Recruiting

Produce Prescription

Sponsor:

Sutter Health

Code:

NCT06999356

Conditions

Diabetes

Nutrition

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CGM Device

Study Details

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%.

Conditions

Diabetes

Nutrition

Study ID

NCT06999356

Start date

May 22, 2025

Status verified date

May, 2025

Completion date

May, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

-

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Fruits and Vegetables

Fruits, Vegetables only and CGM devices

Interventions

CGM Device

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

Primary outcome measure

  • Change in HbA1c at 18 weeks compared to baseline [ Time Frame: 18 weeks ]

Central Contacts and Locations

Locations

Sansum Clinic, Sutter Health

Recruiting

Santa Barbara, California, United States, 93110

Contacts

More Information

Sponsor

Sutter Health

Last update posted

May 31, 2025

Last verified

May, 2025

Keywords

  • Type 2 Diabetes
  • Diabetes
  • Nutrition
  • Vegetables
  • Fruits

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sutter Health on 2025-05-31.