Type 2 Diabetes Trial, Recruiting NCT06471634 Sponsor: University of Leicester Condition: Type 2 Diabetes
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Type 2 Diabetes Trial, Recruiting

NCT06471634
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with type 2 diabetes for more than 3 months
  • People who are willing and able to give their informed consent to take part in the study
  • People who score 5 or higher on a sleep disorder symptom checklist related to insomnia (the SDS-CL-25)
  • People who are not considered high risk for undiagnosed sleep apnoea, based on a screening tool called STOP BANG — people with already-diagnosed and treated sleep apnoea may still be eligible (confirm with trial site)
  • People whose blood sugar control measure (HbA1c) is 10% or less
  • People of any gender
  • People aged 18 to 75 years old
  • People who are able to walk on their own without a walking aid or help from another person
  • People who are doing less than 75 minutes of strenuous exercise or sport per week
  • People who are not currently taking opioid medications
  • People whose current treatments have been stable for at least 3 months
  • People whose sleep efficiency, measured by a wrist activity monitor, is 85% or below
  • People who understand that the sleep therapy used in this trial (CBTi) may temporarily make sleep worse and could affect daily life in the short term

Who may not be able to join:

  • People who have narcolepsy or a diagnosed sleep behaviour disorder (parasomnia)
  • People who have type 1 diabetes or gestational diabetes
  • People who have had a cardiovascular event (such as a heart attack or stroke) within the last 6 months
  • People who are currently taking opioid medications
  • People who have been diagnosed with borderline personality disorder, psychosis, adult ADHD, or schizophrenia (as reported by the individual)
  • People who have epilepsy or experience seizures
  • People who work shift work
  • People who are currently pregnant or planning to become pregnant during the study period
  • People who have a terminal illness

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Melanie Davies, PhD, Leicester Diabetes Centre

Phone: 01162588572

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
University of Leicester
Registry
ClinicalTrials.gov
Start date
2 September 2024
Est. completion
1 July 2026

Where this trial is recruiting

🇬🇧 United Kingdom

Primary endpoints

Sleep Efficiency (SE) measured using accelerometer data.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov