Type 1 Diabetes Mellitus
Conditions
Keywords
diabetes, glucose, sensor
Brief summary
The purpose of this study is to assess performance of a new subcutaneous glucose sensor over a seven day sensor life when used with currently marketed Medtronic Diabetes devices. In addition performance of the new sensor will be calculated for use of the new sensor with proposed new devices using new calibration algorithms.
Detailed description
The first generation Medtronic MiniMed Subcutaneous Glucose Sensor (Sof-Sensor) was originally approved by the FDA for commercialization as part of the Continuous Glucose Monitoring System (CGMS) on June 15, 1999 (PMA 980022). The Sensor is composed of a microelectrode with a thin coating of glucose oxidase beneath several layers of biocompatible membrane. This same sensor was used as part of subsequent continuous glucose monitoring (CGM) systems, such as the Guardian REAL-Time and Paradigm REAL-Time sensor augmented insulin pump. The current configuration of sensor has undergone in vitro and in vivo testing. A new second-generation glucose sensor (herein referred to as the Comfort Sensor) has been developed. The first-generation glucose sensor was approved with reported sensor accuracy (MAD) of 18%; it was labeled for maximum use duration of 72 hours, using only the abdomen as an insertion site. The new sensor is shorter and has a smaller diameter, with a smaller gauge introducer needle. The new sensor inserter is designed to be used with the new sensor. The objectives of this study are to 1) Assess performance of the Comfort Sensor when used over a period of seven days with currently available devices, and 2) Assess performance of the Comfort Sensor when used over a period of seven days using new calibration algorithms (post-processed with algorithm for future devices). Accuracy data will be calculated based on comparing calibrated glucose sensor values to glucose meter values during in-home testing. The devices that will be used for gathering sensor data during this study will be: 1) the Comfort Sensor, 2) the MiniLink (Transmitter), and 3) the Guardian REAL-Time Display Device.
Interventions
DEVICESensor wear
All subjects to wear sensors
Sponsors
Medtronic Diabetes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females aged 7 through 17 inclusive 2. Diagnosed with Type 1 Diabetes Mellitus 3. Willingness to perform required study and data collection procedures and to adhere to operating requirements of the Guardian REAL-TIME System 4. Willingness to perform at least 4 capillary blood glucose tests per day while wearing the Guardian REAL-TIME System 5. Subject agrees to comply with the study protocol requirements 6. Informed Consent, Assent, HIPAA Authorization, and California Experimental Subject Bill of Rights (if applicable) signed by the subject and/or parent/guardian 7. The Subject is willing to wear the Guardian REAL-Time System for 14 days (\ 340 hours).
Exclusion criteria
1. The Subject has a history of tape allergies that have not been resolved at time of enrollment 2. The Subject has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) in the area of sensor placement that have not been resolved at the time of enrollment and would inhibit them from wearing the sensors 3. Subject has a positive pregnancy test on enrollment 4. Subject is currently participating in an investigational study (drug or device)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Sensor Accuracy When Compared to SMBG: Proportion of Glucose Sensor Readings That Met Accuracy Criteria [Time Frame: Days One Through Six of Sensor Use] | Days one through six of sensor use | The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and SMBG glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between SMBG and paired sensor (within 20 mg/dL if SMBG ≤ 80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Related Moderate or Device Related Severe Adverse Events | days one through six of sensor wear | Device related moderate adverse event: low level of inconvenience or concern to the subject and may interfere with daily activities but is usually improved by simple therapeutic remedy. Device related severe adverse event: interrupts a subject's daily activity and typically requires intervening treatment. Note: device related determination is made by the site that there is a reasonable possibility that the adverse event may have been caused by the device |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Wearing Sensors All subjects that wear sensors (all subjects)
Sensor wear: All subjects to wear sensors | 83 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Subjects Wearing Sensors |
|---|---|
| Age, Continuous | 12.5 years STANDARD_DEVIATION 2.8 |
| Region of Enrollment United States | 83 participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 83 |
| other Total, other adverse events | 0 / 83 |
| serious Total, serious adverse events | 0 / 83 |
Outcome results
Primary
Glucose Sensor Accuracy When Compared to SMBG: Proportion of Glucose Sensor Readings That Met Accuracy Criteria [Time Frame: Days One Through Six of Sensor Use]
The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and SMBG glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between SMBG and paired sensor (within 20 mg/dL if SMBG ≤ 80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.
Time frame: Days one through six of sensor use
Population: a total of 3496 paired sensor and SMBG readings were recorded
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Subjects Wearing Sensors | Glucose Sensor Accuracy When Compared to SMBG: Proportion of Glucose Sensor Readings That Met Accuracy Criteria [Time Frame: Days One Through Six of Sensor Use] | 72.4 % of paired SMBG/Sensor glucose values |
Secondary
Device Related Moderate or Device Related Severe Adverse Events
Device related moderate adverse event: low level of inconvenience or concern to the subject and may interfere with daily activities but is usually improved by simple therapeutic remedy. Device related severe adverse event: interrupts a subject's daily activity and typically requires intervening treatment. Note: device related determination is made by the site that there is a reasonable possibility that the adverse event may have been caused by the device
Time frame: days one through six of sensor wear
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects Wearing Sensors | Device Related Moderate or Device Related Severe Adverse Events | 0 Participants |