Recruiting

Cognitive Behavioral Therapy

Sponsor:

Kaiser Permanente

Code:

NCT06067139

Conditions

Diabetes Mellitus, Type 2

Prediabetic State

Sleep Initiation and Maintenance Disorders

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

SHUTi

Patient Education

Study Details

Brief summary:

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.

Conditions

Diabetes Mellitus, Type 2

Prediabetic State

Sleep Initiation and Maintenance Disorders

Study ID

NCT06067139

Start date

Aug 1, 2023

Status verified date

Dec, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Stefan Massimino, MS

971-232-9343stefan.massimino@kpchr.org

Chris Catlin

971-369-0655chris.l.catlin@kpchr.org

Locations

Kaiser Permanente Center for Health Research

Recruiting

Portland, Oregon, United States, 97227

Contacts

Stefan Massimino, MS

971-232-9343stefan.massimino@kpchr.org

Chris Catlin

971-369-0655chris.l.catlin@kpchr.org

Principal Investigator:

Erin LeBlanc, MD

More Information

Sponsor

Kaiser Permanente

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2025-12-15.