NCT01645696

Three-day, In-clinic Evaluation of the BD 2nd Generation Continuous Glucose Sensor Device in Type 1 Diabetics

Three-day, In-clinic, Clamp Evaluation of the BD 2nd Generation Continuous Glucose Sensor in Subjects With Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	BD CGM with Outer Layer	continuous (every 2 minutes) subcutaneous glucose monitoring for 72 hours.
DEVICE	BD CGM without Outer Layer	continuous (every 2 minutes) subcutaneous glucose monitoring over 72 hours.
DEVICE	Medtronic iPro2 Professional CGM	continuous subcutaneous glucose monitoring for 72 hours

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-07-20
• Last updated: 2021-12-29

Locations

1 site across 1 country: Canada