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OpenTrials
Completed

NCT Number: NCT03832790

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

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.

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Key information

Conditions

Type1diabetes Adolescent Behavior Behavior Sleep

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Aurora, Colorado, 80045, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

observation

Primary outcomes

  1. HbA1c

    Time frame: at 60 days

    HbA1c

  2. glycemic variability

    Time frame: at 2 weeks

    CGM glucose SD

  3. insulin sensitivity from hyperinsulinemic euglycemic clamp

    Time frame: at study entry (baseline)

    Si

  4. BMI

    Time frame: at study entry (baseline)

    body mass index

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Colorado Clinical & Translational Sciences Institute
  • Juvenile Diabetes Research Foundation
  • Ludeman Family Center for Women&#39;s Health Research

Registry information

Acronym: SunDIAL

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2019
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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