Active not recruitingNAINTERVENTIONAL

CGM Use in Adults With Type 2 Diabetes on Basal Insulin

This study is for adults with type 2 diabetes who use basal insulin and whose blood sugar isn't as controlled as it could be. Researchers want to find out if using a special device called a FreeStyle Libre 3 continuous glucose monitor (which checks blood sugar constantly) works better than traditional finger-prick tests. The main goal is to see if it helps lower a long-term blood sugar measure called HbA1c over 16 weeks. The study will last for 8 months in total, with an optional longer follow-up. Participants will be put into one of two groups: one using the FreeStyle Libre 3 and the other continuing with their usual finger-prick blood sugar checks.

At a glance

Status

Active not recruiting

Phase

Sponsor

Abbott Diabetes Care

Enrolment target

470

Start

14 Jul 2023

Estimated completion

30 Nov 2027

Diabetes Mellitus, Type 2

What is this study about?

This study is looking into how different ways of checking blood sugar can help people with type 2 diabetes. Specifically, it's comparing a device called the FreeStyle Libre 3, which is a continuous glucose monitor (CGM), with the usual method of checking blood sugar using finger-prick tests. The FreeStyle Libre 3 is a small sensor you wear that automatically reads your sugar levels all day and night. The researchers want to see if having these constant readings helps people with type 2 diabetes manage their condition better.

The main thing the study wants to measure is called HbA1c. This is a blood test that shows your average blood sugar levels over the past 2 to 3 months. If your HbA1c goes down, it means your blood sugar control has improved. Those taking part will be assigned by chance to either use the FreeStyle Libre 3 or stick with their current finger-prick checks. The study will last for 8 months, with the main comparison happening over the first 16 weeks.

After the initial 8 months, there's an option for some people to be followed for an even longer period – up to 2 years. This longer follow-up will help researchers understand how blood sugar control and treatments change over a longer time. The study is designed to be very practical, meaning it aims to see how these devices work in real-life situations for people with type 2 diabetes receiving certain diabetes medications.

Key takeaways

Compares continuous glucose monitoring (FreeStyle Libre 3) versus finger-prick tests for type 2 diabetes.
Aims to see if the continuous monitor improves long-term blood sugar levels (HbA1c).
For adults with type 2 diabetes using basal insulin whose HbA1c is 7.5-11%.
Study lasts 8 months, with an optional longer follow-up.
Participants will be randomly assigned to one of the two groups.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be part of this study, you need to be an adult aged 18 or older and have been diagnosed with type 2 diabetes for at least a year. You must also be currently using basal insulin injections (a type of long-acting insulin) and potentially other diabetes medicines like SGLT2 inhibitors or GLP-1s. Your recent HbA1c blood test, which shows your average blood sugar over the last few months, should be between 7.5% and 11.0% (this indicates your blood sugar isn't as controlled as doctors would ideally like).

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 2 diabetes for at least one year?
Do you take basal insulin injections for your diabetes (and possibly SGLT2 or GLP-1 medicines)?
Is your HbA1c (average blood sugar) between 7.5% and 11.0%?
Are you NOT currently using prandial or pre-mixed insulin?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve different stages over an 8-month period. You'll be randomly assigned to one of two groups: either using the FreeStyle Libre 3 continuous glucose monitor or continuing with your current method of checking blood sugar with finger-prick tests. You will have regular visits to the clinic for assessments and blood tests, including checks of your HbA1c. The study is split into two four-month parts.

After completing the main 8-month study, there's an optional extra part where researchers might continue to follow your blood sugar control and treatment for up to 24 months. You won't be given new medicines, but your progress will be monitored. You will be told what to expect regarding appointments and any devices you might use, and you'll receive support throughout the study.

Potential risks and benefits

Taking part in a study like this might offer some benefits, such as potentially improving your blood sugar control through closer monitoring or learning more about managing your diabetes. Being closely monitored by healthcare professionals could also be a benefit. However, there are also potential risks; for example, using a new device like the FreeStyle Libre 3 might involve minor skin irritation where the sensor is applied. There's always a chance that the new device might not lead to better blood sugar control for you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (25)

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

Tameside General Hospital
Verified postcode
Ashton-under-Lyne, United Kingdom
Royal United Hospital
Verified postcode
Bath, United Kingdom
Queen Elizabeth Hospital
Verified postcode
Birmingham, United Kingdom
Cambridge University Hospital (Addenbrookes)
Verified postcode
Cambridge, United Kingdom
Darlington Memorial Hospital
Verified postcode
Darlington, United Kingdom
Royal Derby Hospital
Verified postcode
Derby, United Kingdom
Ninewells Hospital
Verified postcode
Dundee, United Kingdom
Princess Alexandra Hospital
Verified postcode
Harlow, United Kingdom
Northwick Park Hospital
Verified postcode
Harrow, United Kingdom
Hull Royal Infirmary
Verified postcode
Hull, United Kingdom
Ipswich Hospital
Verified postcode
Ipswich, United Kingdom
St James University Hospital
Verified postcode
Leeds, United Kingdom

Common questions

What is HbA1c?

HbA1c is a blood test that shows your average blood sugar levels over the last 2 to 3 months. It's a key measurement for how well diabetes is being controlled.

What is a continuous glucose monitor (CGM)?

A continuous glucose monitor (CGM) is a small device you wear that automatically checks and records your blood sugar levels throughout the day and night without needing finger-pricks.

Will I get to choose which device I use?

No, participants will be randomly assigned to either use the FreeStyle Libre 3 or continue with their usual finger-prick blood sugar checks. This is a common way to make studies fair.

How long will I be in the study?

The main part of the study lasts for 8 months. After that, there's an optional follow-up period that could last up to 2 years.

What if I get pregnant during the study?

If you are pregnant, or become pregnant during the study, you would not be able to participate or continue. This is for your safety and the accuracy of the study results.