Improving Sleep and Reducing Sedentary Behavior in Diabetes
A Study Looking to Improve Sleep and Reduce Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus
Recruiting
N/AInterventional Study
Diabetes Mellitus, Type 2InsomniaSedentary Behavior
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
44 (estimated)
Sponsor
University of Leicester · Other
Who this trial is looking for
This trial is looking for people with type 2 diabetes who have trouble sleeping. Participants will keep sleep diaries and attend regular meetings with a coach to help improve their sleep and reduce time spent sitting.
Are You a Good Fit for This Trial?
Must not be takingOpioids
Rules you outType 1 diabetesGestational diabetesNarcolepsyParasomniaEpilepsySeizures
You may be able to join if
I have been diagnosed with type 2 diabetes for more than 3 months.
I can give my consent to take part in the study.
I have at least 5 insomnia symptoms.
I am not at high risk for obstructive sleep apnea.
My glycated hemoglobin (HbA1c) is 10% or less.
I am between 18 and 75 years old.
I can walk without assistance.
I do not exercise strenuously for more than 75 minutes a week.
You may not be able to join if
I have narcolepsy or diagnosed parasomnia.
I have type 1 diabetes or gestational diabetes.
I have had a cardiovascular event in the last 6 months.
I am currently using opioids.
I have a history of certain mental health disorders.
I have epilepsy or seizures.
I work shifts.
I am planning to become pregnant or am currently pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 o…
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 Locations
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Eligibility Criteria
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 Sl…
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.
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