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:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT04506151
Eligibility Criteria:
Inclusion Criteria:
* adults aged 18-65 years
* clinical diagnosis of type 1 diabetes minimum of one year
* reported habitual sleep variability (1 hour/week or more) or sleep duration less than 6.5 hrs/night during work- or weekdays (confirmed with actigraphy sleep watch)
* a desire to improve sleep
* own a smartphone
Exclusion Criteria:
* insomnia symptoms
* at high risk for obstructive sleep apnea
* severe hypoglycemia episode in the past 6 months (e.g. loss of consciousness)
* A1C greater than 10%
* rotating shift or night shift work
* use of sleep medications/aids
* renal impairment (estimated glomerular filtration rate \< 45 ml/min)
* significant current medical morbidities (such as heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer, depression, history of stroke with neurological deficits
* breast feeding, pregnant, or planning pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04506151
Study Brief:
Protocol Section:
NCT04506151