Salud Diabetes: A Pilot Study Comparing Lifestyle Interventions and Real-Time Continuous Glucose Monitoring
NCT ID: NCT06999356
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2025-05-22
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Fruits and Vegetables
Fruits, Vegetables only and CGM devices
CGM Device
Fruits and Vegetables and some groups will get CGM devices along with Fruits and Vegetables
Interventions
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CGM Device
Fruits and Vegetables and some groups will get CGM devices along with Fruits and Vegetables
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
\-
18 Years
89 Years
ALL
No
Sponsors
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William Marsh Rice University
OTHER
Sutter Health
OTHER
Responsible Party
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Principal Investigators
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David Kerr, PhD
Role: PRINCIPAL_INVESTIGATOR
Sutter Health
Locations
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Sansum Clinic, Sutter Health
Santa Barbara, California, United States
Countries
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Central Contacts
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Facility Contacts
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Morgon Caldwell-Holden
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Other Identifiers
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CMI-IIS-018
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024.099EXP
Identifier Type: -
Identifier Source: org_study_id