Not yet recruitingNAINTERVENTIONAL

REMIssion of Type 2 Diabetes Between Intermittently Scanned Continuous Glucose Monitoring and Capillary Blood Glucose Monitoring When Added to Low-calorie Meal Replacement and Diabetes Self-management Education

This research trial is for people with type 2 diabetes and aims to discover the best way to help them achieve remission. Participants will follow a low-calorie meal replacement plan and receive education on managing their diabetes. The main focus is to compare two methods of checking blood sugar: a small sensor called an 'intermittently scanned continuous glucose monitor' (which you scan yourself) versus traditional finger-prick blood glucose monitoring. Researchers want to see if one method helps more people reach remission from type 2 diabetes. Remission means your blood sugar levels are no longer in the diabetes range, often reducing or stopping diabetes medication. The study involves a planned diet, education, and monitoring over several months.

At a glance

Status

Not yet recruiting

Phase

Sponsor

LMC Diabetes & Endocrinology Ltd.

Enrolment target

176

Start

01 Sep 2025

Estimated completion

01 Jun 2027

Type 2 Diabetes

What is this study about?

This study is designed for adults living with type 2 diabetes and aims to find the most effective approach to help them put their diabetes into remission. Remission, in this context, means that your blood sugar levels return to a healthy range (either prediabetes or normal levels) without needing diabetes medication for at least three months. This could be a significant step towards better health and reducing the long-term impact of diabetes.

The trial combines two key strategies: a low-calorie meal replacement plan and diabetes self-management education. This education will provide you with important tools and knowledge to understand and manage your condition better. On top of these, the study will compare two different ways of checking blood sugar levels. One group will use a small device called an 'intermittently scanned continuous glucose monitor' (often called an 'isCGM'), which you wear and scan to see your blood sugar. The other group will use the more traditional 'capillary blood glucose monitoring,' which involves finger-prick tests.

The main goal is to see if using the isCGM helps more people achieve diabetes remission compared to finger-prick tests, when both are combined with the diet and education program. Participants will go through three main phases: an initial total meal replacement phase, followed by a gradual re-introduction of food, and finally a remission phase, all while receiving support and education over approximately 18 months. By understanding which monitoring method works best, doctors can offer more tailored and effective support to people with type 2 diabetes.

Key takeaways

This study aims to find the best way to help people with type 2 diabetes achieve remission.
It combines a low-calorie meal replacement diet and diabetes education.
Compares two ways of checking blood sugar: a small sensor (isCGM) vs. finger-prick tests.
Remission means healthy blood sugar levels, potentially without diabetes medication.
The study lasts about 18 months and involves different diet phases and education.
It could help improve care for people with type 2 diabetes in the future.

Who may be eligible?

This study is looking for adults aged 18 to 75 who have type 2 diabetes. You would need to have been diagnosed with type 2 diabetes between 6 months and 6 years ago, and your diabetes should not be managed with insulin (unless it was only for gestational diabetes during pregnancy).

Your recent blood sugar levels (HbA1c) should be within a certain range, depending on how many medications you currently take for your diabetes. Your Body Mass Index (BMI) also needs to be between 27 and 44.9. You shouldn't currently be using a continuous glucose monitor (CGM).

There are also some health conditions that would prevent you from taking part, such as certain heart, kidney, or eye problems, or if you are pregnant or breastfeeding. You also can't be taking certain medications like corticosteroids or some antipsychotics. The research team will review your full medical history to confirm if you are suitable.

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 between 18 and 75 years old?
Have you been diagnosed with type 2 diabetes within the last 6 months to 6 years?
Do you currently *not* use insulin for your diabetes (unless it was for pregnancy)?
Do you *not* currently use a continuous glucose monitor (CGM) or similar device?
Are you willing to follow a low-calorie meal replacement plan and attend education sessions?

Answer every question to see your result.

What does participation involve?

If you join this study, your participation will last for about 18 months. You’ll be randomly assigned to one of two groups: either using an intermittently scanned continuous glucose monitor (isCGM) or doing finger-prick blood sugar tests (capillary blood glucose monitoring).

Both groups will follow a low-calorie meal replacement plan, which means shakes or soups will replace your meals for a period, with gradual re-introduction of regular food. You will also attend diabetes self-management education sessions throughout the study. You'll have regular visits and assessments with the study team to monitor your progress, check your blood sugar levels, and ensure your safety and well-being. The study also involves following specific plans for your diet and sugar monitoring, as judged by the research team.

Potential risks and benefits

Taking part in this study could offer several potential benefits, such as potentially achieving remission from your type 2 diabetes, leading to better health, and reducing or stopping diabetes medication. You'll receive structured support through a low-calorie diet and diabetes education, which can improve your understanding and management of your condition. While overall risks are generally low, there are always potential risks associated with dietary changes or new monitoring devices, such as discomfort from the CGM sensor or potential side effects from the meal replacement plan. The research team will monitor you closely for any issues. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (6)

LMC Brampton
Verified postcode
Brampton, Canada
LMC Etobicoke
Verified postcode
Etobicoke, Canada
LMC Oakville
Verified postcode
Oakville, Canada
LMC Ottawa
Verified postcode
Ottawa, Canada
LMC Bayview
Verified postcode
Toronto, Canada
LMC Vaughan
Verified postcode
Vaughan, Canada

Common questions

What does 'remission' mean for type 2 diabetes?

Remission means your blood sugar levels are healthy again, below the diabetes range, often without needing diabetes medication for at least three months.

What is an 'intermittently scanned continuous glucose monitor' (isCGM)?

It's a small sensor you wear that continuously measures your blood sugar. You scan it with a device or smartphone to see your current level, much easier than finger-pricks.

Will I have to eat special food?

Yes, for part of the study, you'll follow a low-calorie meal replacement plan, using special shakes or soups, followed by a gradual return to regular food.

Do I have to stop my current diabetes medications?

The study design involves a low-calorie meal replacement plan which may lead to reductions in your diabetes medications. Your study doctor will manage your medications safely throughout the trial.

How long does the study last?

If you join, your involvement in the study will be for approximately 18 months.

How to find out more

Manager, Data Science

lisa.chu@lmc.ca 14166452929 Official trial record

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