NCT06471634

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
2mo left

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Sep 2024Jul 2026

First Submitted

Initial submission to the registry

June 10, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 2, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

June 10, 2024

Last Update Submit

March 24, 2025

Conditions

Diabetes Mellitus, Type 2InsomniaSedentary Behavior

Keywords

SleepInsomniaSedentary behaviourDiabetes Mellitus, Type 2Cognitive Behaviour Therapy insomnia (CBTi)Behaviour change

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (29)

  • Objectively measured sleep - sleep onset latency

    Before and after the 12 week intervention/intervention period

  • Objectively measured sleep - wake after sleep onset

    Before and after the 12 week intervention/intervention period

  • Objectively measured sleep - total sleep time

    Before and after the 12 week intervention/intervention period

  • Objectively measured sleep - sleep duration variability

    Before and after the 12 week intervention/intervention period

  • Objectively measured sleep - sleep midpoint variability

    Before and after the 12 week intervention/intervention period

  • +24 more secondary outcomes

Study Arms (2)

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.

Behavioral: CBTiBehavioral: 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.

Other: Control - usual care

Interventions

CBTiBEHAVIORAL

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.

CBTi and Sedentary Behaviour support
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.

Control - usual care
Sedentary behaviour reductionBEHAVIORAL

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.

CBTi and Sedentary Behaviour support

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Research Centre University Hospitals Leicester

Leicester, Leicestershire, LE5 4PW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Sleep Initiation and Maintenance DisordersSedentary Behavior

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavior

Study Officials

  • Melanie Davies, PhD

    Leicester Diabetes Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alix HA Covenant, MSc

CONTACT

01162588572ahac1@leicester.ac.uk

Joe Henson, PhD

CONTACT

1162588572jjh18@leicester.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The technicians analysing the accelerometer data and blood analysis will be blinded as to which arm the participant is from, no other masking is possible.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2024

First Posted

June 24, 2024

Study Start

September 2, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations

GB(1)