Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05823142
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-04-04
Brief Title:
Self-Management in Young Adults With Type 1 Diabetes 2023
Sponsor:
Case Western Reserve University
Organization:
Case Western Reserve University
Study Overview
Official Title:
Self-Management in Young Adults With Type 1 Diabetes 2023 R01DK136604
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 70 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
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
Detailed Description:
Overview The investigators will conduct a powered randomized controlled trial RCT and recruit a contemporary cohort of 248 young adults with T1D and randomly assign them to one of two conditions CB-sleep or a time-balanced attention control enhanced usual care condition The study will evaluate the immediate and short-term effects of CB-sleep compared to enhanced usual care on actigraphy and self-report derived sleep health dimensions aim 1 glycemia and other diabetes self-management outcomes aim 2 and whether sleep health mediates associations between the CB-sleep and enhanced usual care conditions aim 3 All participants will complete a battery of validated questionnaires and objective measures of sleep and glycemia captured at baseline to post-intervention 3 months and at a 6- and 9-month follow-up
Study Design
A two-arm RCT will be used to evaluate the efficacy of CB-sleep compared to a time-balanced attention control condition enhanced usual care Data collection will include T0 baseline measures questionnaires and 14-days of sleepglucose monitoring T1 will include the allocation to the experimental or control condition T2 will include immediate post baseline measures at 3-months T3 will include repeating measures at 6-months and T4 will include repeating measures at 9-months
Study Design
A two-arm RCT will be used to evaluate the efficacy of CB-sleep compared to a time-balanced attention control condition enhanced usual care Data collection will include T0 baseline measures questionnaires and 14-days of sleepglucose monitoring T1 will include the allocation to the experimental or control condition T2 will include immediate post baseline measures at 3-months T3 will include repeating measures at 6-months and T4 will include repeating measures at 9-months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK136604 | NIH | None | httpsreporternihgovquickSearchR01DK136604 |