300 Participants Needed

Cognitive Behavioral Therapy for Prediabetes

SM
CC
Overseen ByChris Catlin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

There is no specific safety data available for Cognitive Behavioral Therapy in the context of prediabetes, but it is generally considered safe for humans as it is a non-invasive, psychological treatment commonly used for various mental health conditions.12345

How is the treatment SHUTi (Somryst) for prediabetes different from other treatments?

SHUTi (Somryst) is unique because it uses cognitive behavioral therapy (CBT) to address prediabetes, focusing on changing thought patterns and behaviors, unlike traditional treatments that primarily involve lifestyle changes or medications like metformin.26789

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Prediabetes?

Evidence-based lifestyle intervention programs, which include educational components similar to patient education, have been shown to significantly reduce the risk of developing type 2 diabetes in individuals with prediabetes, especially when the programs last 12 months or longer.1011121314

Who Is on the Research Team?

EL

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

I have trouble sleeping.
Regular access to device with internet access
Adequate data at baseline
See 2 more

Exclusion Criteria

You have a body mass index (BMI) higher than 40.
I have sleep-related issues noted in my medical records.
I have diabetes or I'm taking/planning to take diabetes medication.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six sessions of a digital CBT-I program or access to a patient education website over 11 weeks

11 weeks
Sessions delivered digitally

Follow-up

Participants are monitored for changes in glucose levels and other health metrics

22 weeks
Assessments at 11 weeks and 33 weeks post-baseline

What Are the Treatments Tested in This Trial?

Interventions

  • Patient Education
  • SHUTi
Trial Overview The study examines if cognitive behavioral therapy for insomnia (CBT-I) delivered online can lower blood sugar levels in prediabetic individuals compared to standard patient education about health. Participants will be randomly assigned to one of the two interventions.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Digital cognitive behavioral therapy (dCBT-I)Experimental Treatment1 Intervention
Group II: Patient Education (PE)Active Control1 Intervention

SHUTi is already approved in United States for the following indications:

🇺🇸
Approved in United States as Somryst for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials
563
Recruited
27,400,000+

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

Collaborator

Trials
2,513
Recruited
4,366,000+

Published Research Related to This Trial

Evidence-based lifestyle intervention programs lasting 12 months or longer are significantly more effective in reducing risks associated with prediabetes and Type 2 diabetes mellitus (T2DM) in individuals aged 45 and older compared to shorter programs.
This review analyzed 13 studies from a pool of 2654 articles, highlighting the importance of intervention duration in developing effective educational initiatives for at-risk patients.
A comparative review of nutrition education intervention duration and impact on reduction of prediabetes or Type 2 diabetes mellitus among adults aged 45 years or older.Corgatelli, C., Dodge, E., Bernstein, J., et al.[2023]
Lifestyle modification interventions are the most effective approach for reversing prediabetes, with 18% more participants achieving normal glucose levels compared to control groups, based on a systematic review of 54 studies involving 26,460 adults.
Pharmacological treatments, such as glucagon-like peptide-1 receptor agonists and α-glucosidase inhibitors, also effectively reverse prediabetes, but with moderate evidence; for example, these medications had a risk difference of 47% and a number needed to treat of 2.
Interventions for Reversing Prediabetes: A Systematic Review and Meta-Analysis.Galaviz, KI., Weber, MB., Suvada, K., et al.[2023]
Prediabetes, characterized by specific blood glucose levels, poses significant risks for complications, yet it is often overlooked in both health promotion and disease management.
The proposed framework for managing prediabetes includes screening and evidence-based health coaching, which together can effectively delay or prevent the progression to diabetes.
A conceptual framework for targeting prediabetes with lifestyle, clinical, and behavioral management interventions.Biuso, TJ., Butterworth, S., Linden, A.[2007]

Citations

A comparative review of nutrition education intervention duration and impact on reduction of prediabetes or Type 2 diabetes mellitus among adults aged 45 years or older. [2023]
Interventions for Reversing Prediabetes: A Systematic Review and Meta-Analysis. [2023]
A conceptual framework for targeting prediabetes with lifestyle, clinical, and behavioral management interventions. [2007]
Prediabetes in a nursing facility patient with renal insufficiency. [2010]
Vascular complications in prediabetes and type 2 diabetes: a continuous process arising from a common pathology. [2022]
Patient Perceptions About Prediabetes and Preferences for Diabetes Prevention. [2018]
Treating prediabetes: why and how should we do it? [2019]
Sitagliptin lowers glucagon and improves glucose tolerance in prediabetic obese SHROB rats. [2018]
Role of voglibose in the treatment of prediabetes in Indian population: a cross-speciality survey. [2021]
Choice of early treatment regimen and impact on β-cell preservation in type 2 diabetes. [2018]
Management of prediabetes. [2022]
[Prediabetes: diagnosis, evaluation of chronic complications, and treatment]. [2019]
13.Czech Republicpubmed.ncbi.nlm.nih.gov
Prediabetes. [2022]
[Recent advances in pharmacological intervention for prediabetes]. [2018]
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