Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk

December 11, 2025 updated by: Kaiser Permanente

Sleep for Health: A Randomized Clinical Trial Examining the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk

This study tests whether providing cognitive behavioral therapy for insomnia (CBT-I) to people with prediabetes results in a reduction in glucose levels compared to a patient education control program.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Type 2 diabetes mellitus (T2D) is a major cause of blindness, kidney failure, cardiovascular disease, amputations, reduced quality of life, and premature death in the United States, and it is expected that one in three Americans will have T2D by 2050. To stem the tide of this health crisis, new strategies are needed to prevent the progression to T2D from prediabetes-elevated glucose levels that are not yet in the diabetes range. A growing body of research suggests that insomnia is a major modifiable risk factor for progression to diabetes. The proposed study would build off a promising feasibility study to test whether providing cognitive behavioral therapy for insomnia (CBT-I) to patients with prediabetes results in a reduction in glucose levels compared to a patient education control program. If so, this insomnia treatment could be an effective tool to prevent diabetes.

Individuals with prediabetes and insomnia will be randomized to receive six sessions of a deployment-ready digital CBT-I program, providing standard-of-care treatment for insomnia (intervention arm, n = 150), or a patient education website providing nontailored material about insomnia (control arm, n = 150). The investigators will complete assessments at baseline, at 11 weeks (after the conclusion of the intervention and control programs), and at 33 weeks post-baseline, measuring hyperglycemia, objective and subjective measures of sleep, and potential mediating variables including diet, exercise, and mood.

The investigators will assess (1) whether individuals randomized to the intervention arm have lower rates of hyperglycemia, as measured by oral glucose tolerance testing and various secondary measures, than individuals randomized to the control arm at 11 weeks and 33 weeks after baseline; (2) whether improvements in sleep after baseline are associated with decreases in hyperglycemia, regardless of study arm; and (3) whether any effects of the intervention on hyperglycemia are mediated by improvements in sleep, diet, exercise, and/or mood.

This research will serve as a critical step in identifying a potentially dramatic tool for improving health outcomes for Americans at risk of T2DM. Sleep interventions can lead to sustained improvements that are intrinsically rewarding to patients. If effective, digital CBT-I could provide a powerful pathway to preventing diabetes for millions of patients with prediabetes.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Kaiser Permanente Center for Health Research
        • Contact:
        • Contact:
        • Principal Investigator:
          • Erin LeBlanc, MD
        • Sub-Investigator:
          • Greg Clarke, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 22 years and < 80 years of age
  • Prediabetes
  • Insomnia
  • Regular access to device with internet access
  • Adequate data at baseline

Exclusion Criteria:

  • BMI > 40 kg/m2
  • Sleep comorbidities detected in medical record or via medical history
  • Shift work or significant, externally imposed irregular sleep schedule
  • moderate to severe OSA by home sleep apnea test as part of trial protocol
  • Received a full course of CBT-I in the last 12 months
  • Current use of medication with glycemic effects:
  • History of type 1 or type 2 diabetes or recent/planned use of hypoglycemic agents (e.g., metformin, insulin)
  • Recent history of bariatric surgery or planning bariatric surgery in the next year
  • Current or recent use of weight loss meds
  • Unstable sleep medication regimen (recent change to schedule or dosage)
  • Significant comorbidity that may interfere with CBT-I uptake or increase risks
  • Unwilling or unable to limit heavy machinery use/long bouts of driving or unstable illness that would be worsened by sleep restriction
  • High risk of falls
  • Epilepsy
  • Medical conditions that interfere with dCBT-I or contribute to insomnia or diabetes risk (e.g., hyperthyroidism, significant kidney disease, active cancer treatment, any medical condition that requires chronic steroid use)
  • Significant alcohol or substance use disorder
  • Active or recent history of eating disorder, recent weight change of >10%
  • Women: pregnancy (current or planned), breastfeeding, < 1 year postpartum
  • Use of hydroxyurea
  • Extensive skin changes or adhesive allergy making CGM sensor use problematic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital cognitive behavioral therapy (dCBT-I)
CBT-I is designed to change sleep habits and scheduling factors that affect sleep, and to address misconceptions about sleep and insomnia that perpetuate sleep difficulties. The investigators will employ SHUTi, which is an extensively studied dCBT-I program. SHUTi is intended to improve insomnia symptoms by providing neurobehavioral intervention (cognitive behavioral therapy for insomnia - CBT-I) in adults with chronic insomnia. It is a six-core internet-delivered CBT-I web-based app that is run through a browser. It is accessible via iPhone/iPad, Android phone/tablet, computer or laptop (any device with a browser). SHUTi follows evidence-based CBT-I principles.
Other: SHUTi
Each core includes a variety of interactive features, such as animations, vignettes, "myth" and "reality" buttons that reveal common misperceptions and facts about sleep, "learn more" buttons that provide in-depth information about a topic, and quizzes. All cores follow a similar structure with objectives, main content, homework, and review. Participants are free to revisit cores as many times as they like.
Active Comparator: Patient Education (PE)
Participants will be given access to a patient education website. It will provide nontailored material about insomnia symptoms; the impact, prevalence, and causes of insomnia; and basic lifestyle, environmental, and behavioral strategies to improve sleep.
Other: Patient Education
The PE website will present content in a simple, static form, without interactive components; and all content on the website will be provided at once, rather than in modules that unlock over time. The PE website will also not provide personalized or individually tailored treatment recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-hour post-load glucose (2hPG) (mg/dL)
Time Frame: V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)
2-hour post-load glucose (mg/dL)
V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c (A1C) (percentage)
Time Frame: V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)
Plasma HgB A1C (percentage)
V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)
Fasting plasma glucose (FPG) (mg/dL)
Time Frame: V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)
Fasting plasma glucose levels (mg/dL)
V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)
Mean glucose on CGM (mg/dL)
Time Frame: V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)
Average blood glucose levels throughout CGM wear duration (mg/dL)
V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)
Insulin resistance score (probability ranking, Calculated using the insulin and C-peptide concentrations converted to pmol/L)
Time Frame: V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)
Insulin resistance score - (probability ranking, Calculated using the insulin and C-peptide concentrations converted to pmol/L)
V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

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

Investigators

  • Principal Investigator: Erin LeBlanc, MD, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DK132229 (U.S. NIH Grant/Contract)
  • 1R01DK132229-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make individual participant data (IPD) available to other researchers after the end of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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