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| Name | Class |
|---|---|
| Verizon Foundation | OTHER |
| DHR Health Institute for Research and Development | OTHER |
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The goal of this study is to evaluate the impact of a comprehensive diabetes education and management program based on frequent communication with patients using teleconsultation, text messaging, and phone calls on diabetes related outcomes in Latino patients with type 2 diabetes. The investigators hypothesize that the decline in hemoglobin A1c value between the baseline and the six-month visit will be at least 0.5 percent greater in the intervention group than in the control group.
In this study participants will be followed for a period of 9 months. The control group will receive usual care during this period of time. While, the intervention group will be part of a diabetes education and management program lasting 6 months via a smartphone participants will receive. The 6 month intervention will be followed by a 3 month observation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients in this group will attend regular clinical and education appointments as offered by the clinic for their diabetes care. | |
| Intervention | Experimental | Patients in this group will be part of a Virtual Diabetes Self-Care and Education Program. They will receive a phone to communicate with a diabetes educator for 6 months. They will connect with the diabetes educator for weekly video conferences of up to 30 minutes for twelve consecutive weeks, followed by 7 phone calls. Additionally, they will receive a weekly text message about diabetes for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Diabetes Self-Care and Education Program | Behavioral | Participants will be able to have frequent contact in order to share physical activity and glucose data with the diabetes educator using the smartphone they will receive. Information downloaded to the Glooko Population Management tool can be shared with the diabetes educator. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | The A1C test is a blood test used to diagnose type 2 diabetes and then to manage diabetes. It is measured as a percent. | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvia E Rosas, MD | Joslin Diabetes Center | Principal Investigator |
| Marcel Twahirwa, MD | Doctors Hospital at Reinassance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doctors Hospital at Renaissance | Edinburg | Texas | 78539 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients in this group will attend regular clinical and education appointments as offered by the clinic for their diabetes care. |
| FG001 | Intervention | Patients in this group will be part of a Virtual Diabetes Self-Care and Education (DSME) Program. They will receive a phone to communicate with a diabetes educator (DE) for 6 months. They will connect with the DE for weekly video conferences of up to 30 minutes for twelve consecutive weeks, followed by 7 phone calls. They will receive a weekly text message about diabetes for 6 months. Virtual (DSME) Program: Participants will have frequent contact in order to share physical activity and glucose data with the DE using the smartphone they will receive. Information downloaded to the Glooko Population Management tool can be shared with the DE. Fitbit: Participants will be given a Fitbit physical activity tracker which they can use to record their activity and share the information with the diabetes educator using the device's smartphone application. Smartphone: All virtual visits were performed via provided smartphone. Participants will receive a Glooko MeterSyn |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients in this group will attend regular clinical and education appointments as offered by the clinic for their diabetes care. |
| BG001 | Intervention | Patients (pt) in this group will be part of a Virtual Diabetes Self-Care and Education (DSME) Program. Pt will receive a phone to connect with a diabetes educator (DE) for 6 months. Pt will have a weekly video call of up to 30 min. with the DE for 12 weeks, followed by 7 phone calls. Pt will get a weekly text message about diabetes for 6 months. Virtual DSME Program: pt will have frequent contact in order to share physical activity and glucose data with the DE using smartphone. Information downloaded to the Glooko can be shared with the DE. Fitbit: Participants will be given a Fitbit physical activity tracker which they can use to record their activity and share the information with the DE using the device's smartphone application. Smartphone: All virtual visits were performed via. In addition, pt will receive a Glooko MeterSync which is able to connect to most glucose meters in order to download glucose data to the Glooko Population Management tool on their smartphones |
| Units | Counts |
|---|---|
| Participants |
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| 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 | The A1C test is a blood test used to diagnose type 2 diabetes and then to manage diabetes. It is measured as a percent. | Posted | Mean | Standard Deviation | percentage of A1C | 9 months |
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We did not collect any adverse events as this was a behavioral intervention that did not modify standards of care
While we did not monitor for mortality, there were no reports of patient death during the study period.
Serious adverse events were not monitored. Other adverse events were not monitored.
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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 | Control | Patients in this group will attend regular clinical and education appointments as offered by the clinic for their diabetes care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sylvia Rosas | Joslin Diabetes Center | 6173092486 | sylvia.rosas@joslin.harvard.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 | Oct 27, 2015 | Mar 3, 2022 | Prot_SAP_000.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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| Fitbit | Device | Participants will be given a Fitbit physical activity tracker which they can use to record their activity and share the information with the diabetes educator using the device's smartphone application. |
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| Smartphone | Device | All virtual visits were performed via provided smartphone. In addition, participants will receive a Glooko MeterSync Blue cable which is able to connect to most glucose meters in order to download glucose data to the Glooko Population Management tool on their smartphones |
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| BG002 | Total | Total of all reporting groups |
| years |
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| 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 | Count of Participants | Participants |
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| Hemoglobin A1C | Mean | Standard Deviation | % |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Intervention | Patients in this group will be part of a Virtual Diabetes Self-Care and Education (DSME) Program. They will receive a phone to communicate with a diabetes educator for 6 months. They will connect with the diabetes educator for weekly video conferences of up to 30 minutes for twelve consecutive weeks, followed by 7 phone calls. Additionally, they will receive a weekly text message about diabetes for 6 months. Virtual (DSME) Program: Participants will be able to have frequent contact in order to share physical activity and glucose data with the diabetes educator using the smartphone they will receive. Information downloaded to the Glooko Population Management tool can be shared with the diabetes educator. Fitbit: Participants will be given a Fitbit physical activity tracker which they can use to record their activity and share the information with the diabetes educator using the device's smartphone application. Smartphone: All virtual visits were performed vi | 0 | 0 | 0 | 0 | 0 | 0 |
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| D004700 | Endocrine System Diseases |