RecruitingNAINTERVENTIONAL

Glucose Monitoring After Acute Myocardial Infarct in People With Diabetes

This study, funded by Dexcom, aims to understand if using a continuous glucose monitor (Dexcom ONE) helps people with type 2 diabetes manage their blood sugar levels after having a heart attack. Researchers want to see if keeping blood sugar within a healthy range helps improve health and reduce serious heart problems over a six-month period. Participants will be divided into two groups. One group will use the glucose monitor to see their blood sugar in real-time, receiving advice to help keep it stable. The other group will use monitors that hide the blood sugar information, only downloaded by the research team. This helps compare how seeing your blood sugar impacts health outcomes.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

160

Start

07 Feb 2023

Estimated completion

01 Feb 2025

Type 2 Diabetes Acute Myocardial Infarction Acute Myocardial Infarction With ST Elevation Diabetes Complications

What is this study about?

This study is looking into whether using a device called a continuous glucose monitor, specifically the Dexcom ONE, can help people with type 2 diabetes manage their blood sugar levels after they've had a heart attack. We know that controlling blood sugar is important for overall health, especially after a serious event like a heart attack.

The main goal of the study is to see if using this monitor helps people spend more time with their blood sugar levels in a healthy range during the six months after their heart attack. The researchers also want to explore if spending more time in this healthy blood sugar range could lead to fewer serious heart problems and even improve how long people live after a heart attack. This research is important because it could help doctors find better ways to care for people with diabetes after a heart attack.

Participants will be split into two groups. One group will get the Dexcom ONE monitor which shows them their blood sugar levels constantly. They'll also get regular support and advice to help them use this information to manage their diabetes. The other group will use a similar monitor, but they won't see their blood sugar levels themselves – the information will only be checked by the study team. This helps the researchers compare the effects of having real-time blood sugar information versus just having the data collected without immediate feedback.

Key takeaways

The study explores if continuous glucose monitors help people with type 2 diabetes after a heart attack.
It aims to see if better blood sugar control improves health and reduces heart problems.
Participants will either see their blood sugar constantly or have their data collected privately.
The study lasts for 26 weeks (about 6 months).
It's open to adults over 18 with type 2 diabetes who've had a recent heart attack.

Who may be eligible?

To join this study, you need to be an adult over 18 years old. You must have type 2 diabetes, which can be a condition you've had for a while or one you've been newly diagnosed with. You should also be taking medication for your diabetes, such as pills or insulin, and have recently had a heart attack.

There are some reasons why you might not be able to join. For instance, if your long-term blood sugar levels (HbA1c) are already very low, or if you've had certain surgeries like weight-loss surgery. People who are taking particular medications (like hydroxyurea) or who are on dialysis, are pregnant, or have a severe illness that limits their life expectancy to less than a year, would also not be able to take part. The study team will make the final decision based on your health situation.

There's also a part of the study for people with type 2 diabetes who had a heart attack some time ago (between 6 months and 10 years ago), and who are currently attending diabetes and heart clinics. The same exclusion criteria apply for this group.

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?
Do you have type 2 diabetes?
Have you recently had a heart attack (or between 6 months and 10 years ago)?
Are you taking medication for your diabetes (pills or insulin)?
Are you currently pregnant or on dialysis?
Have you had weight-loss surgery or a very short life expectancy?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be part of it for about 26 weeks (roughly 6 months). You'll be randomly assigned to one of two groups. If you're in the first group, you'll wear a Dexcom ONE continuous glucose monitor on your body for the entire 26 weeks. This device will show you your blood sugar levels in real-time. You'll also have meetings (in-person, over the phone, or video call) at 4 and 12 weeks with a healthcare professional who will review your blood sugar data and help adjust your diabetes treatment to keep your blood sugar in a healthy range.

If you're in the second group, you'll wear a continuous glucose monitor for several shorter periods (10 days each time) over the 26 weeks. However, this monitor won't show you your blood sugar levels; the information will be 'blinded' and only downloaded by the study team after each wear. You'll have study visits after each sensor wear to download the data. For this group, you'll manage your diabetes as you normally would, without direct clinical advice from the study team based on the monitor data. Both groups will have their health information collected and assessed at the end of the 26 weeks.

Potential risks and benefits

Taking part in this study could potentially help you understand and manage your blood sugar levels better, especially if you are in the group that sees your blood sugar in real-time. This improved management might lead to better heart health outcomes. However, as with any medical device, there's always a small chance of minor skin irritation from wearing the sensor. For the group not seeing their results, there's no direct benefit from the monitor data during the study but your information will contribute to important research. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Hammersmith Hospital inpatient cardiology services
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a continuous glucose monitor?

It's a small device that sticks to your skin, often on your arm or tummy, to continuously measure and track your blood sugar levels throughout the day and night.

What is 'time in glycaemic range'?

This refers to the percentage of time your blood sugar levels stay within a healthy target range, which is usually between 3.9 and 10 mmol/L for most people.

What is a 'heart attack' in simple terms?

A heart attack happens when blood flow to a part of the heart is blocked, damaging heart muscle. The medical term used in the study is 'Acute Myocardial Infarction'.

Will I know which group I'm in?

Yes, you will be told if you are in the group that sees their blood sugar in real-time or the group where the blood sugar data is 'blinded' to you.

Who is paying for this study?

This study is funded by Dexcom, the company that makes the continuous glucose monitoring system being used in the research.

How to find out more

Monika Reddy, MBChB, PhD

m.reddy@imperial.ac.uk 020 3311 1062 Official trial record

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