Diabetes Mellitus, Type 2NCT06471634
A Study Looking to Improve Sleep and Reduce Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus
A study testing CBTi and Sedentary behaviour reduction in people with Diabetes Mellitus, Type 2 and Insomnia, run by University of Leicester at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insomnia, Sedentary Behavior
- What is being tested?
- CBTi and Sedentary behaviour reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Sep 2024to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- ≥ 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.
Who cannot join
- 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.
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- Shift workers
- Female participant planning to become pregnant with the timeframe of the study or is currently pregnant.
- Terminal illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Diabetes Research Centre University Hospitals Leicester
Leicester, Leicestershire, LE5 4PW
Alix HA Covenant, MSc, ahac1@leicester.ac.uk
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Type 2, Insomnia, Sedentary Behavior
- Being tested
- CBTi, Control - usual care, Sedentary behaviour reduction
- Keywords
- Sleep, Insomnia, Sedentary behaviour, Diabetes Mellitus, Type 2, Cognitive Behaviour Therapy insomnia (CBTi), Behaviour change
- Medical subject headings
- Diabetes Mellitus, Type 2, Sleep Initiation and Maintenance Disorders, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTiBehavioural
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.
Control - usual careOther
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.
Sedentary behaviour reductionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBTi and Sedentary Behaviour support | Experimental | Participants will be counselled in how to improve their sleep and decrease sedentary behaviour using CBTi and behaviour change techniques. Receives: Behavioral: CBTi; Behavioral: Sedentary behaviour reduction |
| Control - usual care | Active comparator | Participants will be given a leaflet containing brief information on good sleep hygiene practice and the benefits of decreasing sedentary behaviour. Receives: Other: Control - usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after the 12 week intervention/intervention period
Secondary outcomes (29)
Objectively measured sleep - sleep onset latency
Accelerometer data will be used to measure sleep onset latency in minutes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: Before and after the 12 week intervention/intervention period
Insulin
Insulin will be measured via a venous sample and in micro units per millilitre.
Measured: Before and after the 12 week intervention/intervention period
Triglycerides
Triglycerides will be measured via a venous sample and in Mmol/L.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and after the 12 week intervention/intervention period
Weight
Weight in kilograms will be measured.
Measured: Before and after the 12 week intervention/intervention period
Height
Height in metres will be measured.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Before and after the 12 week intervention/intervention period
Food intake - food diaries
3 Day food diaries will be used to measure food intake.
Measured: Before and after the 12 week intervention/intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start2 Sep 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
- Investigators
- Melanie Davies, PhD, Principal investigator, Leicester Diabetes Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471634
- Sponsor's protocol ID
- 0955
- Other IDs
- 334347
- Status last verified
- Mar 2025
- First submitted
- 10 Jun 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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).
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy Study Exploring the Optimisation of Sleep and the Reduction of Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06471634
- Acronym / sponsor ID
- 0955
- Conditions
- Diabetes Mellitus, Type 2, Insomnia, Sedentary Behavior
- Keywords
- Sleep, Insomnia, Sedentary behaviour, Diabetes Mellitus, Type 2, Cognitive Behaviour Therapy insomnia (CBTi), Behaviour change
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBTi and Sedentary Behaviour support | Experimental | Behavioral: CBTi, Behavioral: Sedentary behaviour reductionParticipants will be counselled in how to improve their sleep and decrease sedentary behaviour using CBTi and behaviour change techniques. |
| Control - usual care | Active comparator | Other: Control - usual careParticipants will be given a leaflet containing brief information on good sleep hygiene practice and the benefits of decreasing sedentary behaviour. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBTiA 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. | Behavioural | CBTi and Sedentary Behaviour support |
| Control - usual careParticipants 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. | Other | Control - usual care |
| Sedentary behaviour reductionParticipants 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. | Behavioural | CBTi and Sedentary Behaviour support |
Primary outcome
Sleep Efficiency (SE) measured using accelerometer data.
Time frame: Before and after the 12 week intervention/intervention period
The primary outcome measure is change in objectively measured SE in the intervention arm compared to the control group.
29 secondary outcomes
Objectively measured sleep - sleep onset latency
Time frame: Before and after the 12 week intervention/intervention period
Objectively measured sleep - wake after sleep onset
Time frame: Before and after the 12 week intervention/intervention period
Objectively measured sleep - total sleep time
Time frame: Before and after the 12 week intervention/intervention period
Objectively measured sleep - sleep duration variability
Time frame: Before and after the 12 week intervention/intervention period
Objectively measured sleep - sleep midpoint variability
Time frame: Before and after the 12 week intervention/intervention period
Objectively measured sedentary behaviour
Time frame: Before and after the 12 week intervention/intervention period
Objectively measured physical activity
Time frame: Before and after the 12 week intervention/intervention period
Subjectively measured sleep - insomnia
Time frame: Before and after the 12 week intervention/intervention period
Subjectively measured sleep quality -
Time frame: Before and after the 12 week intervention/intervention period
Subjectively measured sleepiness
Time frame: Before and after the 12 week intervention/intervention period
Measurement of fatigue
Time frame: Before and after the 12 week intervention/intervention period
Blood pressure
Time frame: Before and after the 12 week intervention/intervention period
Fasting blood glucose
Time frame: Before and after the 12 week intervention/intervention period
Continuous blood glucose
Time frame: Before and after the 12 week intervention/intervention period
Insulin
Time frame: Before and after the 12 week intervention/intervention period
Triglycerides
Time frame: Before and after the 12 week intervention/intervention period
Cholesterol
Time frame: Before and after the 12 week intervention/intervention period
Physical function - the short physical performance battery
Time frame: Before and after the 12 week intervention/intervention period
Physical function - the sit to stand-60
Time frame: Before and after the 12 week intervention/intervention period
Physical and Cognitive function - The World Health Organisation Disability Assessment schedule (WHODAS)
Time frame: Before and after the 12 week intervention/intervention period
Cognitive function - verbal fluency test
Time frame: Before and after the 12 week intervention/intervention period
Quality of life- European Quality of Life 5 dimension (EQ-5D-5L)
Time frame: Before and after the 12 week intervention/intervention period
Weight
Time frame: Before and after the 12 week intervention/intervention period
Height
Time frame: Before and after the 12 week intervention/intervention period
Body mass index (BMI)
Time frame: Before and after the 12 week intervention/intervention period
Body composition - via bioimpedance
Time frame: Before and after the 12 week intervention/intervention period
Depression - The Patient Health Questionnaire-9 (PHQ9)
Time frame: Before and after the 12 week intervention/intervention period
Anxiety - The General Anxiety Disorder Assessment-7 (GAD7)
Time frame: Before and after the 12 week intervention/intervention period
Food intake - food diaries
Time frame: Before and after the 12 week intervention/intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: Undecided. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melanie Davies, PhD principal investigator
Leicester Diabetes Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBTi and Sedentary behaviour reduction in people with Diabetes Mellitus, Type 2 and Insomnia, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alix HA Covenant, MSc (01162588572, ahac1@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (SE) measured using accelerometer data. (time frame: Before and after the 12 week intervention/intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.