The FDA says:

This is to alert you to the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars. These sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death. The following provides background information on this problem, a summary of fatality reports FDA has received, and recommendations to reduce the risk. This problem can occur wherever these products are used including in-patient and out-patient healthcare facilities, and at home.

This seems to be a recurring topic, here’s a FDA warning video from 2008:

Find full details here: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm

Here is a full list of to known affected Meters/Strips:

List of GDH-PQQ Glucose Test Strips
The following test strips (with associated meters) use GDH-PQQ methodology as of August 2009:
Roche Diagnostics:

• ACCU-CHEK Comfort Curve test strips, for use with:


• ACCU-CHEK Inform meters [model 2001201]


• ACCU-CHEK Complete meters [models 200 and 250]


• ACCU-CHEK Advantage meters [models 888, 831, 850, and 768]


• ACCU-CHEK Voicemate meters [model 0009221]


• ACCU-CHEK Aviva test strips, for use with:


• ACCU-CHEK Aviva meters [models 525, 535, and 555]


• ACCU-CHEK Compact test strips, for use with:


• ACCU-CHEK Compact meters [model GF]


• ACCU-CHEK Compact Plus meters [models GP and GT]


• ACCU-CHEK Go test strips


• ACCU-CHEK Go meters [model GJ]


• ACCU-CHEK Active test strips


• ACCU-CHEK Active meters [models GG and GN]

Abbott Diabetes Care:

• Freestyle test strips, for use with:


• FreeStyle meters


• FreeStyle Flash meters


• FreeStyle Freedom meters


• Freestyle Lite test strips, for use with:


• FreeStyle Lite meters


• FreeStyle Freedom Lite meters

Home Diagnostics:

TRUEtest test strips
TRUEresult meters
TRUE2go meters

Smiths Medical:

Abbott Diabetes Care Freestyle test strips, for use with:
CoZmonitor blood glucose module (for use with the Deltec Cozmo Insulin Pump)
Insulet:
Abbott Diabetes Care Freestyle test strips, for use with:
OmniPod Insulin Management System

You might have heard, but if not please go over to http://www.healthefda.com to get more info and sign this petition.

The FDA has its place for many things and I’m sure they have the best of intentions at heart. But they could be doing a whole lot better in regards to diabetes and new diabetic treatments. While safeguards and rules are important, they have such stringent restrictions it severely limits new and innovative options for diabetic patients.

We need to let the FDA to hear us and try and get some of the restrictions removed or changed, this petition in part tries to do that and more. We need 20,000 petitions by February, so PLEASE sign it in case you haven’t already and forward it to anyone you think would support the cause.

From the Website:

“We, the undersigned, appeal to the leadership of the U.S. Food and Drug Administration (FDA) to reduce barriers to innovation in diabetes treatment development, in the interest of public health.

The FDA’s job is to protect the safety of patients in its use of drugs and medical devices and to advance public health by speeding innovations that make medicines and technology more effective, safer and more affordable. That is its mission.

But we believe the FDA has adopted a stance of excessive caution in its regulation of diabetes drugs and technology that is counter to its duty to serve patient needs.

Specifically, it has established new rules that will impair research and innovation into diabetes therapy. (A copy of the letter sent to manufacturers in November 2008 can be found at www.diatribe.us/fdaletter.)

This worries us. For example, new requirements for additional multi-year long-term outcome studies prior to approval for drugs with no cardiovascular signals will assuredly discourage research and innovation to the detriment of public health.”

Around the Net

Here’s a message from our good friend Manny at TuDiabetes:

Read what others are saying about this:

• http://tudiabetes.com/forum/topics/help-promote-the-fda-petition
• http://www.bernardfarrell.com/blog/2009/01/ask-fda-to-better-serve-diabetes.htm


• http://www.diabetesmine.com/2009/01/the-diabetes-community-appeal-to-the-fda-dont-slam-the-door-on-progress.html

Petition Sponsors

Kelly Close: Editor, diaTribe
Manny Hernandez: President, Diabetes Hands Foundation; Founder, TuDiabetes
Amy Tenderich: Creator and Author, DiabetesMine
Nadia Al-Samarrie: Publisher, Diabetes Health magazine
Marston Alfred: Founder, SugarStats.com
Allison Blass: Author, Lemonade Life
Jennifer Block, CDE: Stanford Medical Center, Stanford University
Nancy Bohannon, MD: Director of Clinical Research, CVD Risk Reduction Program, St. Luke’s Hospital, San Francisco
Bruce Buckingham, MD: Professor of Pediatric Endocrinology, Stanford University
Stead Burwell: CEO, Alliance Health Networks, Inc.
Priscilla Call Essert: Author, My Life As A Pancreas
Gina Capone: Co-Founder, the Diabetes Talkfest Blog
Fran Carpentier: Author, Diabetes, Day-By-Day on Parade.com
Kitty Castellini: Founder, CEO, Producer and Host, Diabetes Living Today – Talk Radio
David Edelman: Co-Founder, Diabetes Daily
Steve Edelman, MD: Professor of Medicine, University of California, San Diego; Founder, Taking Control of Your Diabetes
Bernard Farrell: Author, the Diabetes Technology Blog
Bob Hawkinson: Author, Joy of Diabetes
James S. Hirsch: Author, Cheating Destiny
Irl B. Hirsch, MD: Professor of Medicine, University of Washington
Lois Jovanovic, MD: CEO and Chief Scientific Officer, Sansum Diabetes Research Institute
Francine R. Kaufman, MD: Professor of Pediatrics, Keck School of Medicine, USC; Head, Center for Diabetes, Endocrinology and Metabolism, Childrens Hospital Los Angeles; former ADA President
Tom Karlya: Author, Diabetes Dad
Rebecca Killion: Diabetes advocate
David Mendosa: Diabetes Journalist
Kerri Morrone Sparling: Author, Six Until Me
Jenny Ruhl: Author, Blood Sugar 101
Lisa Shenson: Diabetes Parent & AdvocateScott Strumello: Author, Scott’s Web Log
Howard Steinberg: CEO and Founder, dLife
Virginia Valentine: CNS, BC-ADM, CDE, CEO, Diabetes Network, Inc. Albuquerque, New Mexico

Sign it Now

You can even sign it now via the widget below: