Clinical trial NCT06999356: Salud Diabetes: A Pilot Study Comparing Lifestyle Interventions and Real-Time Continuous Glucose Monitoring
Official title: 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%
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Nutrition
Keywords: Type 2 Diabetes
Diabetes
Nutrition
Vegetables
Fruits
Lead sponsor: Sutter Health
Sponsor class: OTHER
Collaborators: name: William Marsh Rice University
First posted: 2025-05-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

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Primary outcomes:
measure: Change in HbA1c at 18 weeks compared to baseline
timeFrame: 18 weeks
Secondary outcomes:
measure: Change in Body Weight
timeFrame: 6 weeks and 3 months
measure: Waist Circumference
timeFrame: 6 weeks and 3 months
measure: Blood Pressure
timeFrame: 6 weeks and 3 months
measure: Depression and anxiety are measured using DASS-21 (Depression Anxiety Stress Scale - 21)
timeFrame: 6 weeks and 3 months
measure: Height
timeFrame: 6 weeks and 3 months.
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sansum Clinic, Sutter Health
state: California
Study officials:
affiliation: Sutter Health
name: David Kerr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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