Status:
COMPLETED
Diabetes Education With Real-time Continuous Glucose Monitoring
Lead Sponsor:
University of Washington
Collaborating Sponsors:
American Diabetes Association
Washington State University
Conditions:
Diabetes Type 2
Eligibility:
All Genders
18-60 years
Phase:
NA
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 t...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05394844
Start Date
November 11 2022
End Date
November 30 2024
Last Update
December 1 2025
Active Locations (2)
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1
University of Washington Diabetes Institute
Seattle, Washington, United States, 98109
2
University of Washington
Seattle, Washington, United States, 98109