N/A
N=120
Diabetes Education With Real-time Continuous Glucose Monitoring
Diabetes Type 2
Bottom Line
View on ClinicalTrials.gov: NCT05394844 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Hemoglobin A1C — -2.3; -1.5 percent change in A1C
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dexcom G6 (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1C |
-2.3; -1.5 | — |
| SECONDARY CGM Mean Glucose |
208.4; 239.6 | — |
| SECONDARY CGM Percentage of Time in Range |
13.2; 6.2 | — |
| SECONDARY Percent Change in BMI |
-1; -2.4 | — |
| SECONDARY Blood Pressure Systolic |
-2.5; -0.3 | — |
| SECONDARY Physical Activity Questionnaire IPAQ |
1; 0.14 | — |
| SECONDARY International Physical Activity Prevalence Study SELF-ADMINISTERED ENVIRONMENTAL MODULE(PANES): |
3; 9 | — |
| SECONDARY PHQ9 Depression Score- Those With PHQ9>15 |
5; 7 | — |
| SECONDARY PAID-5 Problem Areas in Diabetes Those With Score > 8 |
13; 11 | — |
| SECONDARY Self-care for Diabetes (SDSCA) Number of Days Reporting Self Care |
5.3; 3.3 | — |
| SECONDARY Modified Joslin Diabetes Center CGM Experience |
4.33 | — |
| SECONDARY Perception of Behavior Modification After Real-Time- CGM Use |
36 | — |
| SECONDARY Household/Family Member Perception of Lifestyle Changes |
13 | — |
| SECONDARY Pedometer |
6931; 4703 | — |
| SECONDARY Self-Efficacy for Diabetes |
8.5; 7.7 | — |
| SECONDARY 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 |
30; 37 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05394844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.