- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03832790
Sleep, Glycemic Control, and Insulin Resistance in Adolescents With Type 1 Diabetes (SunDIAL)
September 26, 2023 updated by: University of Colorado, Denver
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
23
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Anschutz Medical Campus/Children's Hospital Colorado
-
-
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.
Eligibility Criteria
Ages Eligible for Study
14 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Adolescents with type 1 diabetes
Description
Inclusion Criteria:
- attending high school
- diagnosis of type 1 diabetes >1 year
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
adolescents with type 1 diabetes
Adolescents ages 14-19 with type 1 diabetes
|
observation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: at 60 days
|
HbA1c
|
at 60 days
|
glycemic variability
Time Frame: at 2 weeks
|
CGM glucose SD
|
at 2 weeks
|
insulin sensitivity from hyperinsulinemic euglycemic clamp
Time Frame: at study entry (baseline)
|
Si
|
at study entry (baseline)
|
BMI
Time Frame: at study entry (baseline)
|
body mass index
|
at study entry (baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 4, 2019
Primary Completion (Actual)
May 31, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
February 4, 2019
First Submitted That Met QC Criteria
February 5, 2019
First Posted (Actual)
February 6, 2019
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 26, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-0186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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