information from people as they go about their daily lives, rather than in a special clinic setting.

At a glance

Status

Recruiting

Sponsor

Insulet Corporation

Enrolment target

304

Start

23 Jul 2025

Estimated completion

01 Oct 2027

Diabetes Diabetes Mellitus Type 1 Diabetes

What is this study about?

This research study, named OPTIMAL-A, is for people in France who have Type 1 diabetes and are using a new type of insulin pump system called Omnipod 5. This system works automatically with a special sensor (either Dexcom G6 or G7) to help manage blood sugar levels through the day. The main goal of this study is to see how well this system helps people control their diabetes in their everyday lives, outside of a special hospital setting. They want to understand if it leads to better blood sugar readings, and how it affects people's general well-being and happiness with their treatment.

The researchers will be following participants for 12 months. During this time, they will gather information on how the Omnipod 5 system is being used, if it reduces frustrating diabetes complications, and how people feel about their overall quality of life with the device. This kind of "real-world" study is important because it shows how medical devices work for real people, in their homes and daily routines, which is different from how they might work in highly controlled research environments.

By gathering this information, healthcare professionals and device makers can better understand the benefits and challenges of using systems like Omnipod 5 for people with Type 1 diabetes. This can help them make improvements, provide better support, and inform treatment decisions in the future.

Key takeaways

It's a study looking at how Omnipod 5 helps people with Type 1 diabetes in France.
It's for people aged 2 and older using Omnipod 5 with a Dexcom sensor.
The study lasts for 12 months and follows participants in their normal lives.
Information will be gathered using questionnaires about blood sugar, quality of life, and satisfaction.
It's a 'real-world' study, meaning no special treatments or extra clinic visits are required.

Who may be eligible?

To be part of this study, you need to have Type 1 diabetes and be at least 2 years old. You must also be using the Omnipod 5 system along with either a Dexcom G6 or Dexcom G7 sensor in France. It's important that you haven't used the Omnipod 5 system before starting this study, and you should be happy for your personal health information to be used for research purposes.

You'll also need to have an email address and a mobile phone number. Both you (and your parents or guardians if you're under 18) must be able to understand the study information and fill out surveys in French. You also need to be covered by the French social security system.

There are some reasons why you might not be able to join. For example, if you are pregnant, have an allergy to any part of the Omnipod 5 system (like the patch or sensor), or are already taking part in another clinical trial. Also, if you aren't able to stay in touch with your healthcare team throughout the study, or if you can't fill out electronic questionnaires, you wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have Type 1 diabetes and am I 2 years old or older?
Am I using the Omnipod 5 system with a Dexcom G6 or G7 sensor?
Have I never used Omnipod 5 before starting this study?
Am I happy for my health information to be used for research?
Can I understand and complete questionnaires in French?
Am I not pregnant and do not have allergies to the Omnipod 5 materials?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be followed for a full 12 months. This is a "non-interventional" study, which means you'll continue using your Omnipod 5 system as prescribed by your doctor, just as you normally would. You won't be asked to change your treatment or visit special clinics for extra tests that aren't part of your usual care.

The main part of your participation will involve completing questionnaires. These surveys will ask about your blood sugar control, how the Omnipod 5 system affects your daily life, and your general satisfaction. You (or your guardians, if you're a child) will need to be able to understand and complete these questionnaires in French. You'll also need to stay in regular contact with your healthcare professional at the same clinic throughout the 12 months.

Potential risks and benefits

Taking part in this study may offer personal benefits, such as contributing to a better understanding of how the Omnipod 5 system works for people with Type 1 diabetes in real life, which could help others in the future. As you are already using the Omnipod 5 system as part of your normal care, there aren't many new risks usually associated with taking part in this specific study, beyond those linked to using the device itself. However, it's always important to discuss any concerns with your doctor. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (24)

CHU Angers
Verified postcode
Angers, France· Recruiting
CHU Besançon - Hôpital de Jean Minjoz
Verified postcode
Besançon, France· Recruiting
APHP Hopital Avicenne
Verified postcode
Bobigny, France· Recruiting
CHU Bordeaux - Hôpital Pellegrin
Verified postcode
Bordeaux, France· Recruiting
CHU Bordeaux - Hôpital St-André
Verified postcode
Bordeaux, France· Recruiting
CHU BresCHU Brest - Hôpital de la Cavale Blanchet - Hôpital de la Cavale Blanche
Verified postcode
Brest, France· Recruiting
Hôpital Femme Mère Enfant
Verified postcode
Bron, France· Recruiting
Centre Hospitalier Sud Francilien
Verified postcode
Corbeil-Essonnes, France· Recruiting
CHU Dijon - Hôpital François MitterrandCHU Dijon - Hôpital François Mitterrand
Verified postcode
Dijon, France· Recruiting
GH La Rochelle-Ré-Aunis - Hôpital Saint Louis
Verified postcode
La Rochelle, France· Recruiting
APHP Hôpital Bicêtre
Verified postcode
Le Kremlin-Bicêtre, France· Recruiting
Diab-eCare
Verified postcode
Lyon, France· Recruiting

Common questions

What is the Omnipod 5 system?

It's an automated insulin delivery system that works with a sensor to help manage blood sugar for people with Type 1 diabetes.

Who is running this study?

This study is being conducted by researchers in France, looking at real-world use of the Omnipod 5 system.

Do I have to change my diabetes treatment to join?

No, you don't. You'll continue using your Omnipod 5 system as prescribed by your doctor, just as you normally would.

What information will they collect from me?

They will collect information on your blood sugar control, quality of life, satisfaction with the device, and how you use the system.

How long will I be in the study?

The study will follow you for 12 months after you start using the Omnipod 5 system in automated mode.

How to find out more

Trang Ly, MBBS, PhD

apclinical@insulet.com 978-600-7000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.