A Sleep Intervention in Type 1 Diabetes

Not Applicable

Completed

Conditions: Short Sleep Phenotype
Type1diabetes

Interventions: Behavioral: Sleep Opt-In
Behavioral: Healthy Living

Registration Number: NCT03617770

Lead Sponsor: University of Illinois at Chicago

Brief 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.

Detailed Description: Insufficient sleep and sleep irregularity (variability in sleep duration) are increasingly recognized as important contributors to glycemic control and diabetes distress in type 1 diabetes (T1D). Up to 40% of adults with T1D had a sleep duration \< 6-6.5 hours per night, either by self-report or objectively assessed actigraphy. Diabetes distress is reported (40% prevalence) in individuals with T1D and is associated with poor glycemic control. Despite findings that sleep disturbances are common in T1D, the current understanding of the effects of sleep optimization on sleep, diabetes distress, and glycemic control is limited. The purpose of this pilot and feasibility trial is to evaluate the effects of a T1D-specific sleep optimization intervention (Sleep-Opt-In) on the outcomes of sleep, diabetes distress and glycemic control in individuals with T1D and habitual short sleep. The specific aims are to determine if Sleep-Opt-In will: 1) be feasible and acceptable to the target population; 2) result in improved sleep duration and regularity; 3) result in improved glycemic control; and 4) lower diabetes distress. To achieve these aims, a randomized controlled trial in 20 adults aged 18 to 65 years with T1D is proposed. Participants will be screened for habitual sleep duration \< 6.5 hours per night. Eligible subjects will be randomized to the T1D-Sleep-Opt-In group or attention control group. A one-week run-in period is planned, with baseline measures of sleep (duration and regularity), glycemia (A1C, fructosamine, glycemic variability), and diabetes distress (Diabetes Distress Scale). The T1D-Sleep-Opt-In will entail a novel technology-assisted behavioral sleep extension intervention developed to leverage rapidly increasing public interest in sleep tracking by consumers (+500% in 3 years). This technology employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone application, and brief telephone counseling. The intervention will be T1D-specific by addressing T1D-related sleep issues such as nocturnal hypoglycemia. The attention control group will participate in a healthy living information program. At completion (Week 8) and post-program (Weeks 12 and 24), baseline measures will be repeated to determine differences between the two groups and sustainability of the intervention. Findings from this proposed pilot study will serve as the foundation for a larger clinical trial to improve sleep, reduce diabetes distress, and improve glycemic control.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 14

Inclusion Criteria

type 1 diabetes for one year or more
self-reported habitual sleep duration less than 6.5 hours per night during work- or weekdays
own a smartphone.

Exclusion Criteria

insomnia
sleep apnea
severe hypoglycemia within past 6 months
treated with an insulin pump with hybrid closed-loop features
rotating shift or night shift work
estimated glomerular filtration rate less than 45 ml/min
heart failure
cirrhosis
chronic obstructive pulmonary disease requiring oxygen
actively treated for cancer or psychiatric problem
history of stroke
pregnant or planning pregnancy
HbA1c 10% or higher.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep-Opt-In	Sleep Opt-In	Sleep optimization intervention
Healthy Living	Healthy Living	Health education

Primary Outcome Measures

Name	Time	Method
Sleep Regularity	Assessing change between two time points: from week 0 to week 8	Change in sleep regularity (variability)
Sleep Duration	Assessing change between two time points:Week 0 to week 8	change in minutes of sleep (actigraphy-derived)

Secondary Outcome Measures

Name	Time	Method
Diabetes Distress	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
HbA1c	Change between two time points, week 0 to week 8	HbA1c (A1C%)
Glucose Variability	Assessing change between two time points: from week 0 to week 8	Change in glucose variability (CV%) (continuous glucose monitor derived)