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NCT06999356NARecruiting

Salud Diabetes: A Pilot Study Comparing Lifestyle Interventions and Real-Time Continuous Glucose Monitoring

Sutter Health

Start Date

5/22/2025

Completion Date

5/1/2026

Summary

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%.

Detailed 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%. For individuals not responding to the produce prescription program, they will be randomized to the addition of real-time continuous glucose monitoring (rtCGM) or continue with the produce prescription program only for a further 3 months.

Eligibility Criteria

Age Range: 18 years to 89 years

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 \-

Interventions

DEVICE

CGM Device

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Conditions

DiabetesNutrition

Locations

Sansum Clinic, Sutter Health

Santa Barbara, California 93110

United States