At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- CBTi (behavioural), Control - usual care (other), Sedentary behaviour reduction (behavioural)
- How long the study runs
- Study runs about 22 months (dates as stated)
- About the drug or intervention
- CBTi — behavioural: A 12 week intervention using CBTi to improve sleep measured using objective and subjective measures. · Control - usual care — other: Participants will be given a leaflet summarising good sleep practice and the advantages of reducing sedentary behaviour. · Sedentary behaviour reduction — behavioural: Participants will be encouraged to increase activity and thus reduce sedentary time.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 44
- Started
- 2024-09-02
- Last checked
- 2025-03
Plain English Summary
What is this study?
- • Testing a new treatment for diabetes mellitus, type 2
- • NA - 44 participants
- • 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
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with diabetes mellitus, type 2
Where?
- • Leicester - Diabetes Research Centre University Hospitals Leicester
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓Diagnosed with Diabetes Mellitus type 2 for longer than 3 months
- ✓Participant is willing and able to give agreement to take part to take part in the study.
- ✓Sleep disorder symptom checklist 25 (SDS-CL-25) of ≥5 on insomnia criteria.
- ✓Glycated haemoglobin (HbA1c) of 10% or less (86 mmol/mol) or less
- ✓Male or Females.
Who cannot take part
- ✗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...
See the full criteria
Where Is This Study? (1 UK site)
Diabetes Research Centre University Hospitals Leicester
Leicester LE5 4PW, United Kingdom
How to Get in Touch
Alix HA Covenant, MSc
Sponsor contactCONTACT
Joe Henson, PhD
Sponsor contactCONTACT