Diabetes Education With Real-time Continuous Glucose Monitoring

NCT ID: NCT05394844

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2024-11-30

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Dexcom G6

Intervention Type: DEVICE

Dexcom G6 CGM device

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dexcom G6

Dexcom G6 CGM device

Intervention Type: DEVICE

Other Intervention Names

Compañeros en Salud (Partners in Health) curriculum

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

Washington State University

OTHER

Sponsor Role: collaborator

Sea Mar Community Health Centers

OTHER

Sponsor Role: collaborator

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Nicole Ehrhardt

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Washington Diabetes Institute

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38154895 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00014396

Identifier Type: -

Identifier Source: org_study_id