RecruitingPHASE2, PHASE3INTERVENTIONAL

Alleviating Carbohydrate Counting for Patients with Type-1 Diabetes Using a Closed Loop System with Weekly Subcutaneous Semaglutide

This study is investigating if a weekly injection called Semaglutide, used alongside an automated insulin delivery system (often called an 'artificial pancreas'), can simplify life for people with Type 1 Diabetes. The main idea is to see if participants can maintain good blood sugar control without having to carefully count carbohydrates at every meal. Semaglutide is already used for Type 2 Diabetes and weight loss, and this research explores its potential benefits for Type 1 Diabetes when combined with advanced insulin delivery. The study compares Semaglutide with a dummy drug (placebo) to understand its impact on managing blood sugar levels, helping people to spend more time in their target range.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrolment target

Start

01 Dec 2024

Estimated completion

01 Jan 2027

Type 1 Diabetes Diabetes Mellitus

What is this study about?

Imagine a system that helps manage your Type 1 Diabetes by automatically adjusting your insulin, much like an 'artificial pancreas.' This system uses an insulin pump and a continuous glucose monitor to keep your blood sugar levels in check. While this technology has been very helpful, counting carbohydrates for every meal can still be a big task every day.

This study is looking at a medication called Semaglutide, which is given as a weekly injection. Semaglutide helps with blood sugar in several ways, like slowing down how quickly food leaves your stomach and reducing appetite. It's currently used for people with Type 2 Diabetes and for weight loss. Researchers want to find out if adding Semaglutide to an 'artificial pancreas' system can make managing Type 1 Diabetes even easier, particularly by reducing or even removing the need to count carbs for every meal.

The main goal is to see if, with Semaglutide and the 'artificial pancreas,' people can spend just as much time (or more) within their healthy blood sugar range, even if they're not counting carbs as strictly. The study will also look at whether a faster-acting insulin combined with Semaglutide could allow for better blood sugar control without any meal announcements at all.

Key takeaways

This study explores a new way to manage Type 1 Diabetes.
It combines an 'artificial pancreas' system with a weekly injection called Semaglutide.
The main goal is to reduce or remove the need for carbohydrate counting.
You'll cycle through different meal strategies and receive either Semaglutide or a placebo.
The study lasts about 50 weeks and requires continuous use of an automated insulin delivery system.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with Type 1 Diabetes for at least one year. You also need to have been using a commercial automated insulin delivery system (like an 'artificial pancreas') for at least three months.

There are some reasons why you might not be able to join. For example, if you're pregnant, breastfeeding, or planning to become pregnant, this study isn't suitable. You also can't have participated in a similar study using GLP-1 medications in the last four weeks.

Other reasons you might not be able to join include having severe low blood sugar or diabetic ketoacidosis recently, or if you have a history of certain conditions like pancreatitis or specific thyroid cancers. The study team will check your medical history carefully to make sure it's safe for you to take part.

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.

Are you 18 years old or older?
Have you had Type 1 Diabetes for at least one year?
Do you use an automated insulin delivery system regularly (for 3+ months)?
Are you not pregnant, breastfeeding, or planning a pregnancy soon?
Do you not have a recent history of severe low blood sugar or diabetic ketoacidosis?
Do you not have certain other serious health conditions, especially related to the stomach, kidneys, or thyroid?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be involved for about 50 weeks. During this time, you'll receive two different treatments, one after the other, without knowing which one you're getting at any particular time (this is called 'blinded'). One treatment will be weekly injections of Semaglutide, and the other will be weekly injections of a dummy drug (a placebo). Each treatment period will involve four different ways of managing your meals, each lasting three weeks.

These meal strategies include carefully counting carbohydrates with regular insulin, making simple meal announcements with regular insulin, making simple meal announcements with a faster-acting insulin, and a fully automated system with faster-acting insulin where you don't make any meal announcements. You'll switch between these strategies and the two different injection types over the course of the study. You'll have regular check-ups and assessments to monitor your blood sugar control and general health throughout.

Potential risks and benefits

Taking part in a study like this could bring some potential benefits, such as improved blood sugar control and the possibility of a simpler way to manage your Type 1 Diabetes, especially regarding carbohydrate counting. However, as with any medication, Semaglutide can have side effects, and some people may experience issues like sickness or stomach upset. There's also a chance you'll receive the placebo, which won't have the active drug. The study team will carefully monitor you for any side effects or discomfort. You are always in control and have the full right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Research Institute of the McGill University Health Centre
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is an 'artificial pancreas' system?

It's an automated system that uses an insulin pump and a sensor to continuously monitor your blood sugar and automatically adjust your insulin dose.

What is Semaglutide?

Semaglutide is a weekly injectable medication that helps control blood sugar and can also help with weight loss. It's currently used for Type 2 Diabetes and obesity.

Will I know if I'm getting Semaglutide or a dummy drug?

No, this is a 'blinded' study, meaning neither you nor the study team will know which treatment you are receiving until the study is over.

How long will I be in the study?

The study will last for approximately 50 weeks, including different treatment and meal strategy periods.

What does 'eliminating carbohydrate counting' mean?

It means you wouldn't need to meticulously count the carbohydrates in your food, which could make diabetes management simpler for you.

How to find out more

Gabrielle Kemp, Registered Nurse

gabrielle.kemp@rimuhc.ca (438) 886-2171 Official trial record

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