A Sleep Intervention in Type 1 Diabetes

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

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 Overview

• Status: Completed
• Conditions: Type1diabetes; Short Sleep Phenotype
• Intervention / Treatment: Behavioral: Sleep Opt-In; Behavioral: Healthy Living

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep-Opt-In; Sleep optimization intervention	Behavioral: Sleep Opt-In; 8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling
Active Comparator: Healthy Living; Health education	Behavioral: Healthy Living; 8-week intervention that includes weekly telephone counseling on healthy living.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Chicago
• Investigators: Principal Investigator: Pamela Martyn-Nemeth, PhD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2019
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): November 20, 2019

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: sleep; type 1 diabetes; glycemic control; diabetes distress
• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Sleep Wake Disorders
• Other Study ID Numbers: 2018-0762; P30DK092949 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No