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To establish the performance of the Dexcom G4 Platinum with a Modified Algorithm continuous monitoring system when compared to a laboratory reference measurement.
A study to evaluate the performance of a modification to the G4 Platinum CGM system in adults with diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Glucose Monitoring System | Experimental | Single-Arm, CGM Device Glucose challenge performed during a clinic session to obtain accuracy data for the CGM system compared to a venous reference measurement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring | Device | A prescribed clinic session day for participating subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement. | The percentage of CGM system values that are within 20% of the reference value for YSI glucose levels > 80 mg/dL or within 20 mg/dL at the reference glucose levels < 80 mg/dL. | 7-day wear period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andy Balo | DexCom, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Muir Physician Network Clinical Research | Concord | California | 94520 | United States | ||
| AMCR Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25961446 | Derived | Peyser TA, Nakamura K, Price D, Bohnett LC, Hirsch IB, Balo A. Hypoglycemic Accuracy and Improved Low Glucose Alerts of the Latest Dexcom G4 Platinum Continuous Glucose Monitoring System. Diabetes Technol Ther. 2015 Aug;17(8):548-54. doi: 10.1089/dia.2014.0415. Epub 2015 May 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Real Time Continuous Glucose Monitoring System | Real Time Continuous Glucose Monitoring System Wear over a 7 day period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Type 1 and Type 2 diabetes patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Real Time Continuous Glucose Monitoring System | Real Time Continuous Glucose Monitoring System Wear over a 7 day period |
| 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 | The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement. | The percentage of CGM system values that are within 20% of the reference value for YSI glucose levels > 80 mg/dL or within 20 mg/dL at the reference glucose levels < 80 mg/dL. | For the demographic and other baseline characteristic information, data from all 51 enrolled subjects was summarized. | Posted | Number | Units analyzed% matched pairs w/i %20/20 | 7-day wear period |
|
7 days of continuous glucose monitoring system use.
AEs assessed for all participants enrolled into the study
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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 | Real Time Continuous Glucose Monitoring System | Real Time Continuous Glucose Monitoring System Wear over a 7 day period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blister, skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Skin blister from study procedures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Balo/ EVP | Dexcom, Inc | 8582000203 | abalo@dexcom.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Escondido |
| California |
| 92026 |
| United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| years old |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 1 |
| 51 |
|
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| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |