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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Leicester

About this trial

The goal of this clinical feasibility trial is to learn whether the investigators can improve sleep and reduce sedentary behaviour in people living with Type 2 diabetes mellitus with sleep problems. The main questions it aims to answer are: • question 1, can objectively measured sleep and sedentary behaviour be improved in the participants and • question 2, what effect will this have on a number of physical and physiological markers. Participants in the intervention group will be asked to keep sleep diaries and attend regular meetings with a qualified coach who will use a specific talking therapy to try to improve sleep and with use behaviour change techniques to help them be less sedentary. Researchers will compare the control group to the intervention group to see if effects differ between groups.

Eligibility criteria

Qualifiers

Diagnosed with Diabetes Mellitus type 2 for longer than 3 months

Participant is willing and able to give informed consent to take part in the study.

Sleep disorder symptom checklist 25 (SDS-CL-25) of ≥5 on insomnia criteria.

Not at high risk of undiagnosed Obstructive Sleep Apnoea (OSA), scoring ≥5 on STOP BANG scale (snoring, tired, observed, pressure, body mass index, age, neck size, gender) diagnosed treated OSA is acceptable.

Disqualifiers

Individuals living with narcolepsy or diagnosed parasomnia

Individuals with type 1 diabetes or gestational diabetes

Recent cardiovascular event (within the last 6 months).

Currently on opioids

Trial design

Treatments tested in this trial

  • CBTi
  • Control - usual care
  • Sedentary behaviour reduction

Treatment groups

44 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Leicester

Lead sponsor

University Hospitals, Leicester

Collaborator