Diabetes Education With Real-time Continuous Glucose Monitoring

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Diabetes Type 2

Intervention / Treatment
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* Device: Dexcom G6


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants adults 18-60 years old Self-identify as Latinx Have had a clinical diagnosis of T2D within the last 15 years with or without medication use Have an A1C ≥8.0% at screening Own or have routine access to a personal device that allows attending educational sessions virtually Be physically and cognitively able to use the home CGM monitoring device Be willing and able to follow all other study procedures Exclusion Criteria Exclusion Criteria. Duration of diabetes >15 years Type 1 diabetes or latent autoimmune diabetes Current use of prandial insulin Any condition that prevents walking at least 1 city block History of serious mental illness other than adequately treated depression History of bariatric surgery or current participation in a weight management program Current diagnosis of cancer or other serious or systemic medical condition Significant active cardio- or cerebrovascular disease after review by PI Pregnancy know history x of of hypoglycemia unawareness 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Real Time Continuous Glucose Monitoring using Dexcom G6 and Diabetes education
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CGM with DM education<br>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 | Device: Dexcom G6<br>* Dexcom G6 CGM device<br>* Other names: Compañeros en Salud (Partners in Health) curriculum;|
| No Intervention: Education only<br>If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1C | average glucose over 3 months | change at 12 and 24 weeks after education intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGM mean glucose | mean glucose | change at 12 and 24 weeks | 
| CGM percent time in range | percent time in range( tir) | change at 12 and 24 weeks | 
| BMI (kg/m2) | percent change | change at 12 and 24 weeks | 
| Blood pressure systolic and diastolic | change in blood pressure | change at 12 and 24 weeks | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| modified joslin diabetes center CGM experience | Likert score 1-5 with higher score being positive | 12 weeks | 
| perception of behavior modification after CGM use | yes no questions about changes to activity or lifestyle with yes being positive | 12 weeks | 
| 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 | 
| pedometer | average number of steps per day | change at 12 and 24 weeks | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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continuous glucose monitoring, diabetes education