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

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. Identifier: NCT00722241
Recruitment Status : Completed
First Posted : July 25, 2008
Last Update Posted : July 25, 2008
Information provided by:
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.

Condition or disease
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effectiveness and Safety Study of the Next-Generation DexCom™ SEVEN® Continuous Glucose Monitoring System
Study Start Date : May 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ambulatory (non-hospitalized) individuals with type 1 diabetes or insulin-treated type 2 diabetes selected from endocrinology clinics within the United States

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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00722241

United States, California
John Muir Physician Network Clinical Research Center
Concord, California, United States, 94520
Advanced Metabolic Care + Research
Escondido, California, United States, 92026
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
Sponsors and Collaborators
DexCom, Inc.
Study Chair: Andrew K Balo, BS DexCom, Inc.

Responsible Party: Andrew K. Balo / SVP, Clinical and Regulatory Affairs, and Quality Assurance, DexCom, Inc. Identifier: NCT00722241     History of Changes
Other Study ID Numbers: PTL-300012, Rev01
First Posted: July 25, 2008    Key Record Dates
Last Update Posted: July 25, 2008
Last Verified: July 2008

Keywords provided by DexCom, Inc.:
Continuous Glucose Monitoring
Interstitial Fluid
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases