The purpose of this study is to investigate the accuracy and performance of a new subcutaneous continuous glucose monitor (BD-CGM, Becton Dickinson) in hyperglycemic (high blood sugar) and hypoglycemic (low blood sugar) "clamp" conditions and during meal excursions over the course of 72 hours as compared to a commercially available monitor.
This is a single site, non-randomized study. The study consists of a Screening Visit (Visit 1) during which the subject will be consented and the inclusion exclusion criteria confirmed. An interventional visit (Visit 2)which consists of a 72 hour in-clinic stay and a Follow-up Visit (Visit 3). Subjects eligible for the study will be admitted to the clinic for the Study Visit 2 in the afternoon on the day before the first Clamp is performed. An IV line for blood sampling will be established. One blood sample will be obtained for glucose determination and a second blood sample will be collected for immunoassay development before any sensors are inserted. Two BD-Glucose Binding Protein-Continuous Glucose Monitor Sensors(BD-GBP-CGM), with and without outer layer, and one commercial CGM sensor will be inserted in the subcutaneous tissue in the abdomen shortly thereafter. Blood sampling intervals will be adjusted over the 3 study days as determined by the study event (i.e. clamp period, meal excursion, nighttime). During the hyper- /hypo-glycemic clamps periods on Day 1 and Day 3 blood samples will be taken more frequently, every 5-10 minutes. During the breakfast meal on Day 2 sampling will occur at 10-15 minute intervals for 4 hours to capture the meal excursion. Sampling will be less frequent during the evening meal and at night during sleep hours.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
30
continuous (every 2 minutes) subcutaneous glucose monitoring for 72 hours.
continuous (every 2 minutes) subcutaneous glucose monitoring over 72 hours.
continuous subcutaneous glucose monitoring for 72 hours
>LMC Endocrinology Centre, Clinical Research Unit
Toronto, Ontario, Canada
Blood Glucose
Blood glucose will be measured by the BD-Continuous Glucose Monitor, with and without outer layer, the commercially available Medtronic iPro2 and the YSI (Yellow Springs Instrument) Glucose analyzer (control) for 72 hours. Blood glucose will be used to determine performance of the device to include warm up behavior, lag time and accuracy of the blood glucose monitor over 72 hours.
Time frame: 72 hours
Number of participants with adverse events
At each study contact, subjects will be questioned about any adverse events that may have occurred and are potentially related to the device.
Time frame: up to 89 days or until the subject is discharged
Skin Effects-Draize Scoring for Skin Irritation
Local reaction at insertion sites will be scored for redness and swelling at the following timepoints: Visit 2-pre-insertion of devices, immediately post insertion of the devices, each morning of Day 1, 2 and 3, immediately after removal of the devices and at Visit 3.
Time frame: Up to 36 days
Skin thickness using ultrasound
Skin thickness will be measured at the sensor sites and a control site (on the abdomen) immediately after removal of the device.
Time frame: Upon removal of the devices
Insulin levels
Blood samples will be taken at pre-determined times following insulin dosings to test for insulin levels:
Time frame: 72 hours
antibodies against the glucose binding protein
A blood sample will be taken at the beginning of Visit 2 and at Visit 3 to test for antibody production following exposure to the sensor's glucose binding protein.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 36 days