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

This study has been completed.
Sponsor:
Information provided by:
DexCom, Inc.
ClinicalTrials.gov Identifier:
NCT00925080
First received: June 17, 2009
Last updated: February 2, 2010
Last verified: February 2010
  Purpose

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 Intervention
Diabetes
Hyperglycemia
Device: IVBG

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by DexCom, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2009
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Device: IVBG
Venous blood glucose measurement every 7.5 minutes for 72-hours

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals with insulin-requiring diabetes mellitus

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925080

Locations
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.
  More Information

No publications provided

Responsible Party: Andrew K. Balo / SVP, Clinical and Regulatory Affairs, and Quality Assurance, DexCom, Inc.
ClinicalTrials.gov Identifier: NCT00925080     History of Changes
Other Study ID Numbers: PTL-900193, Rev01
Study First Received: June 17, 2009
Last Updated: February 2, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014