CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
Sleep Opt-In +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03617770
NCT03617770N/ACompleted

A Sleep Intervention to Improve Glycemic Control and Reduce Diabetes Distress in Working Adults With Type 1 Diabetes

University of Illinois at Chicago·interventional·Posted Aug 6, 2018·Updated Mar 6, 2024

In Brief

A clinical study evaluating Sleep Opt-In and Healthy Living for Short Sleep Phenotype and Type1diabetes. Completed, enrolled 14 participants across 1 site.

Detailed Summary

Insufficient sleep and sleep irregularity (variability in sleep duration) are increasingly recognized as important contributors to glucose control and diabetes distress in type 1 diabetes (T1D). Up to 40% of adults with T1D had a sleep duration less than 6-6.5 hours per night. Diabetes distress is reported (40% prevalence) in individuals with T1D and is associated with poor glucose control. Despite findings that sleep disturbances are common in T1D, the current understanding of the effects of strategies to improve sleep on diabetes distress, and glucose control is limited. The purpose of this pilot study is to evaluate the effects of a sleep intervention on sleep duration, diabetes distress and glucose control in individuals with T1D and habitual short sleep. A randomized controlled trial in 20 adults aged 18 to 65 years with T1D is proposed. Eligible participants will be randomly assigned to a sleep intervention group or a control group. Differences between the two groups on the outcomes of sleep duration, diabetes distress and glucose control will be evaluated. Findings from this proposed pilot study will serve as the foundation for a larger clinical trial to improve sleep, reduce diabetes distress, and improve glucose control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 6, 2018
Enrollment StartJan 9, 2019
Primary CompletionNov 20, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.9 years ago

Interventions

Sleep Opt-Inbehavioral

8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling

Healthy Livingbehavioral

8-week intervention that includes weekly telephone counseling on healthy living.