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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03832790

Acronym

SunDIAL

Enrollment

Registered

2019-02-06

Start date

2019-12-04

Completion date

2023-06-30

Last updated

2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior, Sleep, Type1diabetes

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.

Interventions

OTHERobservation

observation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to 19 Years

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026