Clinical trial NCT05394844: Diabetes Education With Real-time Continuous Glucose Monitoring
Official title: Study of a Culturally Tailored Diabetes Education Curriculum With Real-time Continuous Glucose Monitoring in a Latinx Population With Type 2 Diabetes (The CUTDM With CGM Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Type 2
Keywords: continuous glucose monitoring
diabetes education
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
name: Washington State University
name: Sea Mar Community Health Centers
name: DexCom, Inc.
First posted: 2022-05-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Real Time Continuous Glucose Monitoring using Dexcom G6 and Diabetes education
Primary purpose: TREATMENT

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

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

* 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

Primary outcomes:
measure: A1C
timeFrame: change at 12 and 24 weeks after education intervention
Secondary outcomes:
measure: CGM mean glucose
timeFrame: change at 12 and 24 weeks
measure: CGM percent time in range
timeFrame: change at 12 and 24 weeks
measure: BMI (kg/m2)
timeFrame: change at 12 and 24 weeks
measure: Blood pressure systolic and diastolic
timeFrame: change at 12 and 24 weeks
measure: physical activity questionnaire IPAQ
timeFrame: 12 and 24 weeks
measure: International Physical Activity Prevalence Study SELF-ADMINISTERED ENVIRONMENTAL MODULE(PANES):
timeFrame: baseline
measure: PHQ9 Depression score
timeFrame: baseline
measure: PAID-5 problem areas in diabetes
timeFrame: change at 12 and 24 weeks
measure: Self-care for diabetes (SDSCA)
timeFrame: change at 12 and 24 weeks
measure: modified joslin diabetes center CGM experience
timeFrame: 12 weeks
measure: perception of behavior modification after CGM use
timeFrame: 12 weeks
measure: household/family member perception of lifestyle changes
timeFrame: 12 weeks
measure: pedometer
timeFrame: change at 12 and 24 weeks
measure: The Neighborhood Questionnaire/Neighborhood Safety
timeFrame: baseline
measure: Self-Efficacy for Diabetes
timeFrame: change at 12 and 24 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Diabetes Institute
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: