Status
Conditions
Treatments
Study type
Funder types
Identifiers
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%.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and 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
Primary purpose
Allocation
Interventional model
Masking
200 participants in 1 patient group
Loading...
Central trial contact
Brett Avery; David Kerr, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal