Self-Management in Young Adults With Type 1 Diabetes 2023

Description

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.

Conditions

Type1diabetes

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Study Overview

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Study Details

Study overview

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.

Self-Management in Young Adults With Type 1 Diabetes 2023 (R01DK136604)

Self-Management in Young Adults With Type 1 Diabetes 2023

Condition
Type1diabetes
Intervention / Treatment

-

Contacts and Locations

Cleveland

University Hospitals of Cleveland Medical Center, Cleveland, Ohio, United States, 44106-4904

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. are between the ages of 18-31 years;
  • 2. have been diagnosed with T1D for at least 1 year (diagnosis confirmed with ICD 10 code + ≥ 2 of the following: \<10 years age at dx, positive autoantibodies \[GAD65, IA2, ICA, ZnT8\], \<30 kg/m2 BMI at dx, diabetes ketoacidosis any time, C-peptide \< 0.8 ng/mL + associated glucose \>80 mg/dL, family history of 1st degree relative);
  • 3. are not currently participating in intervention studies;
  • 4. read/speak English,
  • 5. have ≥ 1 poor sleep health dimensions (satisfaction: PROMIS \> 56; alertness: ESS \> 7.5; timing/regularity: \>1 hour variability in bed or waketimes; efficiency: \<85%; or duration: \< 7 hours).
  • 6. treated sleep apnea and willingness to continue treatment for intervention (\>80% adherence),
  • 7. not achieving glycemic targets (defined as A1C ≥ 7%, or CGM derived glucose management indicator ≥ 7% or ≤ 80% time in glucose range).
  • 1. those with major chronic complex medical conditions (heart failure, GFR \< 45 using creatinine, frequent visits for chronic management);
  • 2. severe psychiatric illness (e.g., bipolar, schizophrenia);
  • 3. current pregnancy;
  • 4. recent or planned night shift work or trans-meridian travel;
  • 5. Unable to complete protocol (e.g., bereavement, currently homeless) and
  • 6. known history of untreated sleep apnea (obstructive or central).

Ages Eligible for Study

18 Years to 31 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Case Western Reserve University,

Stephanie Griggs, PhD, PRINCIPAL_INVESTIGATOR, Case Western Reserve University

Study Record Dates

2028-07-31