Diabetes Education With Real-time Continuous Glucose Monitoring

Not Applicable

Active, not recruiting

• Conditions: Diabetes Type 2
• Interventions: Device: Dexcom G6

• Registration Number: NCT05394844
• Lead Sponsor: University of Washington

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

Study Timeline

• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-27
• Study Start: 2022-11-11
• Primary Completion: 2024-04-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CGM with DM education	Dexcom G6	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

Primary Outcome Measures

Name	Time	Method
A1C	change at 12 and 24 weeks after education intervention	average glucose over 3 months

Secondary Outcome Measures

Name	Time	Method
Self-care for diabetes (SDSCA)	change at 12 and 24 weeks	. Responses are rated on a 5 point scale ranging from ''can't do at all'' to ''certain can do'' (1, 5). In this scale, higher scores indicate higher self-efficacy in perform- ing DSM activities.
modified joslin diabetes center CGM experience	12 weeks	Likert score 1-5 with higher score being positive
BMI (kg/m2)	change at 12 and 24 weeks	percent change
CGM mean glucose	change at 12 and 24 weeks	mean glucose
PAID-5 problem areas in diabetes	change at 12 and 24 weeks	the scale gives a total score from 0 to 20. A score of 8 and above indicates a high level of diabetes-related distress
perception of behavior modification after CGM use	12 weeks	yes no questions about changes to activity or lifestyle with yes being positive
household/family member perception of lifestyle changes	12 weeks	household members perception of lifestyle changes after family member participated in education with or without CGM with individual yes or no questions with yes being positive
pedometer	change at 12 and 24 weeks	average number of steps per day
The Neighborhood Questionnaire/Neighborhood Safety	baseline	a 16-item tool to assess sociability and an individual's satisfaction with the family's neighborhood. It has three subscales, and we will ask the Neighborhood Safety Subscale (items 1, 6, 10, 11, and 12) as a brief assessment of participants' ability to safely engage in physical activity in their neighborhoods
Self-Efficacy for Diabetes	change at 12 and 24 weeks	the scale is 1-10 and the score is the mean of the eight items. If more than two items are missing, do not score the scale. Higher number indicates higher self-efficacy
Blood pressure systolic and diastolic	change at 12 and 24 weeks	change in blood pressure
physical activity questionnaire IPAQ	12 and 24 weeks	increase or decrease in number of minutes in vigorous and moderate activity and walking in walking time and activity.
CGM percent time in range	change at 12 and 24 weeks	percent time in range( tir)
International Physical Activity Prevalence Study SELF-ADMINISTERED ENVIRONMENTAL MODULE(PANES):	baseline	Questions 2,4,6,9,13,14 and 16 of PANES with be assessed
PHQ9 Depression score	baseline	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.

Trial Locations

Locations (2)

University of Washington Diabetes Institute; 🇺🇸 Seattle, Washington, United States

University of Washington; 🇺🇸 Seattle, Washington, United States