Abbott research trial for people with Type 2 diabetes, FreeDM2 – call to take part!

Clinicians across the UK are asking for people to participate in a study to assess the impact of the FreeStyle Libre 3 continuous glucose monitoring on outcomes in adults with Type 2 diabetes on basal insulin. By Sue Marshall.

The full title of the FreeDM2 study is actually, ‘Real-Time Glucose Monitoring Using FreeStyle Libre 3 in Adults With Type 2 Diabetes On Basal Insulin Plus SGLT2 Inhibitor and/or GLP-1’. FreeDM2 is a bit less of a mouthful, and neatly reflects the ‘diabetes mellitus’ Type 2 nature of the research. I

The purpose of the FreeDM2 study is to determine whether continuous glucose monitoring using FreeStyle Libre 3 ((FSL3) will improve HbA1c—among other measurements—compared to using fingerprick blood tests. People in the study will be followed up for eight months.

The study is sponsored by Abbott Diabetes Care. Its joint chief investigators are leading diabetologists Dr Emma Wilmot, University of Nottingham and Dr Lala Leelarathna, Imperial College, London.

Dr Wilmot (pictured) explains, “People with Type 1 diabetes in the UK now have access to continuous glucose monitoring sensors on the NHS. This is thanks to decades of research which shows that this can improve both high and low glucose levels. As a result NICE now recommends continuous glucose monitoring for all those living with Type 1 diabetes. People with Type 2 diabetes generally do not have access to this technology. We need research to understand whether the benefits seen in those with Type 1 diabetes can also be demonstrated in those with Type 2 diabetes. This is the purpose of the FreeDM2 study.”

You are eligible if you are an adult with sub-optimally controlled Type 2 diabetes on basal insulin therapy, with an HbA1c between 7.5-11%. To apply, CLICK HERE.

The main point

Assessing any changes in HbA1c is the main point of the study, which is split into two phases each of four months duration. The first phase is participant-driven, while phase 2 is HCP/therapy-driven. Participants will be randomly allocated to either FreeStyle Libre 3 (FSL3) or to continue using their current blood testing device. However, at the end of the study, any of the participants who end up in the latter group will also be given a four-month supply of FSL3 with medical supervision as a way of saying thank you for taking part.

For anyone considering taking part, the study will be split up into four steps:

  1. Participant selection – participants will complete a series of questions with the researchers to establish medical history, and so on.
  2. Group allocation—Initially, all participants will get two FSL3 sensors that will last 14 days in the masked mode. After that, they will be randomly allocated to either continue to use the CGM system for the full eight months or continue with existing blood glucose monitoring with finger-pricks and a meter. There is twice the chance of getting CGM compared to continuing with usual care.
  3. There follows a period of monitoring, including ongoing medical reviews to support participants to improve glucose control. A discussion will establish if it’s best to have your study visits in the clinic, at home, or virtually.
  4. Optional study extension – after the study ends at eight months, those who were allocated to stay on with blood testing will get the option to have four month’s-worth of FSL3 sensors, complete with medical oversight.

Dr Leelarathna (pictured) adds, “Participants might end up being part of an important change in the way that Type 2 diabetes is monitored and treated going into the future, while at the same time potentially significantly improving their own control, health and quality of life. This is a wide-ranging study with many established centres* taking part, and a list of very experienced consultants involved. I think it’s going to be quite an exciting undertaking; I can’t wait to see the results.”

EDITORS COMMENT: In order to get approved, this study application had to use fairly dense clinical language, which I’ve summarised here. However, the link at the end shows it in its full glory. So, check that out if you are interested in the details. Personally, if I had Type 2 and was taking insulin, I’d jump at the chance to take part! – Sue Marshall

*Officially, it’s a ‘prospective multi-centre, open-label, two arm, parallel design, superiority, pragmatic, randomised controlled trial, over an 8-month period’ [I told you I had summarised this!].

To apply, CLICK HERE.

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