Sept. 9 Forum Outlines Proposed Mandatory Surveillance Program of Blood Glucose Monitors; Patients Call for Greater FDA Enforcement
BETHESDA, Md., Sept. 10, 2013 /PRNewswire-USNewswire/ -- The Diabetes Hands Foundation commends the Diabetes Technology Society (DTS) for its proposed plan to develop a post-market surveillance system to ensure the accuracy and quality of self-monitoring of blood glucose (SMBG) systems. The proposed mandatory surveillance program was outlined at a Sept. 9 DTS forum in Bethesda, Md., to address growing concerns about ensuring the safety of people with diabetes who rely on SMBG systems to properly dose their insulin. The forum included perspectives from the U.S. Food and Drug Administration (FDA) – strong proponents of post-market surveillance – clinical chemists, physicians, device manufacturers and patient advocates.
"The Diabetes Hands Foundation believes a mandatory post-market surveillance program is a good first step toward improving blood glucose system accuracy, but will take time," said Manny Hernandez, Co-Founder and President of the Diabetes Hands Foundation. "In the interim, however, patients need additional protections. We look forward to working with FDA and DTS to identify effective near-term solutions."
At the forum, Diabetes Hands Foundation representative Bennet Dunlap articulated the need for patient awareness of the inaccuracy issue and greater enforcement on the part of the FDA.
Dunlap, along with the Diabetes Hands Foundation and others in the online community, created the StripSafely campaign to educate patients and caregivers about the inaccuracy issue, and urge regulators and Congress to take notice and action. Since June, participants have sent letters to Congress and more than 3,400 tweets have been issued under the StripSafely hashtag (#stripsafely) garnering attention from patients, industry and leaders in Washington.
StripSafely and the Diabetes Hands Foundation have a YouTube channel where patients can share their feelings about inaccurate meter readings and what that means for their care.
To learn more about the StripSafely campaign and how to get involved, visit www.StripSafely.com/join.
About Diabetes Hands Foundation
Diabetes Hands Foundation (www.DiabetesHandsFoundation.org) seeks to bring together people touched by diabetes for positive change so that nobody living with this condition ever feels alone. Through its Diabetes Advocates program, Diabetes Hands Foundation connects advocates dedicated to improving the lives of people living with diabetes in order to accelerate and amplify their efforts.
StripSafely (www.StripSafely.com) is collaboration of the Diabetes Online Community (DOC) to call on Congress and the FDA to remove inaccurate blood glucose test strips from the U.S. market. The StripSafely campaign was created by Bennet Dunlap with support from the Diabetes Hands Foundation and DOC leaders Scott Johnson, Christel Marchand Aprigliano, Kerri Sparling, Cherise Shockley, and Kelly Close. StripSafely encourages community members to write letters, blog posts, and post social media content to the FDA, elected officials, and the news media to encourage action to address the issue of inaccurate blood glucose test strips. The campaign is not affiliated with strip manufacturers, the FDA or any other remotely organized group.
SOURCE Diabetes Hands Foundation