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

An Efficacy Study Exploring the Optimisation of Sleep and the Reduction of Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Insomnia; Sedentary Behavior
• Intervention / Treatment: Behavioral: CBTi; Behavioral: Sedentary behaviour reduction; Other: Control - usual care

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alix HA Covenant, MSc; Phone Number: 01162588572; Email: ahac1@leicester.ac.uk
• Study Contact Backup: Name: Joe Henson, PhD; Phone Number: 1162588572; Email: jjh18@leicester.ac.uk

Study Locations

• United Kingdom
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE5 4PW
      • Recruiting
      • Diabetes Research Centre University Hospitals Leicester
      • Contact: Alix HA Covenant, MSc; Email: ahac1@leicester.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBTi and Sedentary Behaviour support; Participants will be counselled in how to improve their sleep and decrease sedentary behaviour using CBTi and behaviour change techniques.	Behavioral: CBTi; A 12 week intervention using CBTi to improve sleep measured using objective and subjective measures. Participants will complete a number of questionnaires and tests at baseline and at completion to allow comparisons to be made.; Behavioral: Sedentary behaviour reduction; Participants will be encouraged to increase activity and thus reduce sedentary time. Investigators will use behaviour change techniques to aid in this goal. Participants will complete a number of questionnaires and tests at baseline and at completion to allow comparisons to be made.
Active Comparator: Control - usual care; Participants will be given a leaflet containing brief information on good sleep hygiene practice and the benefits of decreasing sedentary behaviour.	Other: Control - usual care; Participants will be given a leaflet summarising good sleep practice and the advantages of reducing sedentary behaviour. Participants will complete a number of questionnaires and tests at baseline and at completion to allow comparisons to be made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Efficiency (SE) measured using accelerometer data.	The primary outcome measure is change in objectively measured SE in the intervention arm compared to the control group.	Before and after the 12 week intervention/intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objectively measured sleep - sleep onset latency	Accelerometer data will be used to measure sleep onset latency in minutes.	Before and after the 12 week intervention/intervention period
Objectively measured sleep - wake after sleep onset	Accelerometer data will be used to measure wake after sleep onset in minutes.	Before and after the 12 week intervention/intervention period
Objectively measured sleep - total sleep time	Accelerometer data will be used to measure total sleep time in minutes.	Before and after the 12 week intervention/intervention period
Objectively measured sleep - sleep duration variability	Accelerometer data will be used to measure sleep duration variability in minutes.	Before and after the 12 week intervention/intervention period
Objectively measured sleep - sleep midpoint variability	Accelerometer data will be used to measure sleep midpoint variability in minutes.	Before and after the 12 week intervention/intervention period
Objectively measured sedentary behaviour	Accelerometer data will be used to measure total time spent in sedentary time in minutes.	Before and after the 12 week intervention/intervention period
Objectively measured physical activity	Accelerometer data will be used to measure total time spent in physical activity in minutes.	Before and after the 12 week intervention/intervention period
Subjectively measured sleep - insomnia	The Insomnia Severity index, will be used to measure the level of insomnia - it is a questionnaire and has a range of 0-28 with higher scores indicating more insomnia.	Before and after the 12 week intervention/intervention period
Subjectively measured sleep quality -	The Pittsburgh Sleep Quality Index will be used to measure subjective sleep quality, this is a questionnaire and has a range of 0-21 with higher scores indicating worse sleep quality.	Before and after the 12 week intervention/intervention period
Subjectively measured sleepiness	Epworth Sleepiness Scale is a questionnaire and has a range of 0-24 with higher scores indicating more sleepiness.	Before and after the 12 week intervention/intervention period
Measurement of fatigue	The Functional assessment of chronic illness therapy (FACIT) scale will be used to subjectively measure fatigue, the range is 0-52 with higher scores indicating less fatigue.	Before and after the 12 week intervention/intervention period
Blood pressure	Blood pressure (both diastolic and systolic) will be measured using an automatic electronic device and the units used will be millimetres of mercury.	Before and after the 12 week intervention/intervention period
Fasting blood glucose	Fasting measured via a venous sample and in millimoles per litre (Mmol/L)	Before and after the 12 week intervention/intervention period
Continuous blood glucose	Continuous blood glucose measured via a continuous glucose monitor and in Mmol/L (Mmol/L)	Before and after the 12 week intervention/intervention period
Insulin	Insulin will be measured via a venous sample and in micro units per millilitre.	Before and after the 12 week intervention/intervention period
Triglycerides	Triglycerides will be measured via a venous sample and in Mmol/L.	Before and after the 12 week intervention/intervention period
Cholesterol	Cholesterol, including Low density lipoprotein and high density lipoprotein and total cholesterol, will be measured via a venous sample and in Mmol/L	Before and after the 12 week intervention/intervention period
Physical function - the short physical performance battery	The short physical performance battery consists of 3 physical tests, with a total score range of 0-12 with higher scores indicating better physical function.	Before and after the 12 week intervention/intervention period
Physical function - the sit to stand-60	The sit to stand-60 is the number of times the participant can rise from sit to stand in one minute using a designated chair with no arms and without the use of the participants arms, and is reported as a number.	Before and after the 12 week intervention/intervention period
Physical and Cognitive function - The World Health Organisation Disability Assessment schedule (WHODAS)	WHODAS is a questionnaire used to assess both physical and cognitive function. Each question is scored 0-4, scores are then averaged for all the questions so the range is 0-4 and the higher the score the more difficulty the participant is experiencing in functioning.	Before and after the 12 week intervention/intervention period
Cognitive function - verbal fluency test	Cognitive function will be measured using the verbal fluency test, which is conducted over two 60s periods and is scored by the number of correct answers.	Before and after the 12 week intervention/intervention period
Quality of life- European Quality of Life 5 dimension (EQ-5D-5L)	EQ-5D-5L, the five questions are scored 1-5 and each represents a different aspect, it is presented as a five digit number representing each domain. The higher the numbers, the worse quality of life.	Before and after the 12 week intervention/intervention period
Weight	Weight in kilograms will be measured.	Before and after the 12 week intervention/intervention period
Height	Height in metres will be measured.	Before and after the 12 week intervention/intervention period
Body mass index (BMI)	BMI will be calculated using weight and height to produce BMI in kg/m^2	Before and after the 12 week intervention/intervention period
Body composition - via bioimpedance	Bioimpedance scales will be used to measure body composition including percentage fat, muscle mass and water	Before and after the 12 week intervention/intervention period
Depression - The Patient Health Questionnaire-9 (PHQ9)	PHQ9 will be used to measure depressive symptoms. The PHQ9 has a range of 0-27 with higher scores indicating more depressive symptoms/depression.	Before and after the 12 week intervention/intervention period
Anxiety - The General Anxiety Disorder Assessment-7 (GAD7)	GAD7 will be used to measure anxiety symptoms. It has a range of 0-21, with higher scores indicating more anxiety.	Before and after the 12 week intervention/intervention period
Food intake - food diaries	3 Day food diaries will be used to measure food intake.	Before and after the 12 week intervention/intervention period

Collaborators and Investigators

• Sponsor: University of Leicester
• Collaborators: University Hospitals, Leicester
• Investigators: Principal Investigator: Melanie Davies, PhD, Leicester Diabetes Centre

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Sleep; Insomnia; Diabetes Mellitus, Type 2; Behaviour change; Sedentary behaviour; Cognitive Behaviour Therapy insomnia (CBTi)
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Mental Disorders; Metabolic Diseases; Glucose Metabolism Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Diabetes Mellitus, Type 2; Diabetes Mellitus; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 0955; 334347 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data in anonymised form may be suitable for sharing at the end of the trial. Should there be concerns about protecting the identity of participants/commercialisation of outputs, access restrictions will need to be considered. If suitable, anonymised data may be added to UoL's Research Archive (https://figshare.le.ac.uk/) within 6 months of the trial end date. The repository is registered in OpenDOAR and preserves research outputs (minimum of 10 years).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No