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| Name | Class |
|---|---|
| American Diabetes Association | OTHER |
| Washington State University | OTHER |
| Sea Mar Community Health Centers | OTHER |
| DexCom, Inc. |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM with DM education | Active Comparator | 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 |
|
| Education only | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G6 | Device | Dexcom G6 CGM device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C | Percent change in A1C | change at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CGM Mean Glucose | mean glucose at 12 weeks | 12 weeks |
| CGM Percentage of Time in Range | percentage of time in range( tir) | 12 WEEKS |
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Inclusion Criteria:
Exclusion Criteria
Exclusion Criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Diabetes Institute | Seattle | Washington | 98109 | United States | ||
| University of Washington |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38154895 | Derived | Ehrhardt N, Cedeno B, Montour L, Sinclair K, Ferguson G, Berberian P, Comstock B, Wright L. Effectiveness of a culturally tailored diabetes education curriculum with real-time continuous glucose monitoring in a Latinx population with type 2 diabetes: the CUT-DM with CGM for Latinx randomised controlled trial study protocol. BMJ Open. 2023 Dec 28;13(12):e082005. doi: 10.1136/bmjopen-2023-082005. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CGM With DM Education | 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 Dexcom G6: Dexcom G6 CGM device |
| FG001 | Education Only | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CGM With DM Education | 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 Dexcom G6: Dexcom G6 CGM device |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemoglobin A1C | Percent change in A1C | change in A1c over 12 weeks | Posted | Mean | 95% Confidence Interval | percent change in A1C | change at 12 weeks |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CGM With DM Education | 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 Dexcom G6: Dexcom G6 CGM device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr nicole ehrhardt | uwashington | 2404479566 | nehrhard@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2023 | Oct 31, 2025 | Prot_SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 22, 2023 | Oct 31, 2025 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| INDUSTRY |
Real Time Continuous Glucose Monitoring using Dexcom G6 and Diabetes education
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| Percent Change in BMI | percent change BMI ((kg/m2) | change at 12 WEEKS |
| Blood Pressure Systolic | change in blood pressure | change at 12 WEEKS |
| Physical Activity Questionnaire IPAQ | increase or decrease in days of vigorous activity - one question in IPAQ. | 12 weeks |
| International Physical Activity Prevalence Study SELF-ADMINISTERED ENVIRONMENTAL MODULE(PANES): | Question Neighborhood Questionnaire/Neighborhood Safety questions 1 1. In general, how do you feel about your neighborhood? Do you feel it's a very bad, a fairly bad, a fairly good, or a very good place to live? reported number that felt it was very bad or fairly bad | baseline |
| PHQ9 Depression Score- Those With PHQ9>15 | 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. | 12 weeks |
| PAID-5 Problem Areas in Diabetes Those With Score > 8 | the scale gives a total score from 0 to 20. A score of 8 and above indicates a high level of diabetes-related distress | score at 12 weeks |
| Self-care for Diabetes (SDSCA) Number of Days Reporting Self Care | 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 | composite score at 12 weeks |
| Modified Joslin Diabetes Center CGM Experience | 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 | 12 weeks |
| Perception of Behavior Modification After Real-Time- CGM Use | Did use of Real-Time- cgm in intervention group contribute to a healthier lifestyle ? yes | at 12 weeks |
| Household/Family Member Perception of Lifestyle Changes | 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 | 12 weeks |
| Pedometer | average number of steps per day | at 12 weeks |
| 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 | score at 12 weeks |
| Food Insecurity Short Form 6 Question Composite With Score Reported as a Composite: High or Marginal Food Security, Low Food Security, Very Low Food Security | 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 | baseline |
| Seattle |
| Washington |
| 98109 |
| United States |
| Education Only |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| income less than 49,999 | Number | participants |
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| preferred primary language spanish | Number | participants |
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| education highschool or less | Number | participants |
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| insurance- self pay | Count of Participants | Participants |
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| Secondary | CGM Mean Glucose | mean glucose at 12 weeks | those that had baseline and 12 week CGM data | Posted | Mean | Standard Deviation | mg/dl | 12 weeks |
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| Secondary | CGM Percentage of Time in Range | percentage of time in range( tir) | THOSE WITH CGM DATA AVAILABLE AT 12 WEEKS | Posted | Mean | 95% Confidence Interval | percentage of tir | 12 WEEKS |
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| Secondary | Percent Change in BMI | percent change BMI ((kg/m2) | THOSE WITH 12 WEEKS BMI AVAILABLE | Posted | Mean | 95% Confidence Interval | % bmi CHANGE | change at 12 WEEKS |
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| Secondary | Blood Pressure Systolic | change in blood pressure | those with blood pressure available 12 weeks | Posted | Mean | 95% Confidence Interval | mmHg | change at 12 WEEKS |
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| Secondary | Physical Activity Questionnaire IPAQ | increase or decrease in days of vigorous activity - one question in IPAQ. | THOSE WITH questionnaire Available 12 weeks | Posted | Mean | Standard Deviation | number of days | 12 weeks |
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| Secondary | International Physical Activity Prevalence Study SELF-ADMINISTERED ENVIRONMENTAL MODULE(PANES): | Question Neighborhood Questionnaire/Neighborhood Safety questions 1 1. In general, how do you feel about your neighborhood? Do you feel it's a very bad, a fairly bad, a fairly good, or a very good place to live? reported number that felt it was very bad or fairly bad | those that completed survey and felt bad or fairly bad about neighborhood | Posted | Count of Participants | Participants | baseline |
|
|
|
| Secondary | PHQ9 Depression Score- Those With PHQ9>15 | 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. | those that completed questionnaire are 12 weeks | Posted | Count of Participants | Participants | 12 weeks |
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|
|
| Secondary | PAID-5 Problem Areas in Diabetes Those With Score > 8 | the scale gives a total score from 0 to 20. A score of 8 and above indicates a high level of diabetes-related distress | those with questionnaire available at 12 weeks | Posted | Count of Participants | Participants | score at 12 weeks |
|
|
|
| Secondary | Self-care for Diabetes (SDSCA) Number of Days Reporting Self Care | 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 | those with questionnaire available at 12 weeks | Posted | Mean | Standard Deviation | days | composite score at 12 weeks |
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| Secondary | Modified Joslin Diabetes Center CGM Experience | 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 | participant who completed questionnaire and wore real-time CGM | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
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| Secondary | Perception of Behavior Modification After Real-Time- CGM Use | Did use of Real-Time- cgm in intervention group contribute to a healthier lifestyle ? yes | particpants who completed questionnaire | Posted | Count of Participants | Participants | at 12 weeks |
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| Secondary | Household/Family Member Perception of Lifestyle Changes | 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 | number of household members that completed the survey | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Pedometer | average number of steps per day | those that had pedometry data at 12 weeks | Posted | Mean | Standard Deviation | number of steps per day | at 12 weeks |
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| 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 | those that completed survey at 12 weeks | Posted | Mean | Standard Deviation | units on a scale | score at 12 weeks |
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| Secondary | Food Insecurity Short Form 6 Question Composite With Score Reported as a Composite: High or Marginal Food Security, Low Food Security, Very Low Food Security | 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 | those that completed survey | Posted | Count of Participants | Participants | baseline |
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|
| 0 |
| 61 |
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | Education Only | 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 | 0 | 59 | 0 | 59 | 0 | 59 |
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| D004700 | Endocrine System Diseases |