CGM Device for Diabetes

(Salud Diabetes Trial)

Overseen By David Kerr, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sutter Health

Must not be taking: Steroids, Protease inhibitors

Disqualifiers: Type 1 diabetes, Insulin use, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how a produce prescription program affects blood sugar levels in Hispanic/Latino adults with type 2 diabetes who aren't using insulin but have high HbA1c levels (a measure of blood sugar over time). Participants receive fruits, vegetables, and continuous glucose monitoring (CGM) devices to track their blood sugar. It suits those who have had type 2 diabetes for a while, have an HbA1c of 9% or higher, and aren't currently using insulin. As an unphased trial, this study offers a unique opportunity to explore innovative ways to manage diabetes without insulin.

Will I have to stop taking my current medications?

The trial requires that you do not use steroids or medications that impact glucose levels, such as certain antipsychotics, corticosteroids, and other specified drugs. If you are taking any of these, you may need to stop them to participate.

What prior data suggests that this CGM device is safe for use in diabetes management?

Research shows that Continuous Glucose Monitors (CGMs) are generally safe and easy to use. Studies have found that CGMs help people manage their blood sugar levels effectively, which is especially beneficial for those with diabetes. These devices allow users to monitor if blood sugar is too high or too low.

The FDA has evaluated the safety of these devices and found them effective when used correctly. Some individuals might experience mild skin irritation from the sensor, which adheres to the skin. However, this irritation is usually minor. Overall, experts recommend CGMs for people with diabetes, including those with Type 2 diabetes, which is the focus of this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CGM Device for Diabetes trial because it's exploring a novel approach to managing diabetes through a combination of continuous glucose monitoring (CGM) devices and a diet focused solely on fruits and vegetables. Unlike standard diabetes treatments that often rely on medications like insulin or oral hypoglycemics, this trial emphasizes non-pharmacological management. The use of CGM devices offers real-time glucose tracking, empowering patients with immediate feedback to better manage their condition. By pairing this technology with a specific diet, researchers hope to uncover potential benefits in blood sugar control, which could provide a more holistic and lifestyle-focused treatment option for diabetes.

What evidence suggests that this CGM Device is effective for diabetes?

Research shows that continuous glucose monitoring (CGM) devices can significantly aid people with type 2 diabetes in managing their blood sugar levels. In this trial, participants will use CGM devices along with a diet rich in fruits and vegetables. Studies have found that CGM can lower HbA1c levels, a measure of average blood sugar over time. CGM also reduces large fluctuations in blood sugar and increases the duration when blood sugar remains in a healthy range. Many users find that CGM enhances their understanding of diabetes, enabling more informed decisions about their care. These benefits can lead to improved overall diabetes management. ^{2 6 7 8 9}

Who Is on the Research Team?

David Kerr, PhD

Principal Investigator

Sutter Health

Are You a Good Fit for This Trial?

This trial is for Hispanic/Latino adults with Type 2 Diabetes not treated with insulin and an HbA1c level at or above 9%. The study focuses on the effects of a produce prescription program.

Inclusion Criteria

I agree to only use the study's CGM for tracking my glucose.

I am over 18 with type 2 diabetes and my last HbA1c test was 9% or higher.

Exclusion Criteria

Life expectancy less than 6 months

Any active clinically significant disease or disorder which in the investigator's opinion could interfere with participation in the study

I have Type 1 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a produce prescription program, with some randomized to also receive real-time continuous glucose monitoring (rtCGM) for 3 months

12 weeks

Follow-up

Participants are monitored for changes in HbA1c, body weight, waist circumference, blood pressure, and mental health using DASS-21

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CGM Device
• Salud Diabetes

Trial Overview The study tests how effective a lifestyle intervention, involving prescribed fruits and vegetables, is when combined with real-time continuous glucose monitoring (CGM) in managing diabetes.

How Is the Trial Designed?

Group I: Fruits and Vegetables Experimental Treatment 1 Intervention

Fruits, Vegetables only and CGM devices

Who Is Running the Clinical Trial?

Sutter Health

Lead Sponsor

Trials

26

Recruited

68,900+

William Marsh Rice University

Collaborator

Trials

50

Recruited

28,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10460137/

The Effectiveness of Continuous Glucose Monitoring ... The results of our study demonstrated that the adoption of CGM device leads to significant improvements in glycemic control, as evidenced by a ...

2. jmcp.org jmcp.org/doi/10.18553/jmcp.2024.30.10-b.s30

Using continuous glucose monitoring to measure and ... EFFICACY AND UTILITY OF CGM ... Other studies have demonstrated that CGM use significantly enhances users' understanding of their diabetes and ...

3. adces.org adces.org/education/danatech/glucose-monitoring/continuous-glucose-monitors-(cgm)/cgm-101/effectiveness-of-cgms

CGM l Effectiveness of CGMs l danatech Multiple research studies confirm the effectiveness of continuous glucose monitoring · Decreased HbA1C · Decreased glycemic variability · Increased time in range ...

4. diabetesjournals.org diabetesjournals.org/clinical/article/43/1/139/157329/Continuous-Glucose-Monitoring-in-Individuals-With

Continuous Glucose Monitoring in Individuals With Type 2 ... The use of CGM in the population of people with type 2 diabetes has been shown to improve patients' ability to use real-time glycemic ...

5. diabetes.org diabetes.org/advocacy/cgm-continuous-glucose-monitors

Continuous Glucose Monitoring (CGM) Real-time continuous glucose monitoring has led to tremendous outcomes for people with diabetes who, without a CGM, may have experienced potentially life- ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf12/P120005S018b.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) The purpose of this pivotal study was to evaluate the effectiveness and safety of the G4 CGM with a modified algorithm (Software 505) when used as an adjunctive ...

7. niddk.nih.gov niddk.nih.gov/health-information/diabetes/overview/managing-diabetes/continuous-glucose-monitoring

Continuous Glucose Monitoring - NIDDK CGM sensors estimate the glucose level in the fluid between your cells, which is very similar to the glucose level in your blood. Sensors must be replaced at ...

8. adces.org adces.org/education/danatech/glucose-monitoring/continuous-glucose-monitors-(cgm)/cgm-101/pros-cons-of-cgm

CGM l Pros and Cons of Continuous Glucose Monitors ... The ADA SOC 2025 recommends CGM for all individuals with Type 1 diabetes and those with Type 2 diabetes on insulin. It is also strongly recommended for pregnant ...

9. diabetesjournals.org diabetesjournals.org/care/article/47/1/169/154009/Efficacy-and-Safety-of-Continuous-Glucose

Efficacy and Safety of Continuous Glucose Monitoring and ... Both CGM and isCGM demonstrated a reduction in HbA 1c levels in individuals with T2D, and unlike CGM, isCGM use was associated with improved user satisfaction.