Effectiveness and Safety Study of the Next-Generation DexCom™ SEVEN® Continuous Glucose Monitoring System

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

• Registration Number: NCT00722241
• Lead Sponsor: DexCom, Inc.

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the next-generation DexCom SEVEN Continuous Glucose Monitoring System (SEVEN.2 System) when worn for up to 7-days by subjects \>18 years-old with diabetes mellitus requiring insulin therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2008-06
• Status Verified: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-24
• Last Update Submitted: 2008-07-24
• Study First Posted: 2008-07-25
• Last Update Posted: 2008-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Age 18 years or older
• Have been diagnosed with insulin-requiring diabetes and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy
• Willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the Sensor site during Sensor wear
• Willing to use only the blood glucose meter(s) provided to them for self-monitoring of blood glucose (SMBG) during Sensor wear
• Willing to participate in one, 8-hour in-clinic session and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the entire 8-hour duration
• Willing to take a minimum of 6 fingersticks per day during home use (2 for calibration purposes, 4 for comparative purposes)
• Willing to refrain from the use of acetaminophen during the Sensor insertion period and for at least 24-hours prior to Sensor insertion
• Willing not to schedule a magnetic resonance (MRI) scan, computed tomography (CT) scan, or x-ray, for the duration of the study
• Able to speak, read, and write English

Exclusion Criteria

• Have extensive skin changes/diseases that preclude wearing the Sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites
• Subjects who have a known allergy to medical-grade adhesives
• Are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion
• Have a hematocrit that is less than 30%, or greater than 55%
• Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study)
• Have any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis B or C)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SEVEN.2 System accuracy as compared to Yellow Springs Instrument (YSI) venous blood glucose measurements	Days 1, 4, and 7 of Sensor wear

Trial Locations

Locations (3)

John Muir Physician Network Clinical Research Center; 🇺🇸 Concord, California, United States

Advanced Metabolic Care + Research; 🇺🇸 Escondido, California, United States

Sansum Diabetes Research Institute; 🇺🇸 Santa Barbara, California, United States