Cognitive Behavioral Therapy for Prediabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that participants do not use medications with glycemic effects (those that affect blood sugar levels) or have an unstable sleep medication regimen. If you are on such medications, you may need to stop or adjust them to participate.
Is Cognitive Behavioral Therapy safe for humans?
How is the treatment SHUTi (Somryst) for prediabetes different from other treatments?
What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Prediabetes?
Who Is on the Research Team?
Erin LeBlanc, MD
Principal Investigator
Kaiser Permanente
Are You a Good Fit for This Trial?
This trial is for adults aged 22 to 79 with prediabetes and insomnia who have internet access. It's not for those with other sleep disorders, severe skin issues or allergies affecting sensor use, irregular sleep schedules due to shift work, risks from sleep restriction like heavy machinery operation, a BMI over 40, certain medication uses including recent CBT-I therapy or diabetes treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive six sessions of a digital CBT-I program or access to a patient education website over 11 weeks
Follow-up
Participants are monitored for changes in glucose levels and other health metrics
What Are the Treatments Tested in This Trial?
Interventions
- Patient Education
- SHUTi
SHUTi is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kaiser Permanente
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator