Improving sleep and reducing sedentary behavior in people with Type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the feasibility of improving sleep quality and reducing sedentary behavior in individuals diagnosed with Type 2 diabetes mellitus who experience sleep problems. Participants will be divided into an intervention group, which will receive cognitive behavioral therapy for insomnia (CBTi) and behavior change techniques, and a control group receiving usual care. The study will measure changes in objectively assessed sleep and sedentary behavior, as well as various physical and physiological markers, over the course of the intervention. Regular meetings with a qualified coach will support participants in achieving these goals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* Glycated haemoglobin (HbA1c) of 10% or less (86 mmol/mol) or less
* Male or Females.
* ≥ 18 ≤ 75 years of age.
* Able to walk without the use of an assistive device or requiring assistance from another person.
* Not undertaking more than 75 minutes a week of strenuous exercise or sport.
* Not taking opioids
* Be treatment stable for at least 3 months
* Accelerometer measurement of SE ≤ 85%
* An understanding that CBTi may exacerbate sleep deprivation in the short term which may impact on certain aspects of daily life.

Exclusion Criteria:

* 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
* Diagnosed with borderline personality disorder, psychosis, adult attention deficit hyperactivity disorder (ADHD) or schizophrenia (self-reported).
* Individuals living with epilepsy or seizures.
* Shift workers
* Female participant planning to become pregnant with the timeframe of the study or is currently pregnant.
* Terminal illness.

Where it's running

• Diabetes Research Centre University Hospitals Leicester
  Leicester, Leicestershire, United Kingdom Recruiting

Study contacts

• Principal investigator: Melanie Davies, PhD — Leicester Diabetes Centre
• Study coordinator: Alix HA Covenant, MSc
• Email: ahac1@leicester.ac.uk
• Phone: 01162588572

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.