NCT03617770

A Sleep Intervention in Type 1 Diabetes

Completed NA Results posted Last updated 6 March 2024

What this trial tests

NA trial testing Sleep Opt-In in Short Sleep Phenotype in 14 participants. Completed in 20 November 2019.

Timeline

9 January 2019

Primary endpoint
20 November 2019

20 November 2019

Quick facts

Lead sponsor	University of Illinois at Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	9 January 2019
Primary completion	20 November 2019
Estimated completion	20 November 2019
Sites	1 location across United States

Drugs / interventions tested

• Sleep Opt-In
• Healthy Living

Conditions studied

• Short Sleep Phenotype — all drugs for Short Sleep Phenotype →
• Type1diabetes — all drugs for Type1diabetes →

Sponsor

University of Illinois at Chicago

Who can join

Adults 18 to 65, any sex, with Short Sleep Phenotype or Type1diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sleep Duration Primary · Assessing change between two time points:Week 0 to week 8

change in minutes of sleep (actigraphy-derived)

Group	Value	95% CI
Sleep-Opt-In	385	± 40
Healthy Living	388	± 39

Sleep Regularity Primary · Assessing change between two time points: from week 0 to week 8

Change in sleep regularity (variability)

Group	Value	95% CI
Sleep-Opt-In	46	± 20
Healthy Living	56	± 8

HbA1c Secondary · Change between two time points, week 0 to week 8

HbA1c (A1C%)

Group	Value	95% CI
Sleep-Opt-In	6.48	± 0.74
Healthy Living	6.7	± 1.4

Glucose Variability Secondary · Assessing change between two time points: from week 0 to week 8

Change in glucose variability (CV%) (continuous glucose monitor derived)

Group	Value	95% CI
Sleep-Opt-In	34.4	± 4.6
Healthy Living	31.6	± 5.0

Diabetes Distress Secondary · Assessing change between two time points: from week 0 to week 8

Change in Diabetes Distress Scale score, 6-point, 17-item Likert scale. The 17 items are summed. The sum score is divided by 17 to provide a mean item score. Higher scores indicate greater distress. Score interpretation: \< 2.0 = little distress 2.0-2.9 = moderate distress 3.0 or greater = hah distress

Group	Value	95% CI
Sleep-Opt-In	1.2	± 0.23
Healthy Living	3.1	± 1.36

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.