Diabetes Education With Real-time Continuous Glucose Monitoring

NCT05394844 | Completed Results DMC FDA Device

• 1 other identifier: STUDY00014396
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Diabetes Type 2

Keywords

continuous glucose monitoring; diabetes education

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C

  Percent change in A1C

  change at 12 weeks

Secondary Outcomes (15)

• CGM Mean Glucose

  12 weeks

• CGM Percentage of Time in Range

  12 WEEKS

• Percent Change in BMI

  change at 12 WEEKS

• Blood Pressure Systolic

  change at 12 WEEKS

• Physical Activity Questionnaire IPAQ

  12 weeks

Study Arms (2)

CGM with DM education

ACTIVE COMPARATOR

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

Education only

NO INTERVENTION

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

Interventions

Dexcom G6 DEVICE

Dexcom G6 CGM device

Also known as: Compañeros en Salud (Partners in Health) curriculum

CGM with DM education

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

University of Washington Diabetes Institute

Seattle, Washington, 98109, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• 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.

  PMID: 38154895 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr nicole ehrhardt
• Organization: uwashington

nehrhard@uw.edu

2404479566

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Real Time Continuous Glucose Monitoring using Dexcom G6 and Diabetes education

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 27, 2022
• Study Start: November 11, 2022
• Primary Completion: July 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 1, 2025
• Results First Posted: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)