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

University of Leicester

Status: Enrolling

Conditions: Insomnia; Diabetes Mellitus, Type 2; Sedentary Behavior

Treatments: Behavioral: CBTi; Other: Control - usual care; Behavioral: Sedentary behaviour reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT06471634

334347 (Other Identifier)

0955

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

44 participants in 2 patient groups

CBTi and Sedentary Behaviour support

Experimental group

Description:

Participants will be counselled in how to improve their sleep and decrease sedentary behaviour using CBTi and behaviour change techniques.

Treatment:

Behavioral: Sedentary behaviour reduction

Behavioral: CBTi

Control - usual care

Active Comparator group

Description:

Participants will be given a leaflet containing brief information on good sleep hygiene practice and the benefits of decreasing sedentary behaviour.

Treatment:

Other: Control - usual care