CDRH Background Package

 

 

Clinical Chemistry and Clinical Toxicology Devices Panel Meeting

October 29, 2001

 

 

 

 

 

CONTENTS

 

  1. Nature of the Problem
  2. Draft Agenda
  3. Draft FDA Questions
  4. Questions provided to AdvaMed to help sponsors prepare presentations
  5. Literature Articles

 

 

Nature of the Problem

 

Until a few years ago, only blood samples taken from the fingertip were recommended for use with glucose meters. In the past few years, however, certain glucose meters have been cleared for marketing that allow for diabetics to use blood samples collected from alternate sites, such as the forearm, upper arm, thigh, or base of the thumb. Blood glucose measurements at these sites correlate well with fingertip readings during periods when glucose levels are stable.1-2

More recent studies that have examined the relative measurements between fingertip and alternate site samples observed that blood glucose levels from alternate sites may lag behind those taken from the fingertip.3-5 For example, a patient with hypoglycemic unawareness was measured with an alternate site reading of 142 mg/dl, in the mildly hyperglycemic range, while the fingertip reading was measured at 51 mg/dl, in the hypoglycemic range.3

One study reported that rubbing the collection site prior to puncture may decrease the differences between fingertip and alternate site readings.5 At present, there is insufficient information to fully evaluate the effectiveness of this practice.

FDA is convening a meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel on October 29, 2001 to address concerns related to blood glucose monitoring at alternate sites. The panel meeting will include presentations from the FDA, industry, and other stakeholders.

References

  1. Fineberg SE, Berganstal RM, Bernstein RM, et al: Use of an automated device for alternative site blood glucose monitoring. Diabetes Care 24:1217-1220, 2001.
  2. Cunningham DD, Henning TP, Shain EB, et al: Vacuum-assisted lancing of the forearm: an effective and less painful approach to blood glucose monitoring. Diabetes Technol Ther Winter; 2(4):541-8, 2000.
  3. Jungheim K and Koschinsky T: Risky delay of hypoglycemia detection by glucose monitoring at the arm. Diabetes Care 24:1303-1304, 2001.
  4. Ellison J, Stegmann J, Colner S, et al: Arm and thigh capillary blood glucose as an alternative to fingertip sampling in the management of diabetes. 61st Annual Meeting and Scientific Sessions, American Diabetes Association, June 22-26, 2001, Philadelphia, Pennsylvania.
  5. McGarraugh G, Schwartz S and Weinstein R: Glucose Measurements using blood extracted from the forearm and the finger. Diabetes Care 24:1304-1306, 2001.

DRAFT

CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES PANEL MEETING

Gaithersburg Hilton, Salons A-D

October 29, 2001

Panel Chair: Martin H. Kroll, M.D.

Executive Secretary: Veronica J. Calvin, M.A.

Division Director: Steven I. Gutman, M.D., M.B.A.

Deputy Division Director: Donald J. St. Pierre

Branch Chief: Jean M. Cooper, M.S., D.V.M.

 

 

Agenda: The committee will provide advice and recommendations on the types of data and/or labeling needed in 510(k) submissions for glucose test systems to address problems associated with using blood samples from alternate sites, such as the forearm, upper arm, thigh, calf, or base of the thumb.

 

8 a.m. Call to Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Panel Chair

Opening Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Dr. Bernard Statland
Director, Office of Device Evaluation

Conflict of Interest Statement . . . . . . . . . . . . . . . . . . . . . . . .Executive Secretary

Introductions

8:15 a.m. FDA Presentation

8:45 a.m. Sponsors Presentations

10 a.m. Break

10:15 a.m. Sponsors Presentations

11 a.m. Open Public Hearing

Public attendees, who contacted the Executive Secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of glucose test systems.

12 p.m. Lunch

1:00 p.m. Open Committee Discussion

This portion of the meeting is open to public observers. Public observers may not participate except at the specific request of the Chairperson.

2:45 p.m. Break

3 p.m. Open Public Hearing

Public attendees, who contacted the Executive Secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of glucose test systems.

3:30 p.m. Open Committee Discussion

This portion of the meeting is open to public observers. Public observers may not participate except at the specific request of the Chairperson.

4:15 p.m. Final Panel Recommendations

4:30 p.m. Closing Remarks

Adjourn . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Panel Chair

Clinical Chemistry and Clinical Toxicology Devices Panel Meeting

October 29, 2001

DRAFT PANEL QUESTIONS

Questions Provided to AdvaMed

FDA generated the following questions to help the industry prepare for the October 29, 2001 Clinical Chemistry and Clinical Toxicology Devices Panel meeting.

  1. Does your company market any alternate site glucose testing system?
  2. Have you tested (evaluated) for physiological/equilibration concerns as part of the pre-analytic error?
  3. What was the nature of the study(ies) and what were the conclusions?
  4. Are there any unique aspects of your device that would increase or minimize these differences?
  5. How will you modify (or how have you modified) your labeling to address these issues?
  6. Specifically what advice do you recommend to the patients who would be using these devices?
  7. What additional studies need to be done?