Sleep, Glycemic Control, and Insulin Resistance in Adolescents With Type 1 Diabetes

NCT ID: NCT03832790

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-04

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type1diabetes Adolescent Behavior Sleep

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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adolescents with type 1 diabetes

Adolescents ages 14-19 with type 1 diabetes

observation

Intervention Type OTHER

observation

Interventions

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observation

observation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juvenile Diabetes Research Foundation

OTHER

Sponsor Role collaborator

Colorado Clinical &amp; Translational Sciences Institute

UNKNOWN

Sponsor Role collaborator

Ludeman Family Center for Women&#39;s Health Research

UNKNOWN

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado Anschutz Medical Campus/Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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19-0186

Identifier Type: -

Identifier Source: org_study_id

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