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Diabetes Type 2CUTDMNCT05394844

Diabetes Education With Real-time Continuous Glucose Monitoring

A study testing Dexcom G6 in people with Diabetes Type 2, run by University of Washington at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Diabetes Type 2
What is being tested?
Dexcom G6
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesUnited States
Study dates
11 Nov 2022to 30 Nov 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Washington Diabetes Institute

    Seattle, Washington, 98109

  • University of Washington

    Seattle, Washington, 98109

Other trials in United States

About this study

Official 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)

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

Read the 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

Conditions
Diabetes Type 2
Being tested
Dexcom G6
Keywords
continuous glucose monitoring, diabetes education
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexcom G6Device

    Also called Compañeros en Salud (Partners in Health) curriculum

    Dexcom G6 CGM device

Study groups in NCT05394844
Study groupRoleWhat they receive
CGM with DM educationActive comparatorif 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
Receives: Device: Dexcom G6
Education onlyNo interventionIf 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin A1C

    Percent change in A1C

    Measured: change at 12 weeks

Secondary outcomes (15)

  1. CGM Mean Glucose

    mean glucose at 12 weeks

    Measured: 12 weeks

  2. CGM Percentage of Time in Range

    percentage of time in range( tir)

    Measured: 12 WEEKS

  3. Percent Change in BMI

    percent change BMI ((kg/m2)

    Measured: change at 12 WEEKS

  4. Blood Pressure Systolic

    change in blood pressure

    Measured: change at 12 WEEKS

  5. Physical Activity Questionnaire IPAQ

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

    Measured: 12 weeks

  6. 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

    Measured: baseline

  7. 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.

    Measured: 12 weeks

  8. 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

    Measured: score at 12 weeks

  9. 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

    Measured: composite score at 12 weeks

  10. 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

    Measured: 12 weeks

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

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

    Measured: at 12 weeks

  12. 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

    Measured: 12 weeks

  13. Pedometer

    average number of steps per day

    Measured: at 12 weeks

  14. 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

    Measured: score at 12 weeks

  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

    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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2022
  2. Study start11 Nov 2022
  3. Primary completion30 Jul 2024
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Real Time Continuous Glucose Monitoring using Dexcom G6 and Diabetes education
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05394844
Sponsor's protocol ID
STUDY00014396
Acronym
CUTDM
Status last verified
Nov 2025
First submitted
19 Apr 2022
Last updated
1 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 38154895

Questions about this trial

What is this clinical trial studying?

A study testing Dexcom G6 in people with Diabetes Type 2, run by University of Washington at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin A1C (time frame: change at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05394844, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.

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