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NCT Number: NCT06999356

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

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%.

Recruiting

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sansum Clinic, Sutter Health

Santa Barbara, California, 93110, United States

Location status: Recruiting

Location contact

Morgon Caldwell-Holden

CONTACT

[email protected]

805-879-5093 ext. 8405

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

CGM Device

Device

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

Primary outcomes

  1. Change in HbA1c at 18 weeks compared to baseline

    Time frame: 18 weeks

    Change in HbA1c at 18 weeks compared to baseline

Secondary outcomes

  1. Change in Body Weight

    Time frame: 6 weeks and 3 months

    Weight will be measured in kg.

  2. Waist Circumference

    Time frame: 6 weeks and 3 months

    Waist Circumference will be measure in cm

  3. Blood Pressure

    Time frame: 6 weeks and 3 months

    Blood pressure will be measure in mm Hg.

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

    Time frame: 6 weeks and 3 months

    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.

  5. Height

    Time frame: 6 weeks and 3 months.

    Height will be measure in inches.

Study contacts

Contact information is provided by the study sponsor or research team.

Brett Avery

CONTACT

[email protected]

408-838-0016

David Kerr, PhD

CONTACT

[email protected]

805-624-8688

Sponsors and collaborators

Lead sponsor

Sutter Health

Other

Collaborators

  • William Marsh Rice University

Registry information

Official study 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%

Acronym: Salud Diabetes

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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