Exploring how sleep patterns affect diabetes management
Chronotype of Patients With Diabetes and Effect on Glycaemic Control: The CODEC Study
This study is trying to see how different sleep patterns affect diabetes management in people aged 18 to 75 who have been living with diabetes for over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3447 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 1 site (Leicester) |
| Trial ID | NCT02973412 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between chronotype, which refers to an individual's natural sleep-wake cycle, and glycaemic control in patients with Type 1 and Type 2 diabetes. It will assess how sleep patterns may influence cardiometabolic health and various lifestyle factors in individuals diagnosed with diabetes. The study will include participants aged 18 to 75 years who have been diagnosed with diabetes for over six months and are currently managing their condition with glucose-lowering therapy or lifestyle modifications. By understanding these associations, the study seeks to identify new approaches to enhance diabetes management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with Type 1 or established Type 2 diabetes who are managing their condition with therapy or lifestyle changes.
Not a fit: Patients with significant sleep disorders other than Obstructive Sleep Apnoea or those with terminal illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diabetes management strategies tailored to individual sleep patterns.
How similar studies have performed: While there has been growing interest in the impact of sleep on diabetes management, this specific approach exploring chronotype in relation to glycaemic control is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. T1DM or established T2DM (\>6months since diagnosis) 3. Male or Female 4. Aged 18-75 years inclusive 5. BMI less than or equal to 45kg/m² inclusive 6. No known sleep disorders except Obstructive Sleep Apnoea (OSA) 7. On any glucose-lowering therapy (T1DM or T2DM) or lifestyle modification for management of T2DM 8. Good command of the English language Exclusion Criteria: 1. Participant is unwilling or unable to give informed consent 2. Anyone without a good command of the English language 3. Anyone \<18 years of age and \>75 years of age 4. BMI greater than 45 kg/m² 5. A regular cannabis user i.e. weekly use 6. Have a terminal illness 7. A known sleep disorder that is not OSA 8. Regular use of the following medicines i.e. Weekly use: (Wakefulness promoting agents Modafinil, Amphetamine derivatives, Methylphenidate; Sedatives including benzodiazepines, Z-drugs (zopiclone, zolpidem \& zaleplon); Melatonin, including Circadin and melatonin analogues; Clonazepam and other drugs for nocturnal movement disorders).
Where this trial is running
Leicester
- Leicester Diabetes Centre, Leicester General Hospital — Leicester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Andrew Hall — Sleep Consultant
- Study coordinator: Sahar Khodabakhsh, PhD
- Email: sahar.khodabakhsh@uhl-tr.nhs.uk
- Phone: 0116258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.