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

Trial Summary

What is the purpose of this trial?

The aim of this proposal is to determine the impact of a produce prescription program in predominantly Hispanic/Latino adults with established non-insulin treated T2D and an HbA1c at or above 9%.

Research Team

David Kerr, PhD

Principal Investigator

Sutter Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+