Diabetes Mellitus
Conditions
Keywords
Diabetes Type I Type II
Brief summary
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.
Detailed description
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).
Interventions
DEVICEGuardian™ Sensor (3)
Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days.
Sponsors
Medtronic Diabetes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is 14 - 75 years of age at time of screening 2. Subject has a clinical diagnosis of type 1 or 2 diabetes as determined via medical record or source documentation by an individual qualified to make a medical diagnosis 3. Subject has adequate venous access as assessed by investigator or appropriate staff 4. Subject is willing to follow the study procedures and willing to come to study visits
Exclusion criteria
1. Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) placement as assessed by qualified individual. 2. Subject has any unresolved adverse skin condition in the area of study device or device placement (e.g., psoriasis, rash, Staphylococcus infection) 3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks 4. Subject is female and has a positive pregnancy screening test 5. Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator 6. Subject is female and plans to become pregnant during the course of the study 7. Subject has a hematocrit (Hct) lower than the normal reference range 8. Subject may not be on the research staff of those performing this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Guardian™ Sensor (3) Values That Are Within 20% Agreement of YSI | 168 Hours | 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. |
| Consensus Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B | 168 Hours | 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. |
| Clarke Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B | 168 Hours | 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. |
| Mean Absolute Relative Difference (MARD) | 168 Hours | 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. |
Countries
China
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Unsuccessful Procedure | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Study Arm |
|---|---|
| Age, Continuous | 45.67 years STANDARD_DEVIATION 17.1 |
| BMI | 23.51 kg/m^2 STANDARD_DEVIATION 3.61 |
| Race/Ethnicity, Customized Han Chinese | 64 Participants |
| Race/Ethnicity, Customized Hui Chinese | 1 Participants |
| Race/Ethnicity, Customized Man Chinese | 1 Participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 66 |
| other Total, other adverse events | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 |
Outcome results
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.
Time frame: 168 Hours
Population: A total of 63 subjects who had Guardian™ Sensor (3) inserted and had at least one paired Guardian™ Sensor (3) value and YSI measurement.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study Arm | Clarke Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B | 99.8 percentage of paired readings |
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.
Time frame: 168 Hours
Population: A total of 63 subjects who had Guardian™ Sensor (3) inserted and had at least one paired Guardian™ Sensor (3) value and YSI measurement.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study Arm | Consensus Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B | 100 percentage of paired readings |
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.
Time frame: 168 Hours
Population: A total of 63 subjects who had Guardian™ Sensor (3) inserted and had at least one paired Guardian™ Sensor (3) value and YSI measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Arm | Mean Absolute Relative Difference (MARD) | 8.11 percentage of difference | Standard Deviation 4.02 |
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.
Time frame: 168 Hours
Population: A total of 63 subjects who had Guardian™ Sensor (3) inserted and had at least one paired Guardian™ Sensor (3) value and YSI measurement.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study Arm | Percentage of Guardian™ Sensor (3) Values That Are Within 20% Agreement of YSI | 93.2 percentage of paired readings |