Diabetes Education With Real-time Continuous Glucose Monitoring

University of Washington120 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Diabetes Type 2

Interventions

Dexcom G6DEVICE

Dexcom G6 CGM device

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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 * 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

Locations (2)

University of Washington Diabetes Institute

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States

Outcomes

Primary Outcomes

Hemoglobin A1C

Percent change in A1C

Time frame: change at 12 weeks

Secondary Outcomes

CGM Mean Glucose

mean glucose at 12 weeks

Time frame: 12 weeks

CGM Percentage of Time in Range

percentage of time in range( tir)

Time frame: 12 WEEKS

Percent Change in BMI

percent change BMI ((kg/m2)

Time frame: change at 12 WEEKS

Blood Pressure Systolic

change in blood pressure

Time frame: change at 12 WEEKS

Physical Activity Questionnaire IPAQ

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

Time frame: 12 weeks

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

Time frame: baseline

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.