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

This study has been completed.
Sponsor:
Information provided by:
DexCom, Inc.
ClinicalTrials.gov Identifier:
NCT00722241
First received: July 23, 2008
Last updated: July 24, 2008
Last verified: July 2008

July 23, 2008
July 24, 2008
May 2008
June 2008   (final data collection date for primary outcome measure)
SEVEN.2 System accuracy as compared to Yellow Springs Instrument (YSI) venous blood glucose measurements [ Time Frame: Days 1, 4, and 7 of Sensor wear ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00722241 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effectiveness and Safety Study of the Next-Generation DexCom™ SEVEN® Continuous Glucose Monitoring System
Effectiveness and Safety Study of the Next-Generation DexCom™ SEVEN® Continuous Glucose Monitoring System

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Ambulatory (non-hospitalized) individuals with type 1 diabetes or insulin-treated type 2 diabetes selected from endocrinology clinics within the United States

  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Not Provided
A
Adult subjects (at least 18 years of age) with a diagnosis of type 1 diabetes (~80%) or insulin-treated type 2 diabetes (~20%); method of insulin delivery may be multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
July 2008
June 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00722241
PTL-300012, Rev01
No
Andrew K. Balo / SVP, Clinical and Regulatory Affairs, and Quality Assurance, DexCom, Inc.
DexCom, Inc.
Not Provided
Study Chair: Andrew K Balo, BS DexCom, Inc.
DexCom, Inc.
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP