Diabetes Education With Real-time Continuous Glucose Monitoring (CUTDM)

Study of a Culturally Tailored Diabetes Education Curriculum With Real-time Continuous Glucose Monitoring in a Latinx Population With Type 2 Diabetes (The CUTDM With CGM Study)

Determine the impact of the Compañeros en Salud (Partners in Health) curriculum in conjunction with RT-CGM on glycemic control in Latinx patients with T2D. Participants will be randomized to receive the Companeros en Salud diabetes self-management education and support (DSMES) intervention with or without RT-CGM

Study Overview

• Status: Completed
• Conditions: Diabetes Type 2
• Intervention / Treatment: Device: Dexcom G6

Detailed Description

The prevalence of type 2 diabetes is increasing especially in the Latinx community and in family members of those already living with diabetes. Diabetes education is a cornerstone of treatment but is often not culturally tailored and there is limited data on benefit of virtual delivery of sessions. Real Time Continuous glucose monitoring is a tool to improve diabetes but is not readily available to those living with type 2 diabetes not on multiple doses of insulin. Furthermore here is little to no data on RT-CGM use in different minority populations. Data is also lacking on if diabetes education for an individual affects the family unit. We hypothesize that culturally tailored Diabetes self-management education using and support (DSMES) using a team approach of health educators and Community health workers will improve glycemic indices. We further hypothesis that RT-CGM coupled to DSMES will enhances glycemic benefit and change nutrition and activity behaviors. This will be a randomized control trial of 100 Latinx participants who will all receive culturally tailored DSMES with or without cycle RT-CGM over 12 weeks. Primary outcome will be mean A1C improvement at 12 and 24 weeks based on attendance of sessions and RT-CGM use. Secondary outcomes will be satisfaction with education and CGM, changes in weight, blood pressure and self-reported nutrition and exercise changes. This study will be the first study to examine how DSMES with and without RT-CGM use improves health outcomes in the Latinx population and their families

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington
    • Seattle, Washington, United States, 98109
      • University of Washington Diabetes Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants adults 18-60 years old
2. Self-identify as Latinx
3. Have had a clinical diagnosis of T2D within the last 15 years with or without medication use
4. Have an A1C ≥8.0% at screening
5. Own or have routine access to a personal device that allows attending educational sessions virtually
6. Be physically and cognitively able to use the home CGM monitoring device
7. Be willing and able to follow all other study procedures

Exclusion Criteria

• Exclusion Criteria.

  1. Duration of diabetes >15 years
  2. Type 1 diabetes or latent autoimmune diabetes
  3. Current use of prandial insulin
  4. Any condition that prevents walking at least 1 city block
  5. History of serious mental illness other than adequately treated depression
  6. History of bariatric surgery or current participation in a weight management program
  7. Current diagnosis of cancer or other serious or systemic medical condition
  8. Significant active cardio- or cerebrovascular disease after review by PI
  9. Pregnancy
  10. know history x of of hypoglycemia unawareness
  11. Unable to read, understand, and sign the Informed Consent Form (ICF) and if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), communicate with the investigator, and understand and comply with protocol requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CGM with DM education; if you are in the intervention group you will received culturally tailored diabetes education and use a Real Time CGM device to see your glucose over 12 weeks. Both group will completed blinded CGM at the beginning of the study and at 24 weeks	Device: Dexcom G6; Dexcom G6 CGM device; Other Names: Compañeros en Salud (Partners in Health) curriculum
No Intervention: Education only; If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1C	Percent change in A1C	change at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM Mean Glucose	mean glucose at 12 weeks	12 weeks
CGM Percentage of Time in Range	percentage of time in range( tir)	12 WEEKS
Percent Change in BMI	percent change BMI ((kg/m2)	change at 12 WEEKS
Blood Pressure Systolic	change in blood pressure	change at 12 WEEKS
Physical Activity Questionnaire IPAQ	increase or decrease in days of vigorous activity - one question in IPAQ.	12 weeks
International Physical Activity Prevalence Study SELF-ADMINISTERED ENVIRONMENTAL MODULE(PANES):	Question Neighborhood Questionnaire/Neighborhood Safety questions 1 1. In general, how do you feel about your neighborhood? Do you feel it's a very bad, a fairly bad, a fairly good, or a very good place to live? reported number that felt it was very bad or fairly bad	baseline
PHQ9 Depression Score- Those With PHQ9>15	Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression.	12 weeks
PAID-5 Problem Areas in Diabetes Those With Score > 8	the scale gives a total score from 0 to 20. A score of 8 and above indicates a high level of diabetes-related distress	score at 12 weeks
Self-care for Diabetes (SDSCA) Number of Days Reporting Self Care	The Summary of Diabetes Self-Care Activities asks patient about diabetes self-care activities during the past 7 days and for each activity they can answer 0 days out of the week to a max of 7 days out of the week with higher score indicating more days doing this self -care activity and positive results	composite score at 12 weeks
Modified Joslin Diabetes Center CGM Experience	Experiences of CGM @Joslin 2009 scale range from 5 (strongly agree) to 1 ( strongly disagree) statements/questions that measured the amount of satisfaction that was derived from use of continuous glucose monitoring. Higher score meant perceived benefit/ better outcome	12 weeks
Perception of Behavior Modification After Real-Time- CGM Use	Did use of Real-Time- cgm in intervention group contribute to a healthier lifestyle ? yes	at 12 weeks
Household/Family Member Perception of Lifestyle Changes	household members perception of lifestyle changes after family member participated in education with CGM. Overall, do you feel Continuous Glucose Monitoring contributed to your making changes for a healthier lifestyle? yes	12 weeks
Pedometer	average number of steps per day	at 12 weeks
Self-Efficacy for Diabetes	the scale is 1-10 and the score is the mean of the eight items. If more than two items are missing, do not score the scale. Higher number indicates higher self-efficacy	score at 12 weeks
Food Insecurity Short Form 6 Question Composite With Score Reported as a Composite: High or Marginal Food Security, Low Food Security, Very Low Food Security	number of participants that had high or marginal food security based on 6 questions (geared to assess access or lack of access to food) composite score	baseline

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Washington State University; American Diabetes Association; DexCom, Inc.; Sea Mar Community Health Centers

Publications and helpful links

General Publications

• Ehrhardt N, Cedeno B, Montour L, Sinclair K, Ferguson G, Berberian P, Comstock B, Wright L. 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Actual): July 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: continuous glucose monitoring; diabetes education
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: STUDY00014396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No