RecruitingNAINTERVENTIONAL

A Study Looking to Improve Sleep and Reduce Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus

This study is for people with Type 2 diabetes who have trouble sleeping and spend a lot of time sitting down. Researchers want to see if a special talking therapy, along with tips to be more active, can help improve their sleep and reduce sedentary behaviour. The main goals are to find out if these changes can actually happen and what effect they might have on important health markers like blood sugar levels. Participants in one group will receive coaching on improving sleep and reducing inactivity, keeping sleep diaries, and having regular meetings. This will then be compared to a group receiving standard care to understand if the new approach is effective.

At a glance

Status

Recruiting

Phase

Sponsor

University of Leicester

Enrolment target

Start

02 Sep 2024

Estimated completion

01 Jul 2026

Diabetes Mellitus, Type 2 Insomnia Sedentary Behavior

What is this study about?

This research is a pilot study, which means it's a first step to see if a new approach could be helpful for people living with Type 2 diabetes. We know that many people with Type 2 diabetes also have trouble sleeping and might not be as active as they could be. This study aims to explore if a specific type of talking therapy for sleep problems, called CBTi (Cognitive Behavioural Therapy for Insomnia), combined with guidance on being more active, can make a real difference.

The main idea is to see if we can help people to sleep better and move more. Researchers will carefully check whether these changes genuinely happen and then look at what impact this has on other important health measures. For example, they'll see how these improvements might affect blood sugar levels, blood pressure, and general feelings of well-being.

By understanding this better, we hope to find new ways to support people with Type 2 diabetes to live healthier and more comfortable lives. The information gathered from this study could help shape future, larger studies and ultimately lead to better care for people with this condition.

Key takeaways

This study explores new ways to help people with Type 2 diabetes sleep better and be more active.
It uses a special talking therapy for sleep and advice on reducing inactive time.
Researchers will compare these new approaches to standard care.
The findings could lead to better support for managing Type 2 diabetes.
Participation involves meetings with a coach and tracking your progress.

Who may be eligible?

To join this study, you generally need to be between 18 and 75 years old and have been diagnosed with Type 2 diabetes for at least three months. It's also important that you're currently experiencing some sleep problems and can walk without help from others or walking aids. Your long-term blood sugar levels (measured by an HbA1c test) should be 10% or less.

There are also some things that would mean you couldn't join. For example, if you have Type 1 diabetes or gestational diabetes, or if you've recently had a serious heart problem within the last six months. People who work night shifts, are pregnant or planning to become pregnant, or have conditions like narcolepsy or certain mental health diagnoses such as psychosis would also not be able to take part. Similarly, if you are taking opioid medication or have certain other medical conditions, you might not be eligible.

Quick self-check

Do you have Type 2 diabetes and have had it for more than 3 months?
Do you often struggle with sleep problems?
Are you between 18 and 75 years old?
Is your walking generally unassisted?
Are you not currently taking strong pain medications (opioids)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll be part of a group that receives either the special support or standard care. Those in the support group will meet regularly with a trained coach. These meetings will involve a specific talking therapy to help with sleep and advice on how to be more active. You'll also be asked to keep a sleep diary to track your progress.

Throughout the study, researchers will use special devices to measure your sleep patterns and how active you are. They'll also check various health markers, likely through blood tests and other routine health checks. The total duration of your involvement in the study will be explained to you in detail before you decide to take part.

Potential risks and benefits

Taking part in research can offer potential benefits, such as receiving specialised support to improve your sleep and activity levels, which might positively impact your overall health. However, there can also be some risks; for instance, the sleep therapy might temporarily make your sleep worse before it gets better. All procedures are designed to be as safe as possible, and you will be fully informed about any potential discomforts. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time without giving a reason.

Locations (1)

Diabetes Research Centre University Hospitals Leicester
Leicester, United Kingdom· Recruiting

Common questions

What is CBTi?

CBTi stands for Cognitive Behavioural Therapy for Insomnia. It's a structured talking therapy that helps you identify and change thoughts and behaviours that are keeping you from sleeping well.

What does 'sedentary behaviour' mean?

Sedentary behaviour refers to activities where you are sitting or lying down for long periods and using very little energy, like watching TV or working at a desk.

Will I have to take new medication?

The study focuses on lifestyle changes and talking therapy, not on introducing new medications. Your current diabetes treatment should remain stable.

How long will the study last for me?

The specific duration of your participation will be fully explained by the research team if you are eligible and interested in joining.

Who will see my information?

Your personal and health information will be kept strictly confidential and only accessed by the research team, following strict data protection rules.

How to find out more

Alix HA Covenant, MSc

ahac1@leicester.ac.uk 01162588572 Official trial record

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