Diabetes Type 2
Conditions
Keywords
continuous glucose monitoring, diabetes education
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
Interventions
DEVICEDexcom G6
Dexcom G6 CGM device
Sponsors
American Diabetes Association
Washington State University
Sea Mar Community Health Centers
DexCom, Inc.
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Real Time Continuous Glucose Monitoring using Dexcom G6 and Diabetes education
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C | change at 12 weeks | Percent change in A1C |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGM Percentage of Time in Range | 12 WEEKS | percentage of time in range( tir) |
| Percent Change in BMI | change at 12 WEEKS | percent change BMI ((kg/m2) |
| Blood Pressure Systolic | change at 12 WEEKS | change in blood pressure |
| Physical Activity Questionnaire IPAQ | 12 weeks | increase or decrease in days of vigorous activity - one question in IPAQ. |
| International Physical Activity Prevalence Study SELF-ADMINISTERED ENVIRONMENTAL MODULE(PANES): | baseline | 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 |
| PHQ9 Depression Score- Those With PHQ9>15 | 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. |
| PAID-5 Problem Areas in Diabetes Those With Score > 8 | 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 |
| CGM Mean Glucose | 12 weeks | mean glucose at 12 weeks |
| Modified Joslin Diabetes Center CGM Experience | 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 |
| Perception of Behavior Modification After Real-Time- CGM Use | at 12 weeks | Did use of Real-Time- cgm in intervention group contribute to a healthier lifestyle ? yes |
| Household/Family Member Perception of Lifestyle Changes | 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 |
| Pedometer | at 12 weeks | average number of steps per day |
| Self-Efficacy for Diabetes | 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 |
| 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 | 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 |
| Self-care for Diabetes (SDSCA) Number of Days Reporting Self Care | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 61 |
| 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 | 59 |
| Total | 120 |
Baseline characteristics
| Characteristic | CGM With DM Education | Education Only | Total |
|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 9 | 47 years STANDARD_DEVIATION 7 | 46 years STANDARD_DEVIATION 8 |
| education highschool or less | 55 participants | 54 participants | 109 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 61 Participants | 59 Participants | 120 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| income less than 49,999 | 35 participants | 39 participants | 74 participants |
| insurance- self pay | 44 Participants | 36 Participants | 80 Participants |
| preferred primary language spanish | 59 participants | 58 participants | 117 participants |
| Region of Enrollment United States | 61 participants | 59 participants | 120 participants |
| Sex: Female, Male Female | 29 Participants | 24 Participants | 53 Participants |
| Sex: Female, Male Male | 32 Participants | 35 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 59 |
| other Total, other adverse events | 0 / 61 | 0 / 59 |
| serious Total, serious adverse events | 0 / 61 | 0 / 59 |
Outcome results
Primary
Hemoglobin A1C
Percent change in A1C
Time frame: change at 12 weeks
Population: change in A1c over 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CGM With DM Education | Hemoglobin A1C | -2.3 percent change in A1C |
| Education Only | Hemoglobin A1C | -1.5 percent change in A1C |
Secondary
Blood Pressure Systolic
change in blood pressure
Time frame: change at 12 WEEKS
Population: those with blood pressure available 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CGM With DM Education | Blood Pressure Systolic | -2.5 mmHg |
| Education Only | Blood Pressure Systolic | -0.3 mmHg |
Secondary
CGM Mean Glucose
mean glucose at 12 weeks
Time frame: 12 weeks
Population: those that had baseline and 12 week CGM data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM With DM Education | CGM Mean Glucose | 208.4 mg/dl | Standard Deviation 62.5 |
| Education Only | CGM Mean Glucose | 239.6 mg/dl | Standard Deviation 84.4 |
Secondary
CGM Percentage of Time in Range
percentage of time in range( tir)
Time frame: 12 WEEKS
Population: THOSE WITH CGM DATA AVAILABLE AT 12 WEEKS
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CGM With DM Education | CGM Percentage of Time in Range | 13.2 percentage of tir |
| Education Only | CGM Percentage of Time in Range | 6.2 percentage of tir |
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
Time frame: baseline
Population: those that completed survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM With DM Education | 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 | 30 Participants |
| Education Only | 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 | 37 Participants |
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
Time frame: 12 weeks
Population: number of household members that completed the survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM With DM Education | Household/Family Member Perception of Lifestyle Changes | 13 Participants |
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
Time frame: baseline
Population: those that completed survey and felt bad or fairly bad about neighborhood
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM With DM Education | International Physical Activity Prevalence Study SELF-ADMINISTERED ENVIRONMENTAL MODULE(PANES): | 3 Participants |
| Education Only | International Physical Activity Prevalence Study SELF-ADMINISTERED ENVIRONMENTAL MODULE(PANES): | 9 Participants |
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
Time frame: 12 weeks
Population: participant who completed questionnaire and wore real-time CGM
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM With DM Education | Modified Joslin Diabetes Center CGM Experience | 4.33 score on a scale | Standard Deviation 0.55 |
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
Time frame: score at 12 weeks
Population: those with questionnaire available at 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM With DM Education | PAID-5 Problem Areas in Diabetes Those With Score > 8 | 13 Participants |
| Education Only | PAID-5 Problem Areas in Diabetes Those With Score > 8 | 11 Participants |
Secondary
Pedometer
average number of steps per day
Time frame: at 12 weeks
Population: those that had pedometry data at 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM With DM Education | Pedometer | 6931 number of steps per day | Standard Deviation 3680 |
| Education Only | Pedometer | 4703 number of steps per day | Standard Deviation 1567 |
Secondary
Percent Change in BMI
percent change BMI ((kg/m2)
Time frame: change at 12 WEEKS
Population: THOSE WITH 12 WEEKS BMI AVAILABLE
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CGM With DM Education | Percent Change in BMI | -1 % bmi CHANGE |
| Education Only | Percent Change in BMI | -2.4 % bmi CHANGE |
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
Time frame: at 12 weeks
Population: particpants who completed questionnaire
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM With DM Education | Perception of Behavior Modification After Real-Time- CGM Use | 36 Participants |
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.
Time frame: 12 weeks
Population: those that completed questionnaire are 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM With DM Education | PHQ9 Depression Score- Those With PHQ9>15 | 5 Participants |
| Education Only | PHQ9 Depression Score- Those With PHQ9>15 | 7 Participants |
Secondary
Physical Activity Questionnaire IPAQ
increase or decrease in days of vigorous activity - one question in IPAQ.
Time frame: 12 weeks
Population: THOSE WITH questionnaire Available 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM With DM Education | Physical Activity Questionnaire IPAQ | 1 number of days | Standard Deviation 3.8 |
| Education Only | Physical Activity Questionnaire IPAQ | 0.14 number of days | Standard Deviation 1.45 |
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
Time frame: composite score at 12 weeks
Population: those with questionnaire available at 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM With DM Education | Self-care for Diabetes (SDSCA) Number of Days Reporting Self Care | 5.3 days | Standard Deviation 2.04 |
| Education Only | Self-care for Diabetes (SDSCA) Number of Days Reporting Self Care | 3.3 days | Standard Deviation 2.18 |
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
Time frame: score at 12 weeks
Population: those that completed survey at 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM With DM Education | Self-Efficacy for Diabetes | 8.5 units on a scale | Standard Deviation 1.4 |
| Education Only | Self-Efficacy for Diabetes | 7.7 units on a scale | Standard Deviation 1.6 |