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The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or type 2 diabetes.
This study is a multi-center, randomized, in-clinic trial that aims to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or type 2 diabetes for at least one year.
Subjects are randomized into either Group A or Group B. The groups assigned will determine when the subject will be participating in the in-clinic YSI frequent sample testing (FST). For example on Day 1: Group A begins FST 30 minutes after Enlite 3 Sensor Insertion. Group B begins FST 14 hours after Enlite 3 Sensor Insertion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | Subjects underwent FST at 30 mins, 50 hrs and 146 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR |
|
| Group B | Other | Subjects underwent FST at 14 hrs, 62 hrs and 158 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlite 3 | Device | Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year. |
| Measure | Description | Time Frame |
|---|---|---|
| Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD) | Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose. | 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Retrospective Re-Analysis (MARD With 1 Additional Calibration) | Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values). Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Brazg, M.D | Rainier Clinical Research Center | Principal Investigator |
| Mark Christiansen, M.D | Diablo Clinical Research | Principal Investigator |
| Timothy Bailey, M.D | AMCR Institute | Principal Investigator |
| Satish Garg, M.D | Barbara Davis Center | Principal Investigator |
| Robert Slover, M.D | Barbara Davis Center | Principal Investigator |
| Bruce Bode, M.D | Atlanta Diabetes Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute | Escondido | California | 92026 | United States | ||
| Diablo Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28700272 | Derived | Christiansen MP, Garg SK, Brazg R, Bode BW, Bailey TS, Slover RH, Sullivan A, Huang S, Shin J, Lee SW, Kaufman FR. Accuracy of a Fourth-Generation Subcutaneous Continuous Glucose Sensor. Diabetes Technol Ther. 2017 Aug;19(8):446-456. doi: 10.1089/dia.2017.0087. Epub 2017 Jul 12. |
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118 subjects consented and enrolled in the overall study. Of the 118, 89 subjects utilized the latest sensor version.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A (FST 30 Mins After Sensor Insertion) | Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year. Guardian Mobile App 640G Insulin Pump |
| FG001 | Group B (FST 14 Hrs After Sensor Insertion) | Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year. Guardian Mobile App 640G Insulin Pump |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing. Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year. Guardian Mobile App 640G Insulin Pump |
| 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 | Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD) | Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose. | Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately. | Posted | Mean | Standard Deviation | percentage | 7 Days |
|
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Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.
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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 | Group | Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing. Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year. Guardian Mobile App 640G Insulin Pump |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Smita Barua, Clinical Trial Manager | Medtronic Diabtes | 818.576.5534 | smita.barua@medtronic.com |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| 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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| Guardian Mobile App | Device |
|
| 640G Insulin Pump | Device |
|
| 7 Days |
| Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration) | Retrospective analysis using one GSR: minimum and 3-4 calibrations will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during YSI frequent sample testing. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose. | 7 Days |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | 80045 | United States |
| Barbara Davis Center | Aurora | Colorado | 80045 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Retrospective Re-Analysis (MARD With 1 Additional Calibration) | Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values). Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose. | Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately. | Posted | Mean | Standard Deviation | percentage | 7 Days |
|
|
|
| Secondary | Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration) | Retrospective analysis using one GSR: minimum and 3-4 calibrations will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during YSI frequent sample testing. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose. | Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately. | Posted | Mean | Standard Deviation | percentage | 7 Days |
|
|
|
| 0 |
| 89 |
| 5 |
| 89 |
| worsening of BPH | Reproductive system and breast disorders |
|
| RASH | Skin and subcutaneous tissue disorders |
|
| Upper respiratory infection | Infections and infestations |
|
| Blister | Skin and subcutaneous tissue disorders |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |