NCT05823142 Health Behavior Intervention for Adults With Type 1 Diabetes
| NCT ID | NCT05823142 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Type1diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-12-20 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-12-20 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Type 1 diabetes (T1D) affects approximately 2 million Americans, and only 2 in 8 young adults ages 18-31 years achieve glycemic targets (glycated hemoglobin A1C \<7.0%). Achieving glycemic targets is associated with reduced risk of micro-and macrovascular complications. Sleep deprivation leads to impaired glucose tolerance and insulin sensitivity in adults without chronic conditions and with T1D. Promoting sleep in laboratory and natural environments contributes to improvements in insulin sensitivity, glucose levels, and distress symptoms in young adults without chronic conditions and more time in range in adolescents with T1D. Multiple dimensions of sleep health (alertness, timing, efficiency, and sleep duration) are associated with better achievement of glycemic targets in adults with T1D. Therefore, sleep health dimensions are appropriate therapeutic targets to improve glucoregulation and other diabetes self-management outcomes in this population. Our primary objective is to evaluate the immediate and short-term effects of a 12-week CB-sleep intervention compared to enhanced usual care (time balanced attention control) on actigraphy- and self-report derived sleep health dimensions and diabetes self-management outcomes (glycemia and distress symptoms) over 9-months (Stage II of the NIH Model for Behavior Change, ORBIT phase III). CB-sleep is guided by principles and practices from motivational interviewing and the Transtheoretical Model of Behavior Change with interactive stage-matched sessions.
Eligibility Criteria
Inclusion Criteria: * Aged 18 to 40 years * Type 1 Diabetes at least 1 year * One or more sleep health dimension out of range Exclusion Criteria: * Non-English speaking * A1C \< 7% or \>80% time in glucose range
Contact & Investigator
Stephanie Griggs, PhD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT05823142 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Type1diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05823142 currently recruiting?
Yes, NCT05823142 is actively recruiting participants. Contact the research team at Stephanie.griggs2@emory.edu for enrollment information.
Where is the NCT05823142 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT05823142 clinical trial?
NCT05823142 is sponsored by Emory University. The principal investigator is Stephanie Griggs, PhD at Emory University. The trial plans to enroll 300 participants.
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