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DiabetesSalud DiabetesNCT06999356

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

A study testing CGM Device in people with Diabetes and Nutrition, run by Sutter Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Diabetes, Nutrition
What is being tested?
CGM Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
22 May 2025to 2 Oct 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

-

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sansum Clinic, Sutter Health

    Santa Barbara, California, 93110

Other trials in United States

About this study

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%

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%.

Read the 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.

Conditions
Diabetes, Nutrition
Being tested
CGM Device
Keywords
Type 2 Diabetes, Diabetes, Nutrition, Vegetables, Fruits
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CGM DeviceDevice

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

Study groups in NCT06999356
Study groupRoleWhat they receive
Fruits and VegetablesOtherFruits, Vegetables only and CGM devices
Receives: Device: CGM Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c at 18 weeks compared to baseline

    Change in HbA1c at 18 weeks compared to baseline

    Measured: 18 weeks

Secondary outcomes (5)

  1. Change in Body Weight

    Weight will be measured in kg.

    Measured: 6 weeks and 3 months

  2. Waist Circumference

    Waist Circumference will be measure in cm

    Measured: 6 weeks and 3 months

  3. Blood Pressure

    Blood pressure will be measure in mm Hg.

    Measured: 6 weeks and 3 months

  4. 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.

    Measured: 6 weeks and 3 months

  5. Height

    Height will be measure in inches.

    Measured: 6 weeks and 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2025
  2. Study start22 May 2025
  3. Primary completion8 Jul 2026
  4. Study completion2 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06999356
Sponsor's protocol ID
2024.099EXP
Other IDs
CMI-IIS-018
Acronym
Salud Diabetes
Status last verified
Oct 2026
First submitted
12 May 2025
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: A Limited Data set will be shared with the study team at Rice University for analysis of CGM data, demographics, and self-reported data. Direct identified will be removed but dates will be included

Publications

  • Hernandez-Jimenez S, Garcia-Ulloa AC, Anaya P, Gasca-Pineda R, Sanchez-Trujillo LA, Pena Baca H, Gonzalez-Pier E, Graue-Hernandez EO, Aguilar-Salinas CA, Gomez-Perez FJ, Kershenobich-Stalnikowitz D; Group of Study CAIPaDi. Cost-effectiveness of a self-management and comprehensive training intervention in patients with type 2 diabetes up to 5 years of diagnosis in a specialized hospital in Mexico City. BMJ Open Diabetes Res Care. 2021 Jun;9(1):e002097. doi: 10.1136/bmjdrc-2020-002097.

    PubMed 34167953

  • Aiken M, Villa P, Lamotte M, Tewary V, Ramos M. Advancing glycemic management in people with diabetes; new approaches and measures. IQVIA Institute for Human Data Science Nov 2019. https://www.iqvia.com/insights/the-iqvia-institute/reports/advancing-glycemic-management-in-people-with-diabetes.

  • Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.

    PubMed 16004657

  • Kerr D, Barua S, Glantz N, Conneely C, Kujan M, Bevier W, Larez A, Sabharwal A. Farming for life: impact of medical prescriptions for fresh vegetables on cardiometabolic health for adults with or at risk of type 2 diabetes in a predominantly Mexican-American population. BMJ Nutr Prev Health. 2020 Oct 5;3(2):239-246. doi: 10.1136/bmjnph-2020-000133. eCollection 2020 Dec.

    PubMed 33521534

  • Moon SJ, Kim KS, Lee WJ, Lee MY, Vigersky R, Park CY. Efficacy of intermittent short-term use of a real-time continuous glucose monitoring system in non-insulin-treated patients with type 2 diabetes: A randomized controlled trial. Diabetes Obes Metab. 2023 Jan;25(1):110-120. doi: 10.1111/dom.14852. Epub 2022 Sep 23.

    PubMed 36053813

  • Wada E, Onoue T, Kobayashi T, Handa T, Hayase A, Ito M, Furukawa M, Okuji T, Okada N, Iwama S, Sugiyama M, Tsunekawa T, Takagi H, Hagiwara D, Ito Y, Suga H, Banno R, Kuwatsuka Y, Ando M, Goto M, Arima H. Flash glucose monitoring helps achieve better glycemic control than conventional self-monitoring of blood glucose in non-insulin-treated type 2 diabetes: a randomized controlled trial. BMJ Open Diabetes Res Care. 2020 Jun;8(1):e001115. doi: 10.1136/bmjdrc-2019-001115.

    PubMed 32518063

  • Vigersky RA, Fonda SJ, Chellappa M, Walker MS, Ehrhardt NM. Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes. Diabetes Care. 2012 Jan;35(1):32-8. doi: 10.2337/dc11-1438. Epub 2011 Nov 18.

    PubMed 22100963

  • Glantz NM, Duncan I, Ahmed T, Fan L, Reed BL, Kalirai S, Kerr D. Racial and Ethnic Disparities in the Burden and Cost of Diabetes for US Medicare Beneficiaries. Health Equity. 2019 May 15;3(1):211-218. doi: 10.1089/heq.2019.0004. eCollection 2019.

    PubMed 31289781

  • Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, Rosas SE, Del Prato S, Mathieu C, Mingrone G, Rossing P, Tankova T, Tsapas A, Buse JB. Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022 Nov 1;45(11):2753-2786. doi: 10.2337/dci22-0034.

    PubMed 36148880

  • ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S140-S157. doi: 10.2337/dc23-S009.

    PubMed 36507650

  • Pednekar P, Heller DA, Peterson AM. Association of Medication Adherence with Hospital Utilization and Costs Among Elderly with Diabetes Enrolled in a State Pharmaceutical Assistance Program. J Manag Care Spec Pharm. 2020 Sep;26(9):1099-1108. doi: 10.18553/jmcp.2020.26.9.1099.

    PubMed 32857648

  • Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.

    PubMed 31177185

  • Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014 (1st ed.). 2014. Atlanta, GA: Department of Health and Human Services; Available at https://cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf

Questions about this trial

What is this clinical trial studying?

A study testing CGM Device in people with Diabetes and Nutrition, run by Sutter Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c at 18 weeks compared to baseline (time frame: 18 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06999356, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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