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%
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sutter Health
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in HbA1c at 18 weeks compared to baseline
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Fruits and Vegetables
Fruits, Vegetables only and CGM devices
Intervention: CGM Device (Device)
Outcomes
Primary Outcomes
Change in HbA1c at 18 weeks compared to baseline
Time Frame: 18 weeks
Change in HbA1c at 18 weeks compared to baseline
Secondary Outcomes
- Change in Body Weight(6 weeks and 3 months)
- Waist Circumference(6 weeks and 3 months)
- Blood Pressure(6 weeks and 3 months)
- Height(6 weeks and 3 months.)
- Depression and anxiety are measured using DASS-21 (Depression Anxiety Stress Scale - 21)(6 weeks and 3 months)