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

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%

Overview

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.

Interventions

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

Primary outcome measures

• Change in HbA1c at 18 weeks compared to baseline [Time frame: 18 weeks]

Secondary outcome measures (5)

• Change in Body Weight [Time frame: 6 weeks and 3 months]
• Waist Circumference [Time frame: 6 weeks and 3 months]
• Blood Pressure [Time frame: 6 weeks and 3 months]
• Depression and anxiety are measured using DASS-21 (Depression Anxiety Stress Scale - 21) [Time frame: 6 weeks and 3 months]
• Height [Time frame: 6 weeks and 3 months.]

Eligibility criteria

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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• Sansum Clinic, Sutter Health — Santa Barbara

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 C PMID 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. PMID 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. PMID 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. PMID 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 Di PMID 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. PMID 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. PMID 31289781

Identifiers

NCT: NCT06999356 · 2024.099EXP · CMI-IIS-018

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗