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

Sleep Clinical Trial

— SunDIAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03832790
• Other study ID #: 19-0186
• Status: Completed
• Start date: December 4, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2023
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Insulin Resistance
• Sleep
• Type1diabetes

Intervention

Other:
• observation
observation

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus/Children's Hospital Colorado	Aurora	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	Colorado Clinical & Translational Sciences Institute, Juvenile Diabetes Research Foundation, Ludeman Family Center for Women's Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	HbA1c	at 60 days
Primary	glycemic variability	CGM glucose SD	at 2 weeks
Primary	insulin sensitivity from hyperinsulinemic euglycemic clamp	Si	at study entry (baseline)
Primary	BMI	body mass index	at study entry (baseline)