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

NCT04506151 | Active Not Recruiting DMC

• 2 other identifiers: 2020-03741R01DK121726
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (3)

• Sleep variability

  Standard deviation total sleep time for one week

  Change from week 0, 6, 12, 24

• Sleep duration

  total sleep time

  Change from weeks 0. 6, 12, 24

• Glycemic control

  HbA1c blood test

  Change from week 0. 6, 12, 24

Secondary Outcomes (4)

• Diabetes distress

  Change from week 0. 6, 12, 24

• 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

Study Arms (2)

Sleep-Opt

EXPERIMENTAL

12-week intervention that includes self-monitoring, goal setting, motivational enhancement.

Behavioral: Sleep-Opt

Healthy Living

ACTIVE COMPARATOR

12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.

Behavioral: Healthy Living

Interventions

Sleep-Opt BEHAVIORAL

12-week behavioral intervention

Sleep-Opt

Healthy Living BEHAVIORAL

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Martyn-Nemeth P, Duffecy J, Quinn L, Reutrakul S, Steffen AD, Burke L, Clark Withington MH, Irsheed GA, Perez R, Park M, Saleh A, Mihailescu D, Baron KG. Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial. Trials. 2022 Aug 19;23(1):686. doi: 10.1186/s13063-022-06565-6.

  PMID: 35986415 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pamela Martyn-Nemeth, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Sleep optimization intervention will be compared to an attention control group

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 10, 2020
• Study Start: January 19, 2021
• Primary Completion: December 21, 2024
• Study Completion: April 30, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)