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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 signed a consent form)/(Number of patients invited to enroll) | up to three months |
| Program Completion Rate (%) | (Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form) | up to six months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in A1c Measurement (%) | (Final A1c measure)-(Initial A1c measure) | Day 0 and Day 180 |
| Weekly Average of Estimated Glucose Values (EGV) (Average) | (Sum of EGV for one week)/(Total number of EGV) |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant
Blind
Deaf
Currently receiving chemotherapy or radiation therapy to treat cancer
Addicted to 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 |
|---|---|---|---|---|---|---|
| Rogelio Machuca, MD Family Medicine, PLLC | Las Vegas | Nevada | 89104 | United States |
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364 candidates were contacted. Of those, 52 enrolled.
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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, Categorical | Count of Participants |
| 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 signed a consent form)/(Number of patients invited to enroll) | 52 participants enrolled in the study. Hence, 52 participants analyzed. However, enrollment rate is the number of participants enrolled (52) divided by the number of candidates contacted (364). This explains why the Overall Number of Participants Analyzed is greater than the number Started in the Participant Flow. | Posted | Number | Percentage of participants | up to three months |
|
Up to 8 months
AE and SAE were monitored in three ways:
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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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment | Bleeding at CGM sensor insertion site. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jared Jones, PhD | Savvysherpa, Inc. | 7635493540 | 8116 | JaredJones@savvysherpa.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 23, 2017 | Sep 11, 2018 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 18, 2017 | Apr 10, 2019 | ICF_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 six months |
| Change in Medication Dosage (mg/Day; U/Day) | (dosage of Rx on Day 180)-(dosage of Rx on Day 0) | up to six months |
| Average Age of Participants Who Start Trial (Yrs) | (Sum of ages of all enrollees)/(Total number of enrollees) | up to three months |
| Average Age of Participants Who Complete Trial (Yrs) | (Sum of age of patients who complete)/(Total number who complete) | up to six months |
| Race of Participants Who Start the Trial (n) | Sum of American Indian or Alaska Native, Sum of Asian, Sum of Black or African American, Sum of Native Hawaiian or Other Pacific Islander, Sum of White | up to three months |
| Ethnicity of Participants Who Start the Trial (n) | Sum of Hispanic or Latino and Sum of Not Hispanic or Latino | up to three months |
| Texting With Coaches (Daily Average of Text Messages) | (Sum of all text messages)/(Total number of days) | up to six months |
| Coaching Participation Rate | (Sum of weekly coaching calls completed)/(Total number of weeks) | up to six months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | Program Completion Rate (%) | (Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form) | Posted | Number | Percentage of participants | up to six months |
|
|
|
| Secondary | Change in A1c Measurement (%) | (Final A1c measure)-(Initial A1c measure) | Lack of study resources to collect sufficient information on this variable. | Posted | Day 0 and Day 180 |
|
|
| Secondary | Weekly Average of Estimated Glucose Values (EGV) (Average) | (Sum of EGV for one week)/(Total number of EGV) | Lack of study resources to collect sufficient information on this variable. | Posted | up to six months |
|
|
| Secondary | Change in Medication Dosage (mg/Day; U/Day) | (dosage of Rx on Day 180)-(dosage of Rx on Day 0) | Lack of study resources to collect adequate information on this variable. | Posted | up to six months |
|
|
| Secondary | Average Age of Participants Who Start Trial (Yrs) | (Sum of ages of all enrollees)/(Total number of enrollees) | Lack of study resources to collect adequate information on this variable. | Posted | up to three months |
|
|
| Secondary | Average Age of Participants Who Complete Trial (Yrs) | (Sum of age of patients who complete)/(Total number who complete) | Lack of study resources to collect sufficient data on outcome variable. | Posted | up to six months |
|
|
| Secondary | Race of Participants Who Start the Trial (n) | Sum of American Indian or Alaska Native, Sum of Asian, Sum of Black or African American, Sum of Native Hawaiian or Other Pacific Islander, Sum of White | Lack of study resources to collect sufficient data on outcome variable. | Posted | up to three months |
|
|
| Secondary | Ethnicity of Participants Who Start the Trial (n) | Sum of Hispanic or Latino and Sum of Not Hispanic or Latino | Lack of study resources to collect sufficient data on outcome variable. | Posted | up to three months |
|
|
| Secondary | Texting With Coaches (Daily Average of Text Messages) | (Sum of all text messages)/(Total number of days) | Lack of study resources to collect sufficient data on outcome variable. | Posted | up to six months |
|
|
| Secondary | Coaching Participation Rate | (Sum of weekly coaching calls completed)/(Total number of weeks) | Lack of study resources to collect sufficient data on outcome variable. | Posted | up to six months |
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 2 |
| 52 |
|
| Pain | Skin and subcutaneous tissue disorders | Systematic Assessment | Pain at CGM sensor insertion site |
|
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