Insulin Requiring Diabetes
Conditions
Keywords
Insulin requiring diabetes, Children, Sensor, Accuracy
Brief summary
The purpose of this study is to evaluate the Enlite Sensor™ and Enlite 3 Sensor performance in pediatric patients with insulin requiring diabetes at the beginning, middle and end of sensor wear.
Detailed description
This study is a prospective, single arm, multi-center, in-clinic study.. There will be two consecutive phases of the study: A total of up to 260 subjects (2-18 years old) will be enrolled at up to 15 investigational centers Subjects will come for clinic visit for YSI reference glucose testing and for Enlite Sensor™ and Enlite 3 Sensor™ testing. SMBG (Self-Monitoring of Blood Glucose) reference measurement is for subjects 2-6 years of age and cannot tolerate YSI. Study has a run-in period and a study period with a total of 10 visits
Interventions
DEVICEEnlite sensors
Subject wears enlite sensor first and followed by enlite 3 sensor.
Sponsors
Medtronic Diabetes
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is 2-18 years of age at time of screening 2. Subject has been diagnosed with insulin requiring diabetes mellitus for at least one year. 3. Subject is willing to perform greater than or equal to 4 finger stick blood glucose measurements daily 4. Subject is willing to perform required sensor calibrations 5. Subject is willing to wear the system (Guardian Mobile application, pumps, sensors, meter) continuously throughout the study 6. Adequate venous access as assessed by investigator or appropriate staff
Exclusion criteria
1. Subject is unable to tolerate tape adhesive in the area of sensor placement 2. Subject has any unresolved adverse skin condition in the area of sensor 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. Females of child-bearing potential who have a positive pregnancy test at screening or plans to become pregnant during the course of the study 5. Subjects with hematocrit lower than the normal age specific reference range per central or local lab testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump | 6 days | Enlite Sensor accuracy relative to the YSI (Yellow Spring Instruments) reference. Each subject wore two 530G pumps. The results for the lower serial number pump worn by each subject were arbitrarily selected and pooled across subjects for the primary dataset. 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 testing days were pooled together for reporting purpose. |
| Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System | 7 days | Enlite 3 Sensor accuracy using Guardian Mobile System compared to YSI or SMBG (Self-Monitoring of Blood Glucose) reference values. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) \* 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump, Using One Additional Calibration During FST | 6 Days | Enlite Sensor accuracy relative to the YSI reference, using one additional calibration during FST. 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 testing days were pooled together for reporting purpose. |
| Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump, Using One Additional Calibration During FST | 6 Days | Enlite Sensor accuracy relative to the YSI reference, using one additional calibration during FST. 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 testing days were pooled together for reporting purpose. |
| Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the GST3C Transmitter | 7 days | Enlite 3 Sensor accuracy using GST3C transmitter used as a recorder compared to YSI or SMBG reference values. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) \* 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose. |
| Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With GST3C Transmitter, Using One Additional Calibration During FST | 7 Days | Enlite 3 Sensor accuracy using GST3C transmitter used as a recorder compared to YSI or SMBG reference values, with one additional calibration during FST. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) \* 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose. |
| Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System, Using One Additional Calibration During FST | 7 Days | Enlite 3 Sensor accuracy using Guardian Mobile System compared to YSI or SMBG reference values, with one additional calibration during FST. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) \* 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose. |
| Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump | 6 Days | Enlite Sensor accuracy relative to the YSI reference. Each subject wore two 530G pumps. The results for the higher serial number pump worn by each subject were arbitrarily selected and pooled across subjects for the secondary dataset. 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 testing days were pooled together for reporting purpose. |
Countries
United States
Participant flow
Pre-assignment details
Two phase study: Enlite and Enlite 3. Some participated only Enlite phase and some only participated in Enlite 3 phase.
Participants by arm
| Arm | Count |
|---|---|
| 2-18 Year Olds Wearing Enlite Sensor 2-18 years old wearing Enlite and/or Enlite3 sensors. | 186 |
| Total | 186 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Enlite 1 Period | Adverse Event | 1 |
| Enlite 1 Period | Inclusion/Exclusion not met | 1 |
| Enlite 1 Period | Withdrawal by Subject | 18 |
| Enlite 3 Period | DUE TO MULTIPLE SENSOR ISSUES | 1 |
| Enlite 3 Period | Lost to Follow-up | 1 |
| Enlite 3 Period | Physician Decision | 2 |
Baseline characteristics
| Characteristic | 2-18 Year Olds Wearing Enlite Sensor |
|---|---|
| Age, Continuous | 13.2 years STANDARD_DEVIATION 3.79 |
| Region of Enrollment United States | 186 participants |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 161 | 0 / 158 |
| other Total, other adverse events | 25 / 161 | 23 / 158 |
| serious Total, serious adverse events | 2 / 161 | 1 / 158 |
Outcome results
Primary
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System
Enlite 3 Sensor accuracy using Guardian Mobile System compared to YSI or SMBG (Self-Monitoring of Blood Glucose) reference values. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) \* 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose.
Time frame: 7 days
Population: a total of 25 subjects do not have device data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enlite Sensor Accuracy MARD, Lower Serial Number | Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System | 10.88 percentage of difference | Standard Deviation 10.65 |
Primary
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump
Enlite Sensor accuracy relative to the YSI (Yellow Spring Instruments) reference. Each subject wore two 530G pumps. The results for the lower serial number pump worn by each subject were arbitrarily selected and pooled across subjects for the primary dataset. 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 testing days were pooled together for reporting purpose.
Time frame: 6 days
Population: All subjects wearing Enlite sensor with lower serial number of 530G pump. A total of 30 subjects did not have device data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enlite Sensor Accuracy MARD, Lower Serial Number | Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump | 15.02 percentage of difference | Standard Deviation 13.37 |
Secondary
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With GST3C Transmitter, Using One Additional Calibration During FST
Enlite 3 Sensor accuracy using GST3C transmitter used as a recorder compared to YSI or SMBG reference values, with one additional calibration during FST. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) \* 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose.
Time frame: 7 Days
Population: A total of 41 subjects did not have device data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enlite Sensor Accuracy MARD, Lower Serial Number | Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With GST3C Transmitter, Using One Additional Calibration During FST | 10.85 percentage of difference | Standard Deviation 10.35 |
Secondary
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the GST3C Transmitter
Enlite 3 Sensor accuracy using GST3C transmitter used as a recorder compared to YSI or SMBG reference values. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) \* 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose.
Time frame: 7 days
Population: A total of 41 subjects did not have device data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enlite Sensor Accuracy MARD, Lower Serial Number | Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the GST3C Transmitter | 11.08 percentage of difference | Standard Deviation 10.58 |
Secondary
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System, Using One Additional Calibration During FST
Enlite 3 Sensor accuracy using Guardian Mobile System compared to YSI or SMBG reference values, with one additional calibration during FST. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) \* 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose.
Time frame: 7 Days
Population: A total of 34 subjects did not have device data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enlite Sensor Accuracy MARD, Lower Serial Number | Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System, Using One Additional Calibration During FST | 10.05 percentage of difference | Standard Deviation 9.26 |
Secondary
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump
Enlite Sensor accuracy relative to the YSI reference. Each subject wore two 530G pumps. The results for the higher serial number pump worn by each subject were arbitrarily selected and pooled across subjects for the secondary dataset. 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 testing days were pooled together for reporting purpose.
Time frame: 6 Days
Population: All subjects wearing Enlite sensors with high serial number 530G pump. A total of 35 subjects did not have device data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enlite Sensor Accuracy MARD, Lower Serial Number | Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump | 17.50 percentage of difference | Standard Deviation 19.7 |
Secondary
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump, Using One Additional Calibration During FST
Enlite Sensor accuracy relative to the YSI reference, using one additional calibration during FST. 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 testing days were pooled together for reporting purpose.
Time frame: 6 Days
Population: A total of 34 subjects did not have device data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enlite Sensor Accuracy MARD, Lower Serial Number | Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump, Using One Additional Calibration During FST | 16.94 percentage of difference | Standard Deviation 18.74 |
Secondary
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump, Using One Additional Calibration During FST
Enlite Sensor accuracy relative to the YSI reference, using one additional calibration during FST. 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 testing days were pooled together for reporting purpose.
Time frame: 6 Days
Population: A total of 32 subjects did not have device data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enlite Sensor Accuracy MARD, Lower Serial Number | Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump, Using One Additional Calibration During FST | 14.37 percentage of difference | Standard Deviation 12.99 |