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

Sutter Health200 enrolled

Overview

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%.

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 Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

200

Conditions

Diabetes Nutrition

Interventions

CGM DeviceDEVICE

Fruits and Vegetables and some groups will get CGM devices along with Fruits and Vegetables

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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 \-

Locations (1)

Sansum Clinic, Sutter Health

Santa Barbara, California, United States

RECRUITING

Outcomes

Primary Outcomes

Change in HbA1c at 18 weeks compared to baseline

Time frame: 18 weeks

Secondary Outcomes

Change in Body Weight

Weight will be measured in kg.

Time frame: 6 weeks and 3 months

Waist Circumference

Waist Circumference will be measure in cm

Time frame: 6 weeks and 3 months

Blood Pressure

Blood pressure will be measure in mm Hg.

Time frame: 6 weeks and 3 months

Depression and anxiety are measured using DASS-21 (Depression Anxiety Stress Scale - 21)

For the scales, the DASS-21 (Depression Anxiety Stress Scale - 21) reports on depression, anxiety, and stress by using a self-report questionnaire with 21 items. It consists of three subscales, each with seven items, assessing the frequency and severity of symptoms related to each emotion. The questionnaire uses a Likert scale (0-3) where higher scores indicate greater symptom severity. Scoring: Each subscale (Depression, Anxiety, and Stress) is scored separately by summing the responses to its respective items. The total score for each subscale can range from 0 to 21. Interpretation: Higher scores on each subscale indicate a higher level of the corresponding variable.

Time frame: 6 weeks and 3 months

Height

Height will be measure in inches.

Time frame: 6 weeks and 3 months.

Central Contacts

David Kerr, PhD

CONTACT

805-624-8688 David.Kerr@sutterhelath.org

Brett Avery

CONTACT

408-838-0016 Brett.Avery@sutterhealth.org

Data from ClinicalTrials.gov

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