A Sleep Intervention in Type 1 Diabetes

NCT03617770 | Completed Results DMC

• 2 other identifiers: 2018-0762P30DK092949
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Short Sleep Phenotype; Type1diabetes

Keywords

type 1 diabetes; glycemic control; sleep; diabetes distress

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• HbA1c

  Change between two time points, week 0 to week 8

• Glucose Variability

  Assessing change between two time points: from week 0 to week 8

• Diabetes Distress

  Assessing change between two time points: from week 0 to week 8

Study Arms (2)

Sleep-Opt-In

EXPERIMENTAL

Sleep optimization intervention

Behavioral: Sleep Opt-In

Healthy Living

ACTIVE COMPARATOR

Health education

Behavioral: Healthy Living

Interventions

Sleep Opt-In BEHAVIORAL

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

Sleep-Opt-In

Healthy Living BEHAVIORAL

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

Healthy Living

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Chicago: collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Pamela Martyn-Nemeth
• Organization: University of Illinois at Chicago

pmartyn@uic.edu

3129967903

Study Officials

• Pamela Martyn-Nemeth, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Biobehavioral Health Science College of Nursing

Model Details: Sleep optimization intervention will be compared to a healthy living attention control

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 6, 2018
• Study Start: January 9, 2019
• Primary Completion: November 20, 2019
• Study Completion: November 20, 2019
• Last Updated: March 6, 2024
• Results First Posted: March 5, 2021

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)