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June 24, 2006

Insulin Pumps, Research: Monitoring

Question from [email protected]:

My eight year old daughter was diagnosed with type 1 diabetes at 12 months old. She has been using a MiniMed insulin pump for five years. We have the opportunity to try the MiniMed Paradigm� REAL-Time Insulin Pump and Continuous Glucose Monitoring System. I know it has only been approved for people over age 18 in the U.S. What should my concerns be? What would you suggest?

Answer:

I do not know nuances of Israeli laws, etc. I presume you have spoken with your pediatric endocrinologist. Are you not satisfied with the responses? If you have not talked about your concerns, then that would be the first place.

I am not really certain what your are asking. A drug or device “not approved” for a child is not necessarily the same thing that the device or drug is “dis-approved;” rather, it means, typically, that the company or manufacturer has not supplied the reviewing agency any data to review as to effectiveness, safety, etc. for the device. If the device has only been tested in patients over the age of 18, the U.S. FDA will not typically approve for patients LESS than 18. If the company has done testing in under 18 year olds, but has not submitted those results for review, the FDA has nothing to review.

So, one of the concerns in the U.S. would be lack of insurance payment for “non-standard” or non-approved therapy.

The concepts are terrific and likely the wave of the future. It will not yet replace the need for glucose checks by poking.

DS