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Completed

NCT Number: NCT05394844

Diabetes Education With Real-time Continuous Glucose Monitoring

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington, Seattle, Washington, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Exclusion Criteria.
  • Duration of diabetes >15 years
  • Type 1 diabetes or latent autoimmune diabetes
  • Current use of prandial insulin
  • Any condition that prevents walking at least 1 city block
  • History of serious mental illness other than adequately treated depression
  • History of bariatric surgery or current participation in a weight management program
  • Current diagnosis of cancer or other serious or systemic medical condition
  • Significant active cardio- or cerebrovascular disease after review by PI
  • Pregnancy
  • know history x of of hypoglycemia unawareness
  • 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

Treatment and study plan

Dexcom G6

Device

Dexcom G6 CGM device

Other names: Compañeros en Salud (Partners in Health) curriculum

Primary outcomes

  1. Hemoglobin A1C

    Time frame: change at 12 weeks

    Percent change in A1C

Secondary outcomes

  1. CGM Mean Glucose

    Time frame: 12 weeks

    mean glucose at 12 weeks

  2. CGM Percentage of Time in Range

    Time frame: 12 WEEKS

    percentage of time in range( tir)

  3. Percent Change in BMI

    Time frame: change at 12 WEEKS

    percent change BMI ((kg/m2)

  4. Blood Pressure Systolic

    Time frame: change at 12 WEEKS

    change in blood pressure

  5. Physical Activity Questionnaire IPAQ

    Time frame: 12 weeks

    increase or decrease in days of vigorous activity - one question in IPAQ.

  6. International Physical Activity Prevalence Study SELF-ADMINISTERED ENVIRONMENTAL MODULE(PANES):

    Time frame: baseline

    Question Neighborhood Questionnaire/Neighborhood Safety questions 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

  7. PHQ9 Depression Score- Those With PHQ9>15

    Time frame: 12 weeks

    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.

  8. PAID-5 Problem Areas in Diabetes Those With Score > 8

    Time frame: score at 12 weeks

    the scale gives a total score from 0 to 20. A score of 8 and above indicates a high level of diabetes-related distress

  9. Self-care for Diabetes (SDSCA) Number of Days Reporting Self Care

    Time frame: composite score at 12 weeks

    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

  10. Modified Joslin Diabetes Center CGM Experience

    Time frame: 12 weeks

    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

  11. Perception of Behavior Modification After Real-Time- CGM Use

    Time frame: at 12 weeks

    Did use of Real-Time- cgm in intervention group contribute to a healthier lifestyle ? yes

  12. Household/Family Member Perception of Lifestyle Changes

    Time frame: 12 weeks

    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

  13. Pedometer

    Time frame: at 12 weeks

    average number of steps per day

  14. Self-Efficacy for Diabetes

    Time frame: score at 12 weeks

    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

  15. 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

    Time frame: baseline

    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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • American Diabetes Association
  • DexCom, Inc.
  • Sea Mar Community Health Centers
  • Washington State University

Registry information

Official study title

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)

Acronym: CUTDM

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 27, 2022
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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