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

Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925080
• Other study ID #: PTL-900193, Rev01
• Status: Completed
• Phase: N/A
• First received: June 17, 2009
• Last updated: February 2, 2010
• Start date: June 2009
• Est. completion date: August 2009

Study information

• Verified date: February 2010
• Source: DexCom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia

Intervention

Device:
• IVBG
Venous blood glucose measurement every 7.5 minutes for 72-hours

Locations

Country	Name	City	State
United States	Profil Institute for Clinical Research	Chula Vista	California
United States	Advanced Metabolic Care + Research	Escondido	California
United States	Diabetes and Glandular Disease Research Associates, Inc.	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		72-hours	No