CGM + Behavioral Intervention for Type 2 Diabetes

Overseen By Karina Davidson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Dialysis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how pairing continuous glucose monitoring (CGM) with behavior-changing text messages can help manage blood sugar and reduce diabetes-related stress in people with type 2 diabetes. Participants will use a CGM sensor and a Fitbit to track their blood sugar and activity levels over 10 weeks. They will experience two different interventions: one focusing on physical activity and the other on mood, known as Action Planning for Mood. Ideal participants have type 2 diabetes with poor blood sugar control, experience stress related to their diabetes, and can walk and use a smartphone. As an unphased trial, this study offers a unique opportunity to explore innovative ways to manage diabetes and improve quality of life.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, but you should confirm with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study linked continuous glucose monitoring (CGM) to better outcomes for people with type 2 diabetes, such as reducing the risk of severe low blood sugar episodes. This finding indicates that CGM is generally safe and well-tolerated. The FDA has approved CGM systems for tracking blood sugar levels, further supporting their safety.

For mood-related interventions, research has shown that combining behavior change techniques can help manage diabetes and improve mood. These techniques aim to reduce stress and enhance overall well-being, which benefits diabetes management.

Regarding physical activity, studies have found that self-monitoring can help increase physical activity levels in people with type 2 diabetes. This method is generally safe and supports making healthy lifestyle changes.

Overall, previous research considers the treatments in this trial safe. Each component has been tested before and shown to be helpful without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how combining continuous glucose monitoring (CGM) with behavioral interventions might better manage Type 2 diabetes. Unlike standard treatments that often focus on medication alone, this approach uses technology to provide real-time data and pairs it with targeted lifestyle changes via daily text messages. By alternating focus between mood and physical activity, the trial aims to tackle both psychological and physical aspects of diabetes management. This could lead to more personalized and effective care, potentially improving both glucose control and overall well-being for patients.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that continuous glucose monitoring (CGM) can help people with type 2 diabetes better control their blood sugar. Studies have found a small but significant reduction in average blood sugar levels (HbA1c) by about 0.32%, along with more time spent in a healthy blood sugar range. In this trial, participants will receive CGM paired with behavior change technique interventions. One group will begin with a mood intervention, while the other will start with a physical activity intervention. Techniques such as cognitive behavioral therapy can help manage blood sugar and reduce diabetes-related stress. Tracking physical activity also shows promise. Using wearable devices, individuals have improved their activity levels and health markers like HbA1c and BMI. Together, these methods may help manage type 2 diabetes more effectively. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 45 with type 2 diabetes who are able to walk and use a smartphone. They should have high blood sugar levels (A1C ≥8.0%) and feel stressed about their diabetes. People using dialysis, pregnant women, non-English speakers, or those unable to follow the study plan can't join.

Inclusion Criteria

Suboptimal hemoglobin A1C (≥8.0%)

Access to and capable of using a smart cellular phone

I am 45 years old or older.

Exclusion Criteria

Inability to comply with study protocol during 2-week run-in

Currently using CGM

Unavailable for follow-up

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline/Run-in

Participants' usual blood glucose and physical activity are monitored

2 weeks

1 visit (in-person)

Intervention

Participants receive CGM paired with behavioral interventions for physical activity and mood in alternating two-week blocks

8 weeks

4 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Action Planning for Mood
• Self-Monitoring of Behavior for Mood
• Self-Monitoring of Behavior for Physical Activity

Trial Overview

The study tests if continuous glucose monitoring combined with text messages encouraging physical activity or improving mood helps control blood sugar and reduces stress in diabetics. Participants wear sensors and get alternating interventions every two weeks for eight weeks after an initial observation period.

How Is the Trial Designed?

Group I: CGM paired with behavior change technique interventions, physical activity intervention first Experimental Treatment 4 Interventions

Participants in this arm will receive a continuous glucose monitor and they will receive two behavior change technique interventions via daily text messages over the course of eight weeks, in a series of four, two-week blocks. In the first two-week block, they will receive the physical activity behavior change technique intervention. In the second and third two-week blocks, they will receive the mood behavior change technique intervention. In the fourth two-week block, they will receive the physical activity behavior change technique intervention.

Group II: CGM paired with behavior change technique interventions, mood intervention first Experimental Treatment 4 Interventions

Participants in this arm will receive a continuous glucose monitor and they will receive two behavior change technique interventions via daily text messages over the course of eight weeks, in a series of four, two-week blocks. In the first two-week block, they will receive the mood behavior change technique intervention. In the second and third two-week blocks, they will receive the physical activity behavior change technique intervention. In the fourth two-week block, they will receive the mood behavior change technique intervention.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study involving 66 adults with bipolar disorder, the majority preferred the Body Media SW Pro Armband for physical activity monitoring, despite reporting various issues with the devices, such as irritation and movement.

About 64% of participants experienced problems with at least one monitor, but these issues did not significantly affect their preferences, indicating that individuals with bipolar disorder are generally open to using activity monitors for tracking physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Monitoring Preferences in Adults With Bipolar Disorder. Janney, CA., Ducheine, AR., Reichmann, R., et al.[2021]

Self-management strategies for individuals with bipolar disorder (BD), such as psychoeducation, mood monitoring, and healthy lifestyle choices, have been shown to be effective and can be tailored to individual needs for better outcomes.

Longer and more frequent self-management interventions are recommended to maximize benefits, and collaboration between clinicians and patients is essential to integrate these strategies with traditional medical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management and bipolar disorder--a clinician's guide to the literature 2011-2014. Janney, CA., Bauer, MS., Kilbourne, AM.[2022]

Continuous glucose monitoring (CGM) was found to be feasible and acceptable for 27 non-insulin-using adults with type 2 diabetes, with 82% accurately logging their dietary and exercise events despite some difficulties in entering data.

CGM provided valuable insights, identifying 141 dietary and 71 exercise-teaching events, indicating its potential to enhance behavioral interventions for managing diabetes, even though some participants experienced minor discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in non-insulin-using individuals with type 2 diabetes: acceptability, feasibility, and teaching opportunities. Allen, NA., Fain, JA., Braun, B., et al.[2022]

In a study of 65 patients with poorly controlled type 2 diabetes, those using a real-time continuous glucose monitoring system (RT-CGM) showed a significant reduction in HbA1c levels from 9.1% to 8.0% over 12 weeks, compared to a smaller reduction in the self-monitoring blood glucose (SMBG) group.

The RT-CGM group also experienced improvements in lifestyle factors, including reduced calorie intake, weight loss, lower body mass index (BMI), and increased exercise time, indicating that RT-CGM not only aids in glucose control but also promotes healthier habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes. Yoo, HJ., An, HG., Park, SY., et al.[2022]

Continuous glucose monitoring (CGM) significantly enhances self-management in people with type 2 diabetes (PwT2D) by providing personalized data that motivates behavior changes, as reported by 13 participants in a qualitative study.

While CGM improves health outcomes and relationships with healthcare providers, challenges such as costs and discomfort with the device were noted, indicating a need for further development of supportive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Continuous Glucose Monitoring Can Motivate Self-management: Can Motivation Follow Behaviour? Vallis, M., Ryan, H., Berard, L., et al.[2023]

A study involving 308 individuals with bipolar disorder revealed that personalized monitoring questions, beyond standard mood symptoms, provided valuable insights into patient priorities, with common themes including physical activity, anxiety, sleep, and coping.

The findings suggest that monitoring aspects of life beyond mood symptoms can enhance understanding of bipolar disorder, indicating that traditional symptom-based assessments may overlook important factors that patients themselves find significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Have I argued with my family this week?": What questions do those with lived experience choose to monitor their bipolar disorder? Gordon-Smith, K., Saunders, KE., Savage, J., et al.[2021]

An 18-item survey was created to assess how real-time continuous glucose monitoring (CGM) influences patients' behavior regarding food choices and physical activity.

The study highlights a gap in data regarding the effectiveness of CGM in promoting lifestyle changes among users, suggesting that more research is needed to understand its impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring As a Behavior Modification Tool. Ehrhardt, N., Al Zaghal, E.[2021]

In a study of 302 patients with type 2 diabetes, the use of professional continuous glucose monitoring (CGM) significantly reduced HbA1c levels by an average of 0.439% compared to a control group, indicating improved glycemic control.

The CGM intervention also led to better glucose management, with increased time spent in the target glucose range, reduced time above 180 mg/dl, decreased glycemic variability, and improved dietary habits, including a reduction in daily caloric intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of professional continuous glucose monitoring as an adjuvant educational tool for improving glycemic control in patients with type 2 diabetes. Rivera-Ávila, DA., Esquivel-Lu, AI., Salazar-Lozano, CR., et al.[2022]

The MONARCA II trial is testing a new smartphone system that combines subjective and objective measures to help manage bipolar disorder symptoms over a 9-month period, comparing it to regular smartphone use.

Preliminary findings from the MONARCA I trial indicated that while patients using the electronic self-monitoring system had more sustained depressive symptoms, they experienced fewer manic symptoms, suggesting potential benefits in managing mood fluctuations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily electronic monitoring of subjective and objective measures of illness activity in bipolar disorder using smartphones--the MONARCA II trial protocol: a randomized controlled single-blind parallel-group trial. Faurholt-Jepsen, M., Vinberg, M., Frost, M., et al.[2019]

In a study involving 402 diabetes patients, those who created implementation plans significantly increased their self-monitoring of blood glucose (SMBG) rates, checking their blood sugar up to 7.77 times more than control groups over a 2-week period.

The use of implementation planning as a strategy effectively improved patient self-monitoring behavior, suggesting it could be a valuable tool for enhancing diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple and promising tool to improve self-monitoring of blood glucose in patients with diabetes. Nadkarni, A., Kucukarslan, SN., Bagozzi, RP., et al.[2022]

A multidisciplinary group of 16 experts identified 12 patient-reported outcome measures (PROMs) suitable for assessing the psychosocial impact of continuous glucose monitors (CGMs) on pediatric patients with Type 1 diabetes (T1D), focusing on areas like diabetes distress and quality of life.

The study established a quarterly administration schedule for these PROMs, aiming to minimize participant burden while providing valuable insights into the psychosocial well-being of children with T1D using CGMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified e-Delphi Process for the Selection of Patient-Reported Outcome Measures for Children and Families With Type 1 Diabetes Using Continuous Glucose Monitors: Delphi Study. Shah, P., Raymond, JK., Espinoza, J.[2023]

Continuous glucose monitoring (CGM) shows a high level of agreement with traditional reference glucose measurements in individuals with type 1 diabetes, indicating it can be a reliable tool for assessing glucose levels in clinical studies.

Despite some minor discrepancies in extreme glucose values, CGM can effectively capture overall glycemic control and variability, making it a valuable outcome measure for clinical trials involving diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of continuous glucose monitoring as an outcome measure in clinical trials. Beck, RW., Calhoun, P., Kollman, C.[2022]

Smartphone-based electronic self-monitoring can effectively reflect depressive and manic symptoms in bipolar disorder, allowing for long-term tracking of mood instability, but it has not shown to reduce the severity of these symptoms in a randomized controlled trial.

Electronic monitoring of psychomotor activity and heart rate variability may serve as objective markers of illness activity in bipolar disorder, highlighting the potential for innovative, on-demand interventions, though concerns about patient safety and data privacy must be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic monitoring in bipolar disorder. Faurholt-Jepsen, M.[2018]

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