Salud Diabetes: Comparing a produce prescription and real-time continuous glucose monitoring
Salud Diabetes: A Pilot Study Comparing Lifestyle Interventions and Real-Time Continuous Glucose Monitoring In Predominantly Hispanic/Latino Adults With Non-Insulin Treated Type 2 Diabetes And An HbA1c > 9%
This will test whether giving fresh produce, and adding a real-time continuous glucose monitor for people who don't improve, helps Hispanic/Latino adults with type 2 diabetes and an HbA1c of 9% or higher lower their blood sugar.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Sutter Health Academic / other |
| Locations | 1 site (Santa Barbara, California) |
| Trial ID | NCT06999356 on ClinicalTrials.gov |
What this trial studies
The program provides a produce prescription to predominantly Hispanic/Latino adults with established, non–insulin-treated type 2 diabetes and a recent HbA1c ≥9%. Participants who do not respond to the produce intervention are randomized to either continue the produce prescription alone or add real-time continuous glucose monitoring (rtCGM) for an additional three months. The study supplies the CGM device and requires participants to agree to track glucose only via the study-provided monitor. Key outcomes include changes in HbA1c, glucose patterns from rtCGM, and measures of diet and engagement.
Who should consider this trial
Good fit: Adults over 18 who identify as Hispanic/Latino with established type 2 diabetes not treated with insulin and a recent HbA1c ≥9% who can attend visits at the Santa Barbara site and agree to use the study CGM are the ideal candidates.
Not a fit: People with type 1 diabetes, current insulin use, pregnancy, use of steroids or other medications that affect glucose, stage 5 kidney disease, very limited life expectancy, or inability to follow study procedures are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could help people lower blood sugar and improve diet in a high-risk Hispanic/Latino population, potentially reducing diabetes-related complications.
How similar studies have performed: Produce prescription programs have shown improvements in fruit and vegetable intake and some cardiometabolic measures, and rtCGM has helped behavior change and glucose control in other populations, but combining these approaches in high-A1c, non–insulin-treated Hispanic/Latino adults is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Adults (aged\>18 years) with established T2D and HbA1c of 9% or higher per most recent test result within the last 6 months. Agreement to only track glucose levels via study-provided CGM - Exclusion Criteria: Type 1 diabetes, Insulin use, Pregnancy, Use of steroids or medications that impact glucose levels Medications Include: Atypical antipsychotics Clozapine Olanzapine Paliperidone Quietiapine Risperidone Corticosteroids Calcineurin inhibitors Cyclosporine Sirolimus Tacrolimus Protease Inhibitors Atazanavir Darunavir Fosamprenavir Indinavir Nelfinavir Ritonivir Saquinavir Tipranivir Life expectancy less than 6 months Diagnosis of stage 5 kidney disease or at risk of needing dialysis per Investigator discretion Any active clinically significant disease or disorder which in the investigator's opinion could interfere with participation in the study. Inability to follow study procedures per Investigator discretion \-
Where this trial is running
Santa Barbara, California
- Sansum Clinic, Sutter Health — Santa Barbara, California, United States (Recruiting)
Study contacts
- Principal investigator: David Kerr, PhD — Sutter Health
- Study coordinator: David Kerr, PhD
- Email: David.Kerr@sutterhelath.org
- Phone: 805-624-8688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.