Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk
Sleep for Health: A Randomized Clinical Trial Examining the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk
This study is testing if a digital therapy for insomnia can help people with prediabetes lower their blood sugar levels and prevent type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 22 Years to 79 Years |
| Sex | All |
| Sponsor | Kaiser Permanente Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06067139 on ClinicalTrials.gov |
What this trial studies
This study investigates whether cognitive behavioral therapy for insomnia (CBT-I) can lower glucose levels in individuals with prediabetes compared to a standard patient education program. Participants aged 22 to 80 with prediabetes and insomnia will be randomly assigned to receive either six sessions of a digital CBT-I program or access to a patient education website. Assessments will be conducted at baseline, 11 weeks, and 33 weeks post-baseline to measure changes in hyperglycemia, sleep quality, and other related factors. The goal is to determine if treating insomnia can effectively prevent the progression to type 2 diabetes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 to 80 with prediabetes and insomnia who have regular internet access.
Not a fit: Patients with a BMI over 40, significant sleep disorders, or a history of diabetes will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel method to prevent the onset of type 2 diabetes in at-risk individuals.
How similar studies have performed: Previous studies have shown promising results in using CBT-I to improve health outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Portland, Oregon
- Kaiser Permanente Center for Health Research — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Erin LeBlanc, MD — Kaiser Permanente
- Study coordinator: Stefan Massimino, MS
- Email: stefan.massimino@kpchr.org
- Phone: 971-232-9343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.