A Sleep Intervention in Type 1 Diabetes

NCT ID: NCT03617770

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-09
• Study Completion Date: 2019-11-20

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.

Conditions

Short Sleep Phenotype; Type1diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sleep-Opt-In

Sleep optimization intervention

Group Type: EXPERIMENTAL

Sleep Opt-In

Intervention Type: BEHAVIORAL

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

Healthy Living

Health education

Group Type: ACTIVE_COMPARATOR

Healthy Living

Intervention Type: BEHAVIORAL

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

Interventions

Sleep Opt-In

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

Intervention Type: BEHAVIORAL

Healthy Living

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Pamela Martyn-Nemeth

Assistant Professor Biobehavioral Health Science College of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela Martyn-Nemeth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P30DK092949

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2018-0762

Identifier Type: -

Identifier Source: org_study_id