Diabetes Education With Real-time Continuous Glucose Monitoring

Diabetes Type 2 Clinical Trial

— CUTDM  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05394844
• Other study ID #: STUDY00014396
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: September 2023
• Source: University of Washington
• Contact: nicole ehrhardt
• Phone: 2065208500
• Email: nehrhard[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Device:
• Dexcom G6
Dexcom G6 CGM device

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington
United States	University of Washington Diabetes Institute	Seattle	Washington

Sponsors (5)

Lead Sponsor	Collaborator
University of Washington	American Diabetes Association, DexCom, Inc., Sea Mar Community Health Centers, Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1C	average glucose over 3 months	change at 12 and 24 weeks after education intervention
Secondary	CGM mean glucose	mean glucose	change at 12 and 24 weeks
Secondary	CGM percent time in range	percent time in range( tir)	change at 12 and 24 weeks
Secondary	BMI (kg/m2)	percent change	change at 12 and 24 weeks
Secondary	Blood pressure systolic and diastolic	change in blood pressure	change at 12 and 24 weeks
Secondary	physical activity questionnaire IPAQ	increase or decrease in number of minutes in vigorous and moderate activity and walking in walking time and activity.	12 and 24 weeks
Secondary	International Physical Activity Prevalence Study SELF-ADMINISTERED ENVIRONMENTAL MODULE(PANES):	Questions 2,4,6,9,13,14 and 16 of PANES with be assessed	baseline
Secondary	PHQ9 Depression score	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.	baseline
Secondary	PAID-5 problem areas in diabetes	the scale gives a total score from 0 to 20. A score of 8 and above indicates a high level of diabetes-related distress	change at 12 and 24 weeks
Secondary	Self-care for diabetes (SDSCA)	. 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.	change at 12 and 24 weeks
Secondary	modified joslin diabetes center CGM experience	Likert score 1-5 with higher score being positive	12 weeks
Secondary	perception of behavior modification after CGM use	yes no questions about changes to activity or lifestyle with yes being positive	12 weeks
Secondary	household/family member perception of lifestyle changes	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	12 weeks
Secondary	pedometer	average number of steps per day	change at 12 and 24 weeks
Secondary	The Neighborhood Questionnaire/Neighborhood Safety	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	baseline
Secondary	Self-Efficacy for Diabetes	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	change at 12 and 24 weeks