Type 1 Diabetes Clinical Trial
— SOPTOfficial title:
Sleep Optimization to Improve Glycemic Control in Adults With Type 1 Diabetes
Up to 40% of adults with type 1 diabetes have insufficient sleep which is associated with negative health consequences including poor blood glucose control and greater diabetes complications. In this study, a sleep intervention (Sleep-Opt) that uses wearable sleep tracking technology, telephone coaching and informational content designed to improve sleep and glycemic control in working-age adults with type 1 diabetes. Sleep-Opt could lead to reduced development of diabetes complications and improve quality of life for adults with type 1 diabetes.
Status | Recruiting |
Enrollment | 144 |
Est. completion date | April 30, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sleep variability | Standard deviation total sleep time for one week | Change from week 0, 6, 12, 24 | |
Primary | Sleep duration | total sleep time | Change from weeks 0. 6, 12, 24 | |
Primary | Glycemic control | HbA1c blood test | Change from week 0. 6, 12, 24 | |
Secondary | Diabetes distress | T1D Diabetes Distress Scale score- higher numbers indicate greater distress | Change from week 0. 6, 12, 24 | |
Secondary | Self-management behavior | Self-Management Questionnaire score- higher numbers indicate better self-management | Change from week. 6, 12, 24 | |
Secondary | Fatigue | Patient Reported Outcomes Measure (PROMIS) fatigue scale score - higher numbers greater fatigue | Change from week 0. 6, 12, 24 | |
Secondary | Mood | Center for Epidemiological Studies - Depressed Mood score - Higher numbers more depressive mood | Change from week 0. 6, 12, 24 |
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