NCT00925080

Pivotal Study of the Intravenous Blood Glucose (IVBG) System, In-Clinic Setting

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: DexCom, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate safety and accuracy of the IVBG System (the "System") when used to track blood glucose in insulin treated subjects with diabetes mellitus in an in-clinic setting for up to 72 hours (per subject). Reference blood glucose measurements will be collected across the entire reportable range of the System (e.g., 40 400 mg/dL) with adequate sampling at the upper and lower ends of this range. IVBG System accuracy will primarily be assessed relative to ISO 15197 criteria (i.e., within ±15 mg/dL at YSI glucose levels \< 75 mg/dL, and within ±20% at YSI glucose levels \>75 mg/dL).

Conditions

• Diabetes
• Hyperglycemia

Interventions

Type	Name	Description
DEVICE	IVBG	Venous blood glucose measurement every 7.5 minutes for 72-hours

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-07-01
• Completion: 2009-08-01
• First posted: 2009-06-19
• Last updated: 2010-02-03

Locations

3 sites across 1 country: United States