Salud Diabetes: A Pilot Study Comparing Lifestyle Interventions and Real-Time Continuous Glucose Monitoring
Recruiting · NCT06999356 · Interventional (participants receive a specific treatment) · Lead sponsor: Sutter Health
View the official record on ClinicalTrials.gov →Interventions studied
CGM Device
What this trial 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%.
Who can take part
Age range
18 Years to 89 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Sansum Clinic, Sutter Health - Santa Barbara, California, United States