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Health Behavior Intervention for Adults With Type 1 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 40 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Data collection will include T0 baseline measures (questionnaires and 14-days of sleep/glucose 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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (1)

GA