NCT06999356 · Sutter Health
Salud Diabetes: A Pilot Study Comparing Lifestyle Interventions and Real-Time Continuous Glucose Monitoring
(Salud Diabetes)
What this study is about
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%.
View original scientific description
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%.
Interventions
DEVICE
CGM Device
Fruits and Vegetables and some groups will get CGM devices along with Fruits and Vegetables
Primary outcome measures
Change in HbA1c at 18 weeks compared to baseline
Time frame: 18 weeks
Change in HbA1c at 18 weeks compared to baseline
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Santa Barbara, California
Collaborators
William Marsh Rice University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 31, 2025 · Source of record for eligibility and locations