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

Not Applicable

Recruiting

• Conditions: Diabetes; Nutrition

• Registration Number: NCT06999356
• Lead Sponsor: Sutter Health

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 Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-12
• Study Start: 2025-05-22
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in HbA1c at 18 weeks compared to baseline	18 weeks	Change in HbA1c at 18 weeks compared to baseline

Secondary Outcome Measures

Name	Time	Method
Depression and anxiety are measured using DASS-21 (Depression Anxiety Stress Scale - 21)	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.
Height	6 weeks and 3 months.	Height will be measure in inches.
Blood Pressure	6 weeks and 3 months	Blood pressure will be measure in mm Hg.
Change in Body Weight	6 weeks and 3 months	Weight will be measured in kg.
Waist Circumference	6 weeks and 3 months	Waist Circumference will be measure in cm

Trial Locations

Locations (1)

Sansum Clinic, Sutter Health; 🇺🇸 Santa Barbara, California, United States