Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-31 @ 5:58 PM
Study NCT ID:
NCT06999356
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2025-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salud Diabetes: A Pilot Study Comparing Lifestyle Interventions and Real-Time Continuous Glucose Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-05-12', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c at 18 weeks compared to baseline', 'timeFrame': '18 weeks', 'description': 'Change in HbA1c at 18 weeks compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Change in Body Weight', 'timeFrame': '6 weeks and 3 months', 'description': 'Weight will be measured in kg.'}, {'measure': 'Waist Circumference', 'timeFrame': '6 weeks and 3 months', 'description': 'Waist Circumference will be measure in cm'}, {'measure': 'Blood Pressure', 'timeFrame': '6 weeks and 3 months', 'description': 'Blood pressure will be measure in mm Hg.'}, {'measure': 'Depression and anxiety are measured using DASS-21 (Depression Anxiety Stress Scale - 21)', 'timeFrame': '6 weeks and 3 months', 'description': '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.\n\nThe questionnaire uses a Likert scale (0-3) where higher scores indicate greater symptom severity.\n\nScoring: 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.\n\nInterpretation: Higher scores on each subscale indicate a higher level of the corresponding variable.'}, {'measure': 'Height', 'timeFrame': '6 weeks and 3 months.', 'description': 'Height will be measure in inches.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Type 2 Diabetes', 'Diabetes', 'Nutrition', 'Vegetables', 'Fruits'], 'conditions': ['Diabetes', 'Nutrition']}, 'referencesModule': {'references': [{'pmid': '34167953', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16004657', 'type': 'BACKGROUND', 'citation': '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': '33521534', 'type': 'BACKGROUND', 'citation': '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': '36053813', 'type': 'BACKGROUND', 'citation': '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': '32518063', 'type': 'BACKGROUND', 'citation': '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': '22100963', 'type': 'BACKGROUND', 'citation': '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': '31289781', 'type': 'BACKGROUND', 'citation': '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': '36148880', 'type': 'BACKGROUND', 'citation': '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': '36507650', 'type': 'BACKGROUND', 'citation': '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': '32857648', 'type': 'BACKGROUND', 'citation': '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': '31177185', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}]}, 'descriptionModule': {'briefSummary': '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%.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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.\n\nAgreement to only track glucose levels via study-provided CGM -\n\nExclusion Criteria: Type 1 diabetes, Insulin use, Pregnancy, Use of steroids or medications that impact glucose levels\n\nMedications Include:\n\nAtypical antipsychotics Clozapine Olanzapine Paliperidone Quietiapine Risperidone Corticosteroids Calcineurin inhibitors Cyclosporine Sirolimus Tacrolimus Protease Inhibitors Atazanavir Darunavir Fosamprenavir Indinavir Nelfinavir Ritonivir Saquinavir Tipranivir\n\nLife 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.\n\nInability to follow study procedures per Investigator discretion\n\n\\-"}, 'identificationModule': {'nctId': 'NCT06999356', 'acronym': 'Salud Diabetes', 'briefTitle': 'Salud Diabetes: A Pilot Study Comparing Lifestyle Interventions and Real-Time Continuous Glucose Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Sutter Health'}, 'officialTitle': '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%', 'orgStudyIdInfo': {'id': '2024.099EXP'}, 'secondaryIdInfos': [{'id': 'CMI-IIS-018', 'type': 'OTHER_GRANT', 'domain': 'Abbott'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fruits and Vegetables', 'description': 'Fruits, Vegetables only and CGM devices', 'interventionNames': ['Device: CGM Device']}], 'interventions': [{'name': 'CGM Device', 'type': 'DEVICE', 'description': 'Fruits and Vegetables and some groups will get CGM devices along with Fruits and Vegetables', 'armGroupLabels': ['Fruits and Vegetables']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93110', 'city': 'Santa Barbara', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Morgon Caldwell-Holden', 'role': 'CONTACT', 'email': 'Morgan.Caldwell-Holden@sutterhealth.org', 'phone': '805-879-5093', 'phoneExt': '8405'}], 'facility': 'Sansum Clinic, Sutter Health', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}], 'centralContacts': [{'name': 'David Kerr, PhD', 'role': 'CONTACT', 'email': 'David.Kerr@sutterhelath.org', 'phone': '805-624-8688'}, {'name': 'Brett Avery', 'role': 'CONTACT', 'email': 'Brett.Avery@sutterhealth.org', 'phone': '408-838-0016'}], 'overallOfficials': [{'name': 'David Kerr, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sutter Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF'], 'timeFrame': 'May 2025', 'ipdSharing': 'YES', 'description': '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', 'accessCriteria': 'Study team at Rice University'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sutter Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'William Marsh Rice University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}