214 Participants NeededMy employer runs this trial

CGM-Enhanced DPP for Prediabetes

(CGM-DPP Trial)

JS
RA
Overseen ByRaphael A Fraser, PhD, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: State University of New York at Buffalo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining continuous glucose monitoring (CGM) with the Diabetes Prevention Program (DPP) can help people with prediabetes adhere more effectively to healthy lifestyle changes. Prediabetes, a condition where blood sugar levels are higher than normal but not yet classified as diabetes, increases the risk of developing type 2 diabetes and heart disease. The trial compares two groups: one uses CGM devices with coaching, while the other follows the standard DPP without CGM. Eligible participants have been diagnosed with prediabetes and are willing to use CGM devices and attend coaching sessions. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance diabetes prevention strategies.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for prediabetes management?

Research has shown that continuous glucose monitoring (CGM) is generally safe for people with diabetes. Studies indicate that CGM users often achieve better blood sugar control and feel more satisfied with their diabetes management. Although less information exists on CGM use for prediabetes, its success with diabetes suggests potential benefits. The technology is approved for diabetes management, indicating a strong safety record. Most people tolerate CGM well, with few reports of serious side effects. Some users might experience mild skin irritation at the attachment site, but this is usually easy to manage.12345

Why are researchers excited about this trial?

Researchers are excited about the CGM-Enhanced Diabetes Prevention Program (DPP) for prediabetes because it combines traditional lifestyle changes with modern technology, potentially offering a more personalized approach to managing blood sugar levels. Unlike standard options, which generally involve only lifestyle and dietary changes, this method uses Continuous Glucose Monitors (CGMs) to provide real-time feedback and coaching. This allows individuals to see the immediate impact of their lifestyle choices on their blood sugar, promoting more effective and sustained behavioral changes. By integrating technology with health coaching, this approach could lead to more successful prevention of diabetes progression.

What evidence suggests that this trial's treatments could be effective for prediabetes?

This trial will compare the effectiveness of the Diabetes Prevention Program (DPP) alone with the DPP enhanced by continuous glucose monitors (CGM) and coaching. Research has shown that using a CGM with the DPP can effectively manage prediabetes. Studies have found that CGM helps people understand how diet and exercise affect blood sugar, encouraging healthier choices. Real-time CGM with digital coaching has improved blood sugar control in those with prediabetes. Additionally, research indicates that the lifestyle changes encouraged by the DPP can significantly lower the risk of developing type 2 diabetes. Combining these methods may help people maintain healthy habits long-term and improve overall health outcomes.14567

Are You a Good Fit for This Trial?

This trial is for adults 18 or older with prediabetes (slightly high blood sugar), a BMI of at least 24 (or 22 for Asian Americans), and who are willing to attend coaching sessions and use a continuous glucose monitor.

Inclusion Criteria

I am 18 years old or older.
I have been diagnosed with prediabetes based on my blood sugar levels.
My BMI is at least 24, or 22 if I'm Asian American.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a 12-month program combining DPP coaching with continuous glucose monitoring

12 months
Regular check-ins

Follow-up

Participants are monitored for changes in glycemic control, quality of life, and self-care activities

12 months post intervention

What Are the Treatments Tested in This Trial?

Interventions

  • CGM-DPP

Trial Overview

The study compares two groups: one gets Diabetes Prevention Program (DPP) lifestyle coaching plus continuous glucose monitoring (CGM), while the other receives standard DPP coaching without CGM. The goal is to see if adding CGM helps people stick to healthy habits better.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials
279
Recruited
52,600+

Citations

CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults ...

The study will involve 214 adults with prediabetes who will follow a 12-month program with regular check-ins to measure improvements in blood sugar control, ...

Adding a Brief Continuous Glucose Monitoring Intervention to ...

Continuous glucose monitoring (CGM) has shown potential to raise awareness about the effects of diet and activity on glucose among people with ...

NIDDK's Journey Into the Prevention of Type 2 Diabetes and ...

After mean 2.8 years, ILS reduced diabetes risk by 58% and metformin by 31%, leading to study termination ahead of schedule due to demonstrated ...

Impact of real-time continuous glucose monitoring and ...

Real-time CGM with digital coaching improved glycemic control in T2DM and prediabetes. · High glycemic variability group showed the greatest HbA1c reduction ...

Continuous Glucose Monitoring in Prediabetes

This research explores how wearable glucose monitors might help prevent type 2 diabetes in people at risk of developing the disease. Type 2 diabetes affects ...

Continuous Glucose Monitoring for Prediabetes

Continuous glucose monitoring (CGM) has transformed the care of patients with diabetes, and there is great potential to extend these benefits to prediabetes.

Advances in Continuous Glucose Monitoring: Clinical ... - PMC

Studies show that people with diabetes (PwD) using CGM achieve better glycemic outcomes and greater satisfaction with their diabetes management.