Sleep, Glycemic Control, and Insulin Resistance in Adolescents With Type 1 Diabetes
SunDIAL
1 other identifier
observational
23
1 country
1
Brief Summary
Despite advancements in care, most adolescents with T1D have higher BMI and significantly higher HbA1c than recommended and are markedly IR, placing them at increased risk for CVD1,2. Thus, alternative approaches to improve and maintain glycemic control, IR, and BMI for adolescents with T1D are urgently needed. This proposal moves beyond the current insulin and carbohydrate counting-focused lifestyle change paradigm to focus on sleep and circadian misalignment, which will allow for identification of new mechanisms that can be directly translated into future intervention and prevention trials. The goal of the current study is to utilize multiple objective measures of sleep duration, timing (actigraphy), and circadian rhythm (melatonin) in adolescents with type 1 diabetes (T1D; N = 40) and examine relationships with glycemic control, IR, vascular health, and BMI. Further, qualitative methodology will be used to identify barriers and facilitators to healthy sleep in adolescents with T1D.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2019
CompletedFirst Posted
Study publicly available on registry
February 6, 2019
CompletedStudy Start
First participant enrolled
December 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedOctober 1, 2024
September 1, 2024
3.5 years
February 4, 2019
September 27, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
HbA1c
HbA1c
at 60 days
glycemic variability
CGM glucose SD
at 2 weeks
insulin sensitivity from hyperinsulinemic euglycemic clamp
Si
at study entry (baseline)
BMI
body mass index
at study entry (baseline)
Study Arms (1)
adolescents with type 1 diabetes
Adolescents ages 14-19 with type 1 diabetes
Interventions
Eligibility Criteria
Adolescents with type 1 diabetes
You may qualify if:
- attending high school
- diagnosis of type 1 diabetes \>1 year
You may not qualify if:
- current diagnosis of a sleep disorder (e.g., insomnia, OSA) or abnormal scores on sleep disorders screening measures
- regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin, other sleep aids)
- HbA1c ≥11 or \>14% for the previous 2+ measurements
- IQ\<70 or severe mental illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Anschutz Medical Campus/Children's Hospital Colorado
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2019
First Posted
February 6, 2019
Study Start
December 4, 2019
Primary Completion
May 31, 2023
Study Completion
June 30, 2023
Last Updated
October 1, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share