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The purpose of this study is to demonstrate the performance and safety of the Guardian™ Sensor (3) over 170 hours (7 days) when inserted in the abdomen used in subjects age 14 - 75 years with the Guardian™ Connect System.
This study is a multi-center, prospective single-arm design without controls. Up to 72 subjects will be enrolled in order to have approximately 60 subjects complete the study. Three investigational centers in China will be used during this study.
During the study, each subject will be randomly assigned to one day of the Yellow Springs Instrument (YSI™*) frequent sample testing (FST) (Day 1, 3-5, or 7).Subjects will wear two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days (one which will be paired to the Guardian Connect app and the other will function as a glucose recorder.).
The Guardian Sensor (3)s will be worn in the abdomen area and self-inserted by the subject on same side or opposite sides.
On the evening prior to FST, subjects will be asked to fast for approximately 12 hours and adjust their insulin and medications according to routine care (for example as they would do for fasting lipid panel). Subjects may fast for shorter period of time based on investigator discretion.
The subject should be in fasting status upon arrival hospital to start FST process. The feeding protocol may be modified based on investigator discretion. The duration of FST will be approximately 7 hours.
During the study, subjects will continue with their current diabetes regimen independent of the study devices. Subjects will be instructed by the investigational center that they are not to use the study devices (except for the CONTOUR™* study meter) for the management of their diabetes. The CONTOUR™* study meter may be used for treatment decisions and calibration of Guardian™ Sensor (3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guardian™ Sensor (3) | Device | Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Guardian™ Sensor (3) Values That Are Within 20% Agreement of YSI | Percentage of Guardian™ Sensor (3) Values that are within 20% agreement of Yellow Springs Instrument (YSI) plasma glucose values (±20 mg/dL (1.1 mmol/L) when reference blood glucose (YSI) less than or equal to (≤) 80 mg/dL (4.4 mmol/L) ) during YSI frequent sampling testing (FST) days. | 168 Hours |
| Consensus Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B | A mean rate in Zone A+B of Consensus Error Grid between Guardian Sensor (3) values and YSI™* plasma glucose values during YSI™* FST days was evaluated. Consensus Error Grid (or Parkes error grid) compared the paired primary sensor and YSI reference glucose values. Zone A is defined in the Parkes error grid as the zone of "clinical accurate measurements with no effect on clinical action", Zone B as "altered clinical action with little or no effect on clinical outcome". Ideal situation is 100% in Zone A + B. | 168 Hours |
| Clarke Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B | A mean rate in Zone A+B of Clarke Error Grid between Guardian Sensor (3) values and YSI™* plasma glucose values during YSI™* FST days was evaluated. Clarke Error Grid compared the paired primary sensor and YSI reference glucose values. Zone A are "clinically accurate in that they would lead to clinically correct treatment decisions". Zone B "would lead to benign or no treatment". Ideal situation is 100% in Zone A + B. | 168 Hours |
| Mean Absolute Relative Difference (MARD) | Mean absolute relative difference (MARD) between Guardian Sensor (3) values and YSI™* plasma glucose values during YSI™* FST days was evaluated. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple FST days were pooled together for reporting purpose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Zhou, MD | Shanghai 6th People's Hospital | Principal Investigator |
| Xiaofeng Lv, MD | Seventh Medical Center of PLA Army General Hospital | Principal Investigator |
| Hong Li, MD | Sir Run Run Shaw Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Seventh Medical Center of PLA General Hospital | Beijing | 100700 | China | |||
| Sir Run Run Shaw Hospital |
72 subjects consented and enrolled in the overall study. Of the 72, 3 subjects failed screening, 3 subjects didn't utilize any Guardian™ Sensor (3) , 66 subjects utilized Guardian™ Sensor (3) and were considered to have started in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Arm | Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7). Guardian™ Sensor (3): Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Arm | Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7). Guardian™ Sensor (3): Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days. |
| 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 | Percentage of Guardian™ Sensor (3) Values That Are Within 20% Agreement of YSI | Percentage of Guardian™ Sensor (3) Values that are within 20% agreement of Yellow Springs Instrument (YSI) plasma glucose values (±20 mg/dL (1.1 mmol/L) when reference blood glucose (YSI) less than or equal to (≤) 80 mg/dL (4.4 mmol/L) ) during YSI frequent sampling testing (FST) days. | A total of 63 subjects who had Guardian™ Sensor (3) inserted and had at least one paired Guardian™ Sensor (3) value and YSI measurement. | Posted | Mean | 95% Confidence Interval | percentage of paired readings | 168 Hours |
|
7 days (from sensor insertion to end of 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 | Study Arm | Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7). Guardian™ Sensor (3): Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vivian Chen, Statistician | Medtronic Minimed | 8185763309 | vivian.chen@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2018 | Aug 4, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2019 | Aug 4, 2020 | SAP_001.pdf |
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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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| 168 Hours |
| Hangzhou |
| 310016 |
| China |
| Shanghai Sixth People's Hospital | Shanghai | 200233 | China |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Primary | Consensus Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B | A mean rate in Zone A+B of Consensus Error Grid between Guardian Sensor (3) values and YSI™* plasma glucose values during YSI™* FST days was evaluated. Consensus Error Grid (or Parkes error grid) compared the paired primary sensor and YSI reference glucose values. Zone A is defined in the Parkes error grid as the zone of "clinical accurate measurements with no effect on clinical action", Zone B as "altered clinical action with little or no effect on clinical outcome". Ideal situation is 100% in Zone A + B. | A total of 63 subjects who had Guardian™ Sensor (3) inserted and had at least one paired Guardian™ Sensor (3) value and YSI measurement. | Posted | Mean | 95% Confidence Interval | percentage of paired readings | 168 Hours |
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| Primary | Clarke Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B | A mean rate in Zone A+B of Clarke Error Grid between Guardian Sensor (3) values and YSI™* plasma glucose values during YSI™* FST days was evaluated. Clarke Error Grid compared the paired primary sensor and YSI reference glucose values. Zone A are "clinically accurate in that they would lead to clinically correct treatment decisions". Zone B "would lead to benign or no treatment". Ideal situation is 100% in Zone A + B. | A total of 63 subjects who had Guardian™ Sensor (3) inserted and had at least one paired Guardian™ Sensor (3) value and YSI measurement. | Posted | Mean | 95% Confidence Interval | percentage of paired readings | 168 Hours |
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| Primary | Mean Absolute Relative Difference (MARD) | Mean absolute relative difference (MARD) between Guardian Sensor (3) values and YSI™* plasma glucose values during YSI™* FST days was evaluated. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple FST days were pooled together for reporting purpose. | A total of 63 subjects who had Guardian™ Sensor (3) inserted and had at least one paired Guardian™ Sensor (3) value and YSI measurement. | Posted | Mean | Standard Deviation | percentage of difference | 168 Hours |
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| 0 |
| 66 |
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| 66 |
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| 66 |
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