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

Completed

• Conditions: Type1diabetes; Adolescent Behavior; Sleep
• Interventions: Other: observation

• Registration Number: NCT03832790
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-06
• Study Start: 2019-12-04
• Primary Completion: 2023-05-31
• Study Completion: 2023-06-30
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
adolescents with type 1 diabetes	observation	Adolescents ages 14-19 with type 1 diabetes

Primary Outcome Measures

Name	Time	Method
HbA1c	at 60 days	HbA1c
glycemic variability	at 2 weeks	CGM glucose SD
BMI	at study entry (baseline)	body mass index
insulin sensitivity from hyperinsulinemic euglycemic clamp	at study entry (baseline)	Si

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus/Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States