Effectiveness of a culturally tailored diabetes education curriculum with real-time continuous glucose monitoring in a Latinx population with type 2 diabetes: the CUT-DM with CGM for Latinx randomised controlled trial study protocol

Nicole Ehrhardt; Brian Cedeno; Laura Montour; Ka'imi Sinclair; Gary Ferguson; Peter Berberian; Bryan Comstock; Lorena Wright

doi:10.1136/bmjopen-2023-082005

Effectiveness of a culturally tailored diabetes education curriculum with real-time continuous glucose monitoring in a Latinx population with type 2 diabetes: the CUT-DM with CGM for Latinx randomised controlled trial study protocol

BMJ Open. 2023 Dec 28;13(12):e082005. doi: 10.1136/bmjopen-2023-082005.

Authors

Nicole Ehrhardt¹, Brian Cedeno², Laura Montour³, Ka'imi Sinclair⁴, Gary Ferguson⁵, Peter Berberian⁶, Bryan Comstock⁷, Lorena Wright⁸

Affiliations

¹ UW Medicine Diabetes Institute, Seattle, Washington, USA nehrhard@uw.edu.
² University of Washington School of Medicine, Seattle, Washington, USA.
³ Department of Family Medicine, University of Washington, Seattle, Washington, USA.
⁴ Washington State University - Spokane, Seattle, Washington, USA.
⁵ Washington State University, Pullman, Washington, USA.
⁶ Sea Mar Community Health Centers, Seattle, Washington, USA.
⁷ Department of Biostatistics, University of Washington, Seattle, Washington, USA.
⁸ Medicine, University of Washington, Seattle, Washington, USA.

Abstract

Introduction: The prevalence of type 2 diabetes (T2D) is increasing in the Latinx community. Despite telehealth and technology becoming more available, these resources are not reaching the Latinx population. Diabetes education is a cornerstone of treatment; however, access to culturally tailored content is a barrier to the Latinx population. Real-time continuous glucose monitoring (RT-CGM) is a patient-empowering tool that can improve glycaemic control, but it is not readily available for Latinx patients with T2D. We aim to evaluate a culturally tailored diabetes self-management education and support (DSMES) curriculum, using a team-based approach to improve glycaemic control, promote healthy behaviours and enhance patient access with the use of telehealth in Latinx individuals. The primary aim of the study is to evaluate the additive effectiveness of RT-CGM on glycaemia and behavioural changes among Latinx patients undergoing a culturally tailored DSMES. A sub aim of the study is to evaluate family members' change in behaviours.

Methods: We propose a randomised controlled trial of blinded versus RT-CGM with 100 Latinx participants with T2D who will receive DSMES via telemedicine over 12 weeks (n=50 per group). The study will be conducted at a single large federally qualified health centre system. The control group will receive culturally tailored DSMES and blinded CGM. The intervention group will receive DSMES and RT-CGM. The DSMES is conducted by community health educators weekly over 12 weeks in Spanish or English, based on participant's language preference. Patients in the RT-CGM group will have cyclical use with a goal of 50 days wear time. The primary outcomes are changes in haemoglobin A1c and CGM-derived metrics at 3 and 6 months. The secondary outcomes include participants' self-management knowledge and behaviour and household members' change in lifestyle.

Ethics and dissemination: The study proposal was approved by the University of Washington ethics/institutional review board (IRB) Committee as minimal risk (IRB ID: STUDY00014396) and the Sea Mar IRB committee.

Trial registration number: ClinicalTrials.gov identifier: NCT05394844.

Keywords: DIABETES & ENDOCRINOLOGY; GENERAL MEDICINE (see Internal Medicine); Health Equity.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Blood Glucose
Blood Glucose Self-Monitoring*
Continuous Glucose Monitoring
Curriculum
Diabetes Mellitus, Type 2* / therapy
Hispanic or Latino
Humans
Randomized Controlled Trials as Topic

Substances

Blood Glucose

Associated data

ClinicalTrials.gov/NCT05394844