Cognitive Behavioral Therapy + CGM for Type 1 Diabetes

(ReDUCe Trial)

Recruiting at 1 trial location

Overseen By Shivani Agarwal, MD, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Must not be taking: Psychiatric medications

Disqualifiers: Depression, Anxiety, Suicidality, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

93 Participants Needed

Trial Summary

What is the purpose of this trial?

This project proposes to use telemedicine-delivered cognitive-behavioral therapy (CBT) enhanced with continuous glucose monitor (CGM) review to target diabetes distress in adults with type 1 diabetes. The efficacy of CBT for diabetes distress (CBT-DD) will be tested in comparison to commercial FDA-approved CGM only in a randomized controlled clinical trial. The investigators' central hypothesis is that the addition of a CBT intervention that targets diabetes distress and self-management directly will yield clinically significant improvements in both diabetes distress and glycemic control relative to CGM alone. The investigators propose to recruit 93 adults (age 18-64) with type 1 diabetes from a national population for an entirely virtual 6-month study over four years, with targeted recruitment of racial/ethnic minorities. In addition to standard measurement of HbA1c for glycemic control and validated patient-reported outcome (PRO) surveys, the investigators plan to innovatively integrate momentary psychological and behavioral data via smartphone-based ecological momentary assessment with CGM data to assess day-to-day changes in diabetes distress, affect, self-management, and glycemia over the course of the trial.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on psychiatric medication, your dose must have been stable for the past 2 months.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy + CGM for Type 1 Diabetes?

Research shows that internet-based cognitive behavioral therapy (CBT) is effective for reducing depression in people with diabetes, and telemedicine programs using continuous glucose monitoring (CGM) can significantly reduce diabetes-related distress. These findings suggest that combining CBT with CGM could help manage emotional and psychological challenges in individuals with type 1 diabetes. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy combined with Continuous Glucose Monitoring safe for humans?

Cognitive Behavioral Therapy (CBT) and Continuous Glucose Monitoring (CGM) have been studied separately and are generally considered safe for people with diabetes, including those with psychological distress. Studies show that CGM can improve well-being and alleviate fear of low blood sugar, while CBT is effective for managing depression in diabetes. ^{1 3 6 7 8}

How does the treatment Cognitive Behavioral Therapy + CGM for Type 1 Diabetes differ from other treatments for this condition?

This treatment is unique because it combines Cognitive Behavioral Therapy (CBT) to address diabetes-related emotional distress with Continuous Glucose Monitoring (CGM) to help manage blood sugar levels, all delivered through telemedicine. This approach not only targets the psychological aspects of living with type 1 diabetes but also provides real-time data to improve diabetes management, which is not typically addressed together in standard treatments. ^{1 3 4 8 9}

Research Team

Jeffrey Gonzalez, PhD

Principal Investigator

Yeshiva University

Eligibility Criteria

This trial is for young adults aged 18-30 with Type 1 Diabetes who experience diabetes distress. They must have been on a stable insulin treatment for at least 3 months, have had diabetes for over half a year, and speak English or Spanish. Not eligible if pregnant, in another study, recently treated for psychological conditions, on unstable psychiatric meds, or have certain disabilities.

Inclusion Criteria

I speak English or Spanish.

Your HbA1c level is between 7.5% and 14%.

Criterion: Feeling very worried or overwhelmed because of diabetes.

Exclusion Criteria

I have a mental health condition like depression or anxiety.

You have been receiving treatment for a mental health condition in the past 6 months.

You are currently pregnant, because your treatment and goals for managing blood sugar are different during pregnancy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Virtual screening

Run-in

Participants undergo a 2-week run-in period with daily ecological momentary assessment (EMA) data collection

2 weeks

Daily virtual assessments

Treatment

Participants receive an 8-week Cognitive Behavioral Therapy (CBT) intervention with weekly EMA data collection

8 weeks

Weekly virtual CBT sessions

Post-intervention

Participants undergo a 2-week post-intervention period with daily EMA data collection

2 weeks

Daily virtual assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, with virtual data collection at 3, 6, 9, and 12 months

12 months

Virtual follow-up at 3, 6, 9, and 12 months

Treatment Details

Interventions

• Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring
• Continuous Glucose Monitoring (CGM)
• Telemedicine-Delivered Cognitive Behavioral Therapy

Trial Overview The trial tests whether Cognitive Behavioral Therapy (CBT) aimed at reducing diabetes-related stress works better when combined with Continuous Glucose Monitoring (CGM) than just using CGM alone. It's a virtual study where participants are randomly placed into two groups to compare the effects over six months.

Participant Groups

Group I: Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring Experimental Treatment 2 Interventions

Participants randomized to this arm will receive Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD), enhanced by review of Continuous Glucose Monitoring (CGM) data. Participants will wear study-supplied CGM for the first 6 months of their participation in the trial.

Group II: Continuous Glucose Monitoring (CGM) Only Active Control 1 Intervention

Participants randomized to receive Continuous Glucose Monitoring (CGM) will continue to receive their usual care and will also wear CGM throughout the first 6 months of their participation in the trial.

Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring is already approved in United States for the following indications:

Approved in United States as CBT-DD for:

• Diabetes distress in adults with type 1 diabetes

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

DexCom, Inc.

Industry Sponsor

Trials

151

Recruited

35,700+

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Findings from Research

A 10-week internet-based cognitive behavioral therapy (iCBT) program significantly reduced depression and diabetes-related distress in participants with major depressive disorder and diabetes, showing superior outcomes compared to treatment as usual (TAU).

The iCBT program led to a 51% clinically significant improvement in depression scores, with 87% of participants no longer meeting criteria for major depressive disorder at follow-up, indicating its efficacy as an accessible treatment option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Cognitive Behavior Therapy for Depression in People With Diabetes Mellitus: A Randomized Controlled Trial. Newby, J., Robins, L., Wilhelm, K., et al.[2018]

The study found that 19.6% of adult patients with Type 2 diabetes experience diabetes distress (DD), which is significantly higher in younger patients (≤45 years) and those with poor blood sugar control (HbA1c >8%).

Patients on insulin therapy reported 5.4 times more DD compared to those on oral medications, and those with a history of treatment interruption had an 11 times higher risk of experiencing DD, indicating that treatment adherence and age are critical factors in managing the emotional burden of diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying the Burden and Predictors of Diabetes Distress among Adult Type 2 Diabetes Mellitus Patients. Ratnesh, ., Shivaprasad, KS., Kannan, S., et al.[2022]

A new Internet-based program combining cognitive-behavioral therapy with diabetes education is being tested for its effectiveness in treating mild to moderate depression in adults with type 1 diabetes, through a randomized controlled trial involving participants over a 9-week intervention period.

The study aims to assess not only the reduction in depressive symptoms but also improvements in related factors such as anxiety, quality of life, and glycemic control, with evaluations occurring at multiple time points after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based Cognitive-behavioral therapy (CBT) for depressive symptomatology in individuals with type 1 diabetes (WEB_TDDI1 study): A randomized controlled trial protocol. Carreira, M., Ruiz de Adana, MS., Pinzón, JL., et al.[2022]

Participants in the Onduo Virtual Diabetes Clinic, a telehealth program for type 2 diabetes, experienced significant reductions in diabetes distress, with scores decreasing from 3.0 to 2.5 over an average of 6 months (P <0.001).

Those using real-time continuous glucose monitoring (rtCGM) reported even greater reductions in distress, particularly in regimen-related distress, highlighting the potential effectiveness of telemedicine and technology in managing diabetes-related emotional challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Participation in a Virtual Diabetes Clinic on Diabetes-Related Distress in Individuals With Type 2 Diabetes. Polonsky, WH., Layne, JE., Parkin, CG., et al.[2021]

A web-based, diabetes-specific cognitive behavioral therapy (CBT) for depression was found to be effective for patients with diabetes, regardless of the severity of their mental health issues, including those with major depressive disorder or anxiety disorders.

The study involved 255 patients and showed that the effectiveness of the CBT treatment did not differ based on the presence of severe mental health problems, indicating it is suitable for a wide range of patients with diabetes experiencing depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is a severe clinical profile an effect modifier in a Web-based depression treatment for adults with type 1 or type 2 diabetes? Secondary analyses from a randomized controlled trial. van Bastelaar, KM., Pouwer, F., Cuijpers, P., et al.[2022]

In a study of 16 children with type 1 diabetes using continuous glucose monitoring (CGM) for at least 12 months, there was no significant improvement in glycemic control as measured by glycated hemoglobin levels.

However, both parents and children reported a significant reduction in fear of hypoglycemia after using CGM, indicating that while CGM may not improve metabolic control, it can enhance psychological well-being regarding hypoglycemia fears.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring in Children with Type 1 Diabetes Improves Well-Being, Alleviates Worry and Fear of Hypoglycemia. Ng, SM., Moore, HS., Clemente, MF., et al.[2020]

In a study of 52 patients with type 1 diabetes and impaired awareness of hypoglycemia, continuous glucose monitoring (CGM) significantly improved time spent in the target blood sugar range compared to self-monitoring, with a 9.6% increase (P < 0.0001).

The effectiveness of CGM was consistent regardless of the level of psychological distress experienced by patients, indicating that CGM can provide glycemic benefits for both high and low distressed individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring in Patients with Type 1 Diabetes and Impaired Awareness of Hypoglycemia: Also Effective in Patients with Psychological Distress? van Beers, CAJ., de Wit, M., Kleijer, SJ., et al.[2018]

A family behavioral intervention (FBI) was developed to support the use of continuous glucose monitors (CGMs) in young children with type 1 diabetes, based on input from parents and mixed-methods research.

The intervention was successfully implemented in a clinical trial with high fidelity and participant satisfaction, as 89% of participants completed all sessions and over 80% rated their satisfaction very high, indicating strong feasibility for future use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and delivery of a brief family behavioral intervention to support continuous glucose monitor use in young children with type 1 diabetes. Hilliard, ME., Commissariat, PV., Kanapka, L., et al.[2023]

A study involving 200 youths with type 1 diabetes showed that using the GlucoWatch G2 Biographer (CGM) for 6 months did not lead to significant psychological benefits or adverse effects, indicating a neutral impact on mental health.

The research highlighted that youths whose parents reported better treatment adherence and diabetes-related quality of life were more likely to use the CGM frequently, suggesting that certain family characteristics may influence the effectiveness of CGM use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological aspects of continuous glucose monitoring in pediatric type 1 diabetes. , .[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Web-Based Cognitive Behavior Therapy for Depression in People With Diabetes Mellitus: A Randomized Controlled Trial. [2018]

2. India pubmed.ncbi.nlm.nih.gov

Identifying the Burden and Predictors of Diabetes Distress among Adult Type 2 Diabetes Mellitus Patients. [2022]

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

Internet-based Cognitive-behavioral therapy (CBT) for depressive symptomatology in individuals with type 1 diabetes (WEB_TDDI1 study): A randomized controlled trial protocol. [2022]

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

Impact of Participation in a Virtual Diabetes Clinic on Diabetes-Related Distress in Individuals With Type 2 Diabetes. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

Is a severe clinical profile an effect modifier in a Web-based depression treatment for adults with type 1 or type 2 diabetes? Secondary analyses from a randomized controlled trial. [2022]

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

Continuous Glucose Monitoring in Children with Type 1 Diabetes Improves Well-Being, Alleviates Worry and Fear of Hypoglycemia. [2020]

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

Continuous Glucose Monitoring in Patients with Type 1 Diabetes and Impaired Awareness of Hypoglycemia: Also Effective in Patients with Psychological Distress? [2018]

8. Denmark pubmed.ncbi.nlm.nih.gov

Development and delivery of a brief family behavioral intervention to support continuous glucose monitor use in young children with type 1 diabetes. [2023]

9. Denmark pubmed.ncbi.nlm.nih.gov

Psychological aspects of continuous glucose monitoring in pediatric type 1 diabetes. [2022]