Diabetes
Conditions
Keywords
blood sugar, glucose, sensor
Brief summary
The purpose of this study is to assess the performance of the subcutaneous glucose sensor over an extended sensor life. The sensor is currently approved for 3 days of use and this study will examine sensor safety and accuracy when used for six days. This study will also test sensor safety and accuracy when inserted in an alternate body location (buttock area in addition to abdomen area). The study hypothesis is that the sensor performance will not greatly diminish when used for six days, or in an alternate insertion area.
Detailed description
The Medtronic MiniMed Subcutaneous Glucose 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 is used as part of the Guardian REAL-Time System, the latest advance in continuous glucose monitoring, which is based on the CGMS. Similar to the CGMS, the Guardian REAL-Time System has been developed for use in conjunction with a standard home blood glucose meter. The Guardian REAL-Time received regulatory approval from the FDA in 2006. As currently used, the Subcutaneous Glucose Sensor is labeled for a maximum use duration of 72 hours, using only the abdomen area as an insertion site. Recent studies have shown that the useful sensor life could extend beyond three days, and it is reasonable to expect a significant percentage of sensors to last six days. It is the goal of this study to confirm sensor performance accuracy data from one of these recent studies. The sensor is also commonly worn in body areas other than the abdomen (such as the buttock). This study will also demonstrate sensor accuracy when used in an alternate site.
Interventions
DEVICEMMT-7003 subcutaneous glucose sensor
All subjects will use the glucose sensor, randomized to participate in a 12-hour frequent (15-minute) blood glucose sampling period on one of six days of sensor wear. Blood samples will be analyzed using a laboratory standard (YSI) for comparison to the glucose sensor to evaluate accuracy.
Sponsors
Medtronic Diabetes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males and females aged 18 through 75 inclusive * Type 1 Diabetes Mellitus treated using either CSII (continuous subcutaneous insulin infusion) or MDI (multiple daily injections) for a minimum of 3 months * Willingness to perform required study and data collection procedures and adhere to operating requirements of the Guardian REAL-Time and CGMS iPro Systems * Willingness to perform at least 4 capillary blood glucose tests per day while wearing the Guardian REAL-Time and iPro Systems * Willing to participate in a 12 hour frequent blood sampling session during the study * Subject agrees to comply with the study protocol requirements * Informed Consent, HIPAA Authorization, and California Experimental Subject Bill of Rights (if applicable) signed by the subject * The Subject is willing to wear both the Guardian REAL-Time and CGMS iPro Systems for 6 days (\ 144 hours).
Exclusion criteria
* The Subject has a history of tape allergies that have not been resolved * The Subject has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) that has not been resolved and would inhibit them from wearing the sensors * Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the Subject from completing the study * Subject is currently participating in an investigational study (drug or device)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI-Yellow Springs Instruments) | Days one through six of sensor use | The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI \<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 |
|---|---|
| Subcutaneous Sensor Group All subjects wore subcutaneous sensors | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Subcutaneous Sensor Group |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants |
| Age Continuous | 38.7 years STANDARD_DEVIATION 13.71 |
| Region of Enrollment United States | 63 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 63 |
| serious Total, serious adverse events | 0 / 63 |
Outcome results
Primary
Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI-Yellow Springs Instruments)
The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI \<80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.
Time frame: Days one through six of sensor use
Population: 61 subjects of 63 enrolled subjects (a total of 4971 paired YSI and sensor readings) completed participation in the inpatient frequent blood sampling procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Completed Subjects | Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI-Yellow Springs Instruments) | 75.45 paired YSI/sensor glucose values |
p-value: <0.0595% CI: [60, 100]ANCOVA
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 (NUMBER) |
|---|---|---|
| All Completed Subjects | Device Related Moderate or Device Related Severe Adverse Events | 0 events |