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Clinical Trials/NCT04506151
NCT04506151CompletedNot Applicable

Sleep Optimization to Improve Glycemic Control in Adults With Type 1 Diabetes

University of Illinois at Chicago2 sites in 1 country144 target enrollmentStarted: January 19, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
144
Locations
2
Primary Endpoint
Sleep variability

Study Overview

Brief Summary

Up to 40% of adults with type 1 diabetes have insufficient sleep which is associated with negative health consequences including poor blood glucose control and greater diabetes complications. In this study, a sleep intervention (Sleep-Opt) that uses wearable sleep tracking technology, telephone coaching and informational content designed to improve sleep and glycemic control in working-age adults with type 1 diabetes. Sleep-Opt could lead to reduced development of diabetes complications and improve quality of life for adults with type 1 diabetes.

Detailed Description

Despite improvements in treatment regimens and technology, less than 20% of adults with type 1 diabetes (T1D) achieve glycemic targets. Sleep is increasingly recognized as a potentially modifiable target for improving glycemic control. Diabetes distress, poor self-management behaviors, and reduced quality of life (QoL) have also been linked to sleep variability and insufficient sleep duration. The American Diabetes Association Standards of Medical Care in Diabetes incorporated sleep as an important component of the medical evaluation in persons with diabetes. However, no specific recommendation was given as to how to improve sleep. A significant gap of knowledge exists regarding the effects of sleep optimization on glycemic control in T1D. The purpose of this study is to determine the efficacy of a T1D-specific sleep optimization intervention (Sleep-Opt) on the primary outcomes of sleep variability, sleep duration and glycemic control (A1C); other glycemic parameters (glycemic variability, time in range), diabetes distress, self-management behavior, QoL, and other patient reported outcomes in working-age adults with T1D and habitual increased sleep variability or short sleep duration. To achieve these aims, a randomized controlled trial is planned in 120 working age adults (18 to 65 years) with T1D. Participants will be screened for habitual sleep variability (> 1 hour/week) or insufficient sleep duration (< 6.5 hours per night). Eligible subjects will be randomized to the Sleep-Opt group or healthy living attention control group for twelve weeks. A one-week run-in period is planned, with baseline measures of sleep by actigraphy (sleep variability and duration), glycemia (A1C and related glycemic measures: glycemic variability and time in range using continuous glucose monitoring), and other secondary outcomes: diabetes distress, self-management behaviors, quality of life and additional patient-reported outcomes. Sleep-Opt is a technology-assisted behavioral sleep intervention that this study team developed that leverages the rapidly increasing public interest in sleep tracking by consumers (+500% in 3 years). The behavioral intervention employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone application, and brief telephone counseling. The attention control group will participate in a healthy living information program. At midpoint (Week 6) completion (Week 12) and post-program (Week 24), baseline measures will be repeated to determine differences between the two groups and sustainability of the intervention.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • adults aged 18-65 years
  • clinical diagnosis of type 1 diabetes minimum of one year
  • reported habitual sleep variability (1 hour/week or more) or sleep duration less than 6.5 hrs/night during work- or weekdays (confirmed with actigraphy sleep watch)
  • a desire to improve sleep
  • own a smartphone

Exclusion Criteria

  • insomnia symptoms
  • at high risk for obstructive sleep apnea
  • severe hypoglycemia episode in the past 6 months (e.g. loss of consciousness)
  • A1C greater than 10%
  • rotating shift or night shift work
  • use of sleep medications/aids
  • renal impairment (estimated glomerular filtration rate < 45 ml/min)
  • significant current medical morbidities (such as heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer, depression, history of stroke with neurological deficits
  • breast feeding, pregnant, or planning pregnancy

Outcomes

Primary Outcomes

Sleep variability

Time Frame: Change from week 0, 6, 12, 24

Standard deviation total sleep time for one week

Sleep duration

Time Frame: Change from weeks 0. 6, 12, 24

total sleep time

Glycemic control

Time Frame: Change from week 0. 6, 12, 24

HbA1c blood test

Sleep Variability Week 6

Time Frame: Week 6

Standard deviation total sleep time for one week

Sleep Variability Week 12

Time Frame: Week 12

Standard deviation total sleep time for one week

Sleep Variability Week 24

Time Frame: Week 24

Standard deviation total sleep time for one week

Sleep Duration Week 6

Time Frame: Weeks 6

total sleep time minutes

Sleep Duration Week 12

Time Frame: Week 12

total sleep time in minutes

Sleep Duration Week 24

Time Frame: Week 24

total sleep time in minutes

HbA1C Week 6

Time Frame: Week 6

Hemoglobin A1C week 6, %

HbA1C Week 12

Time Frame: Week 12

HbA1c blood test

HbA1C Week 24

Time Frame: Week 24

HbA1c blood test

Secondary Outcomes

  • Self-management behavior(Change from week. 6, 12, 24)
  • Fatigue(Change from week 0. 6, 12, 24)
  • Mood(Change from week 0. 6, 12, 24)
  • Diabetes distress(Change from week 0. 6, 12, 24)
  • Diabetes Distress Week 6(Week 6)
  • Diabetes Distress Week 12(Week 12)
  • Glucose Time-in-range Week 12(Week 12)
  • Diabetes Distress Week 24(Week 24)
  • Self-management Behavior Week 6(Week 6)
  • Self Management Behavior Week 12(Week 12)
  • Self Management Behavior Week 24(Week 24)
  • Quality of Life Week 6(Week 6)
  • Quality of Life Week 12(Week 12)
  • Quality of Life Week 24(Week 24)
  • Fatigue Week 6(Week 6)
  • Fatigue Week 12(Week 12)
  • Fatigue Week 24(Week 24)
  • Mood Week 6(Week 6)
  • Mood Week 12(Week 12)
  • Mood Week 24(Week 24)
  • Subjective Sleep Quality Week 6(Week 6)
  • Subjective Sleep Quality Week 12(Week 12)
  • Subjective Sleep Quality Week 24(Week 24)
  • Glycemic Variability Week 6(Week 6)
  • Glycemic Variability Week 12(Week 12)
  • Glycemic Variability Week 24(Week 24)
  • Glucose Time-in-range Week 6(Week 6)
  • Glucose Time-in-range Week 24(Week 24)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pamela Martyn-Nemeth

Professor

University of Illinois at Chicago

Study Sites (2)

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