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

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: NCT00925080
Recruitment Status : Completed
First Posted : June 19, 2009
Last Update Posted : February 3, 2010
Information provided by:
DexCom, Inc.

Brief 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).

Condition or disease Intervention/treatment
Diabetes Hyperglycemia Device: IVBG

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : June 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Group/Cohort Intervention/treatment
A Device: IVBG
Venous blood glucose measurement every 7.5 minutes for 72-hours

Primary Outcome Measures :
  1. 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). [ Time Frame: 72-hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with insulin-requiring diabetes mellitus

Inclusion Criteria:

  1. Age 18 years or older;
  2. Willing to participate in one 72-hour in-clinic session during which up to 72 venous blood samples drawn for YSI measurement of glucose concentration (maximum sampling frequency of 4 per hour), a fingerstick blood glucose measurement will also be performed at the time of each YSI blood draw;
  3. If instructed, be willing not to perform any activities that would result in submersion of the Sensor/Potentiostat in water or willing to wear a waterproof covering when submerging the Sensor/Potentiostat;
  4. Have been diagnosed with insulin-requiring diabetes mellitus and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
  5. Able to speak, read, and write English.

Exclusion Criteria:

  1. Have skin conditions or existing (or planned) medical instrumentation and/or dressings that preclude wearing the IVBG Sensor (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis, or surgical dressings at the proposed wear site);
  2. Are pregnant (as demonstrated by a positive pregnancy test within 72-hours of device insertion);
  3. Have a contraindication to placement of a dedicated peripheral IV line;
  4. Have a known history of heparin-induced thrombocytopenia;
  5. 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);
  6. 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): NCT00925080

United States, California
Profil Institute for Clinical Research
Chula Vista, California, United States, 91911
Advanced Metabolic Care + Research
Escondido, California, United States, 92026
United States, Texas
Diabetes and Glandular Disease Research Associates, Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
DexCom, Inc.

Responsible Party: Andrew K. Balo / SVP, Clinical and Regulatory Affairs, and Quality Assurance, DexCom, Inc. Identifier: NCT00925080     History of Changes
Other Study ID Numbers: PTL-900193, Rev01
First Posted: June 19, 2009    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases