Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT02973412
Eligibility 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02973412
Study Brief:
Protocol Section:
NCT02973412