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Clinical Trials/NCT03832790
NCT03832790
Completed
Not Applicable

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

University of Colorado, Denver1 site in 1 country23 target enrollmentDecember 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type1diabetes
Sponsor
University of Colorado, Denver
Enrollment
23
Locations
1
Primary Endpoint
HbA1c
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 4, 2019
End Date
June 30, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

HbA1c

Time Frame: at 60 days

HbA1c

glycemic variability

Time Frame: at 2 weeks

CGM glucose SD

BMI

Time Frame: at study entry (baseline)

body mass index

insulin sensitivity from hyperinsulinemic euglycemic clamp

Time Frame: at study entry (baseline)

Si

Study Sites (1)

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