Dexcom G6
DeviceDexcom G6 CGM device
Other names: Compañeros en Salud (Partners in Health) curriculum
NCT Number: NCT05394844
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
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
University of Washington, Seattle, Washington, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dexcom G6 CGM device
Other names: Compañeros en Salud (Partners in Health) curriculum
Time frame: change at 12 weeks
Percent change in A1C
Time frame: 12 weeks
mean glucose at 12 weeks
Time frame: 12 WEEKS
percentage of time in range( tir)
Time frame: change at 12 WEEKS
percent change BMI ((kg/m2)
Time frame: change at 12 WEEKS
change in blood pressure
Time frame: 12 weeks
increase or decrease in days of vigorous activity - one question in IPAQ.
Time frame: baseline
Question Neighborhood Questionnaire/Neighborhood Safety questions 1
reported number that felt it was very bad or fairly bad
Time frame: 12 weeks
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.
Time frame: score at 12 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
Time frame: composite score at 12 weeks
The Summary of Diabetes Self-Care Activities asks patient about diabetes self-care activities during the past 7 days and for each activity they can answer 0 days out of the week to a max of 7 days out of the week with higher score indicating more days doing this self -care activity and positive results
Time frame: 12 weeks
Experiences of CGM @Joslin 2009 scale range from 5 (strongly agree) to 1 ( strongly disagree) statements/questions that measured the amount of satisfaction that was derived from use of continuous glucose monitoring. Higher score meant perceived benefit/ better outcome
Time frame: at 12 weeks
Did use of Real-Time- cgm in intervention group contribute to a healthier lifestyle ? yes
Time frame: 12 weeks
household members perception of lifestyle changes after family member participated in education with CGM. Overall, do you feel Continuous Glucose Monitoring contributed to your making changes for a healthier lifestyle? yes
Time frame: at 12 weeks
average number of steps per day
Time frame: score at 12 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
Time frame: baseline
number of participants that had high or marginal food security based on 6 questions (geared to assess access or lack of access to food) composite score
University of Washington
Other
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)
Acronym: CUTDM
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