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This study allows Type 2 diabetics to receive feedback from a continuous glucose monitor (CGM) as part of an educational program designed to help them better manage their glucose levels. Subjects will also wear an activity tracker to monitor their activity and observe its effect on their glucose levels. The educational program will involve calls from coaches to check subjects' progress and answer questions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Management Educational Program | Experimental | Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor (CGM) | Device | Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Program Enrollment Rate (%) | (Number of patients who were shipped devices) / (Number of patients invited to enroll) * 100 | up to 9 months |
| Program Completion Rate (%) | (Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) * 100 | up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly Average of Estimated Glucose Values (EGV) | (Sum of EGV for a given week) / (Total number of EGV for a given week) | up to 10 weeks |
| Change in Medication Dosage (mg/Day; U/Day) | (dosage of Rx on Day 180) - (dosage of Rx on Day 0) |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant
Blind
Deaf
Receiving chemotherapy or radiation to treat cancer (now or in past 6 months)
Misusing any drugs (including alcohol, painkillers, hallucinogens, or others)
Critically ill
Diagnosed with or experiencing:
Has had a:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Medical Associates | Las Vegas | Nevada | 89102 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diabetes Management Educational Program | Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels. Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels. Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels. Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diabetes Management Educational Program | Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels. Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels. Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels. Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Two participants lacked age data. |
| 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 | Program Enrollment Rate (%) | (Number of patients who were shipped devices) / (Number of patients invited to enroll) * 100 | Note that the number analyzed is greater than the number of participants (358) because participants are a subset of those who were invited to participate. | Posted | Number | percentage of invitees | up to 9 months |
|
10 weeks per participant
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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 | Diabetes Management Educational Program | Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels. Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels. Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels. Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death from Cardiopulmonary Arrest | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding at Insertion Site | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jared Jones | Savvysherpa, LLC | 763-549-3540 | 8116 | JaredJones@savvysherpa.com |
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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 19, 2017 | May 23, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000072936 | Fitness Trackers |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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| Activity Tracker | Device | Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels. |
|
|
| Coaching | Behavioral | Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging. |
|
| up to 9 months |
| Average Age of Participants Who Start Trial (Yrs) | (Sum of ages of all enrollees) / (Total number of enrollees) | up to 9 months |
| Average Age of Participants Who Complete Trial (Yrs) | (Sum of age of patients who complete) / (Total number who complete) | up to 9 months |
| Texting With Coaches | (Sum of all text messages) / (Total number of participants*days) | up to 9 months |
| Coaching Participation Rate | (Sum of weekly coaching calls completed) / (Total number of participants*weeks) | up to 9 months |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Three participants lacked gender data. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Program Completion Rate (%) | (Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) * 100 | Unit of measure, below, should read, "percentage of participants completing 10 weeks of CGM," but there is not enough space. | Posted | Number | percentage of participants | up to 9 months |
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|
|
| Secondary | Weekly Average of Estimated Glucose Values (EGV) | (Sum of EGV for a given week) / (Total number of EGV for a given week) | 358 Participants started the study, but participants dropped out as time passed. By week 10, there were only 193 participants remaining who were providing EGV. | Posted | Mean | Standard Deviation | milligrams/deciliter | up to 10 weeks |
|
|
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| Secondary | Change in Medication Dosage (mg/Day; U/Day) | (dosage of Rx on Day 180) - (dosage of Rx on Day 0) | After starting the study, administrator realized that it would not be able to obtain medication data from participants. There is no data to report for this measure. | Posted | up to 9 months |
|
|
| Secondary | Average Age of Participants Who Start Trial (Yrs) | (Sum of ages of all enrollees) / (Total number of enrollees) | Two of the 358 participants who started the study lacked age data. | Posted | Mean | Standard Deviation | years | up to 9 months |
|
|
|
| Secondary | Average Age of Participants Who Complete Trial (Yrs) | (Sum of age of patients who complete) / (Total number who complete) | One of the 193 participants who completed 10 weeks of CGM use lacked age data. | Posted | Mean | Standard Deviation | years | up to 9 months |
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|
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| Secondary | Texting With Coaches | (Sum of all text messages) / (Total number of participants*days) | Posted | Number | text messages per participant per day | up to 9 months |
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| Secondary | Coaching Participation Rate | (Sum of weekly coaching calls completed) / (Total number of participants*weeks) | Posted | Number | calls per participant per week | up to 9 months |
|
|
|
| 2 |
| 358 |
| 3 |
| 358 |
| 10 |
| 358 |
| Stroke | Vascular disorders | Non-systematic Assessment |
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| Death from artherosclerotic and hypertensive heart disease | Cardiac disorders | Non-systematic Assessment |
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| Bruising at Insertion Site | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Detached/Broken Sensor Wire | Product Issues | Non-systematic Assessment |
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| Redness/Rash at insertion site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Week 3 |
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| Week 4 |
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| Week 5 |
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| Week 6 |
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| Week 7 |
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| Week 8 |
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| Week 9 |
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| Week 10 |
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