Cognitive Behavioral Therapy for Prediabetes

Overseen By Chris Catlin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Must not be taking: Hypoglycemics, Weight loss meds

Disqualifiers: Diabetes, OSA, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 11 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a digital form of cognitive behavioral therapy for insomnia (CBT-I) can help lower blood sugar levels in people with prediabetes. Participants will either use a web-based CBT-I program called SHUTi, which provides strategies to improve sleep, or access a patient education website with general information about insomnia. It targets adults with prediabetes and chronic insomnia who have regular internet access. The trial aims to determine if better sleep can lead to improved blood sugar control. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance sleep and blood sugar management.

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.

What prior data suggests that this digital cognitive behavioral therapy is safe for people with prediabetes?

Research has shown that digital cognitive behavioral therapy for insomnia (dCBT-I), such as the SHUTi program, is generally safe. SHUTi, an online app, improves sleep by changing sleep habits and correcting misunderstandings about insomnia. It has undergone extensive study and is well-received. No specific safety issues have been identified for its use in individuals with prediabetes.

Cognitive behavioral therapy (CBT) is a common and trusted treatment for many conditions, with a strong safety record. Although specific safety data for its use in prediabetes is lacking, treating insomnia with CBT has not shown any major side effects. This makes it a promising option for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SHUTi because it offers a unique, digital approach to managing insomnia in people with prediabetes. Unlike traditional therapies that might involve medication or in-person therapy sessions, SHUTi is an internet-delivered program based on cognitive behavioral therapy for insomnia (CBT-I). This means it can be accessed anytime and anywhere via devices like smartphones or computers, providing flexibility and convenience. By focusing on changing sleep habits and correcting misconceptions about insomnia, SHUTi aims to improve sleep health in a way that's both accessible and evidence-based.

What evidence suggests that digital cognitive behavioral therapy is effective for prediabetes?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) can lower blood sugar levels in people with prediabetes. In this trial, participants will receive either the digital CBT-I program SHUTi or a Patient Education intervention. Studies have found that lifestyle changes taught in CBT-I help more people achieve normal blood sugar levels. Past research demonstrated that CBT-I improved sleep quality and reduced blood sugar levels, particularly in those with type 2 diabetes. The digital CBT-I program SHUTi, which employs these methods, has been well-studied and proven to improve insomnia symptoms. This suggests it might also help manage blood sugar levels in prediabetes. ^{1 2 3 6 7}

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

I have trouble sleeping.

Regular access to device with internet access

Adequate data at baseline

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.

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?

Group I: Digital cognitive behavioral therapy (dCBT-I) Experimental Treatment 1 Intervention

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.

Group II: Patient Education (PE) Active Control 1 Intervention

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.

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

Approved in United States as Somryst for:

• Chronic insomnia disorder

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

Prediabetes is a significant health concern that increases the risk of developing type 2 diabetes (T2DM) and associated complications, but it can be effectively managed through lifestyle changes and medications.

Various treatments, including lifestyle interventions, medications like metformin and GLP-1 receptor agonists, and even bariatric surgery, have been shown to prevent or delay the progression from prediabetes to T2DM, highlighting the importance of individualized management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating prediabetes: why and how should we do it? Braga, T., Kraemer-Aguiar, LG., Docherty, NG., et al.[2019]

Impaired glucose tolerance (IGT) is a critical stage in prediabetes, and addressing it through lifestyle changes and pharmacological interventions can significantly delay the onset of type 2 diabetes.

Current pharmacological treatments for prediabetes are still in early development, but there is promising research on both traditional Chinese medicine and new drug techniques aimed at preventing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Recent advances in pharmacological intervention for prediabetes]. Lan, JQ., Zhu, CJ.[2018]

Individuals with prediabetes, characterized by impaired fasting glucose (IFG) and impaired glucose tolerance (IGT), are at a significant risk of developing type 2 diabetes, with about 25% progressing to diabetes within three to five years.

Lifestyle changes and drug interventions, particularly metformin, are effective in delaying or preventing the onset of type 2 diabetes in prediabetes patients, highlighting the importance of early therapeutic interventions to prevent chronic complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prediabetes: diagnosis, evaluation of chronic complications, and treatment]. Souza, CF., Gross, JL., Gerchman, F., et al.[2019]

In a study using the SHROB model of prediabetes, the DPP-IV inhibitor sitagliptin effectively reduced glucagon levels by 33%, while standard therapy with glyburide did not change glucagon levels.

Sitagliptin not only improved insulin secretion in response to glucose but also delayed the peak insulin response compared to glyburide, suggesting it may be a more effective treatment for managing prediabetes in this model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sitagliptin lowers glucagon and improves glucose tolerance in prediabetic obese SHROB rats. Chen, B., Moore, A., Escobedo, LV., et al.[2018]

Prediabetes, characterized by impaired fasting glucose or glucose tolerance, is linked to a higher risk of metabolic syndrome and cardiovascular issues, highlighting the importance of early intervention.

Effective management of prediabetes includes weight loss and regular physical activity, with certain medications also being recommended to help prevent the progression to Type 2 diabetes and cardiovascular diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediabetes. Rosolová, H.[2022]

A survey of 117 doctors in India revealed that while lifestyle modifications are commonly recommended for managing prediabetes, many practitioners prefer using metformin, with voglibose emerging as a popular second-line treatment option.

Voglibose, recently approved in Japan for prediabetes management, is considered relevant by most Indian doctors, although only about half have prescribed it, indicating a potential for increased adoption in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of voglibose in the treatment of prediabetes in Indian population: a cross-speciality survey. Dewda, PR., Agrawal, S.[2021]

Early loss of β-cell function occurs in individuals with prediabetes and continues to decline in those with type 2 diabetes mellitus (T2DM), even with standard treatments, highlighting the need for early intervention.

Lifestyle changes and certain medications, such as thiazolidinediones and GLP-1 agonists, may help preserve or enhance β-cell function, potentially delaying the onset of T2DM and reducing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choice of early treatment regimen and impact on β-cell preservation in type 2 diabetes. Mudaliar, S.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A conceptual framework for targeting prediabetes with lifestyle, clinical, and behavioral management interventions. Biuso, TJ., Butterworth, S., Linden, A.[2007]

Prediabetes significantly increases the risk of developing type 2 diabetes mellitus (T2DM) by 3- to 10-fold, making early identification and management crucial to prevent complications associated with high blood sugar levels.

For patients aged 65 and older, the first-line treatment for prediabetes is lifestyle modifications such as exercise, nutrition, and weight loss, with pharmacological therapies available to help manage glucose and other related health parameters when necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediabetes in a nursing facility patient with renal insufficiency. Shane-McWhorter, L.[2010]

Prediabetes significantly increases the risk of developing type 2 diabetes and is associated with complications similar to those seen in diabetes, highlighting the importance of early intervention.

Intensive lifestyle changes and metformin have been shown to effectively prevent or delay the onset of type 2 diabetes in individuals with prediabetes, with lifestyle interventions generally being more effective, and long-term follow-ups indicate that early interventions can lead to lasting health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular complications in prediabetes and type 2 diabetes: a continuous process arising from a common pathology. Gottwald-Hostalek, U., Gwilt, M.[2022]

Intensive lifestyle modifications and certain oral antidiabetic medications, such as metformin, can effectively prevent or delay the progression from prediabetes to type 2 diabetes, highlighting the importance of early intervention.

Management of prediabetes should prioritize lifestyle changes and addressing multiple risk factors, with the option of using medications for individuals at high risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of prediabetes. Priya, G.[2022]

A study involving 35 adults with prediabetes revealed that many patients overestimate their risk of developing diabetes and lack knowledge about effective treatment options, highlighting a need for better education in primary care.

Most participants found both intensive lifestyle changes and metformin acceptable as treatment options, with a preference for starting with lifestyle interventions, suggesting that personalized counseling could motivate patients to take action against prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Perceptions About Prediabetes and Preferences for Diabetes Prevention. O'Brien, MJ., Moran, MR., Tang, JW., et al.[2018]

Citations

1.

research.kpchr.org

research.kpchr.org/News/CHR-Stories/Study-Tests-Treating-Insomnia-to-Prevent-Diabetes

Study Tests Treating Insomnia to Prevent Diabetes

The study will test whether a sleep treatment called Cognitive Behavioral Therapy for Insomnia (CBT-I) results in lower blood sugar for people with prediabetes.

2.

withpower.com

withpower.com/trial/phase-sleep-initiation-and-maintenance-disorders-7-2023-21f40

Cognitive Behavioral Therapy for Prediabetes

Lifestyle modification interventions are the most effective approach for reversing prediabetes, with 18% more participants achieving normal glucose levels ...

3.

ctv.veeva.com

ctv.veeva.com/study/sleep-for-health-study-on-the-effects-of-cognitive-behavioral-therapy-for-insomnia-on-diabetes-risk

Sleep for Health Study on the Effects of Cognitive Behavioral ...

This study tests whether providing cognitive behavioral therapy for insomnia (CBT-I) to people with prediabetes results in a reduction in

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7958479/

Effectiveness of cognitive behavior therapy for sleep ...

CBT delivered by general practitioners, as an effective and practical method, could reduce glycemic levels and improve sleep quality for patients with T2DM in ...

5.

biospace.com

biospace.com/pear-therapeutics-announces-data-from-two-studies-evaluating-prescription-digital-therapeutics-pdts-for-chronic-insomnia-presented-at-world-sleep-congress-2022

Pear Therapeutics Announces Data from Two Studies ...

Results found treated participants achieved significant reductions in ISI score (15.9 at baseline, 10.0 at ten weeks, 9.1 at six months and 8.9 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11955987/

Diabetes and Wellness Smartphone Applications for Self ...

Diabetes self-management plays a vital role in improving clinical outcomes and the quality of life of individuals living with diabetes.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33226269/

Profile of Somryst Prescription Digital Therapeutic for ...

Areas covered: This review summarizes the mechanisms of action and technical features of Somryst, and describes safety and effectiveness data ...