Three-day, In-clinic Evaluation of the BD 2nd Generation Continuous Glucose Sensor Device in Type 1 Diabetics
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01645696|
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : April 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Device: BD CGM with Outer Layer Device: BD CGM without Outer Layer Device: Medtronic iPro2 Professional CGM||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Three-day, In-clinic, Clamp Evaluation of the BD 2nd Generation Continuous Glucose Sensor in Subjects With Type 1 Diabetes|
|Study Start Date :||June 2012|
|Primary Completion Date :||September 2012|
|Study Completion Date :||September 2012|
Experimental: BD Continuous Glucose Monitor (CGM) with outer layer
A subcutaneous glucose binding protein sensing device to continuously monitor glucose in diabetics.
Device: BD CGM with Outer Layer
continuous (every 2 minutes) subcutaneous glucose monitoring for 72 hours.
Experimental: BD CGM without outer layer
A continuous glucose binding protein sensing device used to monitor glucose in Diabetics
Device: BD CGM without Outer Layer
continuous (every 2 minutes) subcutaneous glucose monitoring over 72 hours.
Active Comparator: Medtronic iPro 2 Professional CGM
Commercial glucose oxidase continuous glucose monitor
Device: Medtronic iPro2 Professional CGM
continuous subcutaneous glucose monitoring for 72 hours
- Blood Glucose [ Time Frame: 72 hours ]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 characteristics to include warm up behavior, lag time and accuracy over 72 hours
- Number of participants with adverse events [ Time Frame: up to 89 days or until the subject is discharged ]At each study contact, subjects will be questioned about any adverse events that may have occurred
- Skin Effects-Draize Scoring for Skin Irritation [ Time Frame: Up to 36 days ]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.
- Skin thickness using ultrasound [ Time Frame: Upon removal of the devices ]Skin thickness will be measured at the sensor sites and a control site (on the abdomen) immediately after removal of the device.
- Insulin levels [ Time Frame: 72 hours ]Blood samples will be taken at pre-determined times following insulin dosings to test for insulin levels:
- antibodies against the glucose binding protein [ Time Frame: 36 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645696
|>LMC Endocrinology Centre, Clinical Research Unit|
|Toronto, Ontario, Canada, M4G 3E8|
|Principal Investigator:||Ronnie Aronson, MD||LMC Endocrinology Centre, Clinical Research Unit|