RecruitingNAINTERVENTIONAL

Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes

This research is investigating whether an automated system, called a 'hybrid closed-loop' (HCL) system, can help children and teenagers who have recently been diagnosed with Type 1 diabetes. The study aims to see if starting this system soon after diagnosis leads to better blood sugar control compared to traditional insulin methods like daily injections or standard insulin pumps. Researchers will track how much time blood sugar levels stay in a healthy range, if there are fewer low or high blood sugar events, and if it makes managing diabetes less stressful for families. The study will last for at least one year, with an optional second year.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Montpellier

Enrolment target

112

Start

29 May 2024

Estimated completion

29 Jun 2027

Diabetes

What is this study about?

This study is about children and teenagers aged 2 to under 18 who have recently found out they have Type 1 diabetes. We know that managing diabetes can be tough, involving careful attention to blood sugar levels and insulin doses every day. This research aims to find out if using a new type of automated insulin system, called a 'hybrid closed-loop' system, soon after diagnosis can make a real difference.

The 'hybrid closed-loop' system works by connecting an insulin pump (OmniPod 5) with a continuous glucose monitor (Dexcom G6). This combination allows the system to automatically adjust insulin delivery based on blood sugar readings, hoping to keep levels more stable. The study will compare how well this automated system works against the usual insulin treatments, such as multiple daily injections or other insulin pumps, over a year. The main goal is to see if the automated system helps children and teens keep their blood sugar levels within a healthy range more often.

Beyond just blood sugar control, the study also checks other important things. This includes understanding if the automated system leads to fewer very low or very high blood sugar events, if blood sugar levels are more stable, and if it reduces the everyday stress of managing diabetes for families. There's also an optional second year to see if these benefits continue over a longer period and to compare starting the automated system early versus a year later.

Key takeaways

New study for children (2-18) recently diagnosed with Type 1 diabetes.
Compares an automated insulin system to standard diabetes care.
Aims for better blood sugar control and easier diabetes management.
Involves using a continuous glucose monitor (Dexcom G6).
Study lasts 1-2 years with regular check-ups.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

This study is looking for children and teenagers between 2 and 18 years old who have been diagnosed with Type 1 diabetes in the last 3 to 6 months. To join, they must already be using insulin, either through daily injections or an insulin pump. It's important that the child or their parents/guardians are able to count carbohydrates in meals. They also need to have a smartphone that can use the Dexcom G6 app and be happy to use this system throughout the study.

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.

Is your child between 2 and 18 years old?
Was your child diagnosed with Type 1 diabetes between 3 and 6 months ago?
Is your child currently using insulin (injections or pump)?
Can you or your child count carbohydrates in meals?
Do you have a smartphone that can download the Dexcom G6 app?
Are you happy to use sensors on the skin throughout the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a short 'run-in' period of about 30 days. During this time, everyone will learn how to use a continuous glucose monitor (Dexcom G6) to help guide their insulin doses. After this, participants will be randomly chosen, like flipping a coin, to either start using the new automated insulin system right away or continue with their usual insulin treatment (using injections or their standard insulin pump).

For those using the new system, you'll receive training on how it works. You'll have safety phone calls shortly after starting the system. Throughout the first year, everyone will have clinic visits every three months to check blood sugar control and ensure everything is working well. After one year, families in the usual care group will have the option to switch to the automated system, and those already on it can continue using it for an optional second year, with continued quarterly check-ups. The total duration of participation could be one or two years.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as receiving the new automated insulin system, which might lead to better blood sugar control and potentially make managing diabetes a bit easier. You'll also receive close monitoring and support from the study team. However, there are potential risks, including the usual challenges of managing diabetes, potential skin irritation from device adhesives, or the need to learn a new system. It's important to remember that all treatments have possible side effects, and this new system is still being studied. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

University Hospital, Angers
Verified postcode
Angers, France· Recruiting
University Hospital, Montpellier
Verified postcode
Montpellier, France· Recruiting
Robert Debré Hospital, AP-HP
Verified postcode
Paris, France· Recruiting
University Hospital, Tours
Verified postcode
Tours, France· Recruiting

Common questions

What is a 'hybrid closed-loop' system?

It's an automated system that connects an insulin pump to a continuous glucose monitor. It helps adjust insulin delivery automatically based on blood sugar readings.

Will my child have to change their diabetes treatment if they don't get the new system?

No, if your child is in the control group, they will continue with their current insulin treatment (injections or their usual pump) but will use the Dexcom G6 data to help manage their insulin.

How long will the study last?

The main part of the study lasts for one year, with an optional extra year for those who wish to continue.

What if my child has an allergic reaction to one of the devices?

The study has specific rules about this, and if a child has certain allergies, they might not be able to join. Please discuss any concerns with the study team.

Can I leave the study at any time?

Yes, you are free to withdraw your child from the study at any point, and it won't affect their regular medical care.

How to find out more

Eric RENARD, MD

e-renard@chu-montpellier.fr 04 67 33 83 82 Official trial record

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