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

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{7 11 12 13 14}

Research Team

Erin LeBlanc, MD

Principal Investigator

Kaiser Permanente

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Interventions for Reversing Prediabetes: A Systematic Review and Meta-Analysis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A conceptual framework for targeting prediabetes with lifestyle, clinical, and behavioral management interventions. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

Prediabetes in a nursing facility patient with renal insufficiency. [2010]

5. England pubmed.ncbi.nlm.nih.gov

Vascular complications in prediabetes and type 2 diabetes: a continuous process arising from a common pathology. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Patient Perceptions About Prediabetes and Preferences for Diabetes Prevention. [2018]

7. Italy pubmed.ncbi.nlm.nih.gov

Treating prediabetes: why and how should we do it? [2019]

8. England pubmed.ncbi.nlm.nih.gov

Sitagliptin lowers glucagon and improves glucose tolerance in prediabetic obese SHROB rats. [2018]

9. India pubmed.ncbi.nlm.nih.gov

Role of voglibose in the treatment of prediabetes in Indian population: a cross-speciality survey. [2021]

10. India pubmed.ncbi.nlm.nih.gov

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

11. Pakistan pubmed.ncbi.nlm.nih.gov

Management of prediabetes. [2022]

12. Brazil pubmed.ncbi.nlm.nih.gov

[Prediabetes: diagnosis, evaluation of chronic complications, and treatment]. [2019]

13. Czech Republic pubmed.ncbi.nlm.nih.gov

Prediabetes. [2022]

14. China pubmed.ncbi.nlm.nih.gov

[Recent advances in pharmacological intervention for prediabetes]. [2018]