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

NCT06999356 | Recruiting FDA Device

• 2 other identifiers: 2024.099EXPCMI-IIS-018
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Type 2 Diabetes; Diabetes; Nutrition; Vegetables; Fruits

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c at 18 weeks compared to baseline

  Change in HbA1c at 18 weeks compared to baseline

  18 weeks

Secondary Outcomes (5)

• Change in Body Weight

  6 weeks and 3 months

• Waist Circumference

  6 weeks and 3 months

• Blood Pressure

  6 weeks and 3 months

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

  6 weeks and 3 months

• Height

  6 weeks and 3 months.

Study Arms (1)

Fruits and Vegetables

OTHER

Fruits, Vegetables only and CGM devices

Device: CGM Device

Interventions

CGM Device DEVICE

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

Fruits and Vegetables

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agreement to only track glucose levels via study-provided CGM -

You may not qualify if:

• 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

Sponsors & Collaborators

• Sutter Health: lead
• William Marsh Rice University: collaborator

Study Sites (1)

Sansum Clinic, Sutter Health

Santa Barbara, California, 93110, United States

RECRUITING

Related Publications (13)

• 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.

  PMID: 34167953 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 16004657 BACKGROUND

• 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.

  PMID: 33521534 BACKGROUND

• 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.

  PMID: 36053813 BACKGROUND

• 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.

  PMID: 32518063 BACKGROUND

• 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.

  PMID: 22100963 BACKGROUND

• 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.

  PMID: 31289781 BACKGROUND

• 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.

  PMID: 36148880 BACKGROUND

• 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.

  PMID: 36507650 BACKGROUND

• 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.

  PMID: 32857648 BACKGROUND

• 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.

  PMID: 31177185 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• David Kerr, PhD

  Sutter Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Kerr, PhD

CONTACT

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

Brett Avery

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 31, 2025
• Study Start: May 22, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: May 2025
• Access Criteria: Study team at Rice University

Locations

US (1)