From: JLewis2326@cs.com
Sent: Thursday, April 15, 2004 12:31 PM
To: FDADockets@oc.fda.gov
Subject: Docket no 2004N-0086
FDA/National Institutes of Health Joint Symposium on Diabetes: Targeting Safe and Effective Prevention and Treatment. Docket No. 2004N-0086 

As a Certified Diabetes Educator and Past President of the American Association of Diabetes Educators, I am pleased that the FDA holding Public Meetings on the Prevention and Treatment of Diabetes. I know that the Diabetes Community is eager to be heard on the needs of our patients and prospective patients. This is a great opportunity for the Federal Government and its departments to hear from the people who are the experts in the field of diabetes prevention and care. 

I am unable to attend the meeting in May because of a prior commitment but would like this opportunity to make some suggestions before the meeting, rather than commenting afterwards. 

We have an opportunity to set aggressive goals and objectives to protect and care for the American public before the "Epidemic" of diabetes reaches such proportions that the needs would out way our resources both in qualified health care professionals or financial support. Ten years ago we told the Congress, in our lobbying campaign, that teaching patients to care for their diabetes with self management education and home blood glucose monitoring would make a major impact in the future numbers of people with diabetes and the quality of care people received. It was not until 1998 that funding became available and restrictions still impacted on the number of people we could help. 
Restrictions have now been lifted for many patients and for some it is too late. I think we have an opportunity to impact on care now and avoid the mistakes of the past. 

The next steps must be aggressive care, early and quickly and it must be done by competent people. I urge support of legislation that approves Medicare reimbursement for Diabetes Education by Certified Diabetes Educators. HR  3194 proposes this approval. 

Care must be given to people who have diabetes now and those who will develop diabetes in the near future. We cannot commit to care for one level of diabetes and not all levels or categories. Waiting until blood sugar levels are consistent with complications makes no sense and is certainly not cost effective. 

I would suggest that the diabetes community will make an excellent case for aggressive treatment and prevention methodologies and I request that delays and bureaucracy not postpone the opportunity the FDA, NIH and CDC have to be proactive in this issue. Action now will prevent hearing in the future on how to deal with an out of control crisis. 

As and Educator and Consultant I offer all my support to this process. 

Respectfully submitted, 


Ginger Kanzer-Lewis RN, BC, EdM, CDE 
GKL Associates 
PO Box 500790 
Marathon FL. 33050 
gingerk@csi.com 
305-304-2142