FDA approves software that determines drug dosages of insulin

May 14 2004

The FDA has approved a software suite developed by Dimensional Dosing Systems, Inc. for determining optimum drug dosages of insulin and many other drugs as well as combinations of drugs.

Using only two dose and response inputs the IDS reduces the risks of potentially dangerous side effects inherent in traditional trial and error methods.

The Intelligent Dosing System (IDS) incorporates patient specific, dosing data into a proprietary model that then calculates the optimal dose needed to achieve the desired target level or goal, according to John McMichael, the company CEO.

In a two year study conducted of more that 260 patients through the Grady Health System's Diabetes Clinic, a teaching affiliate of Emory University in Atlanta, GA, the IDS was placed on hand held PDA's and provided to practitioners to use in adjusting total daily insulin dose.

Fasting glucose, random glucose, and hemoglobin A1c were used as markers against which insulin could be adjusted.

Values of markers expected at the next follow-up visit, as predicted by the model, were compared to levels actually observed with excellent correlation.

Dr. Curtiss Cook, the principle investigator on this study concludes, "These analyses suggest the IDS is a useful adjunct for decisions regarding insulin therapy even when using a variety of markers of glucose control, and can be used by practitioners to assist in attainment of glycemic goals."

The results of this study have been accepted for publication in Diabetes Technology and Therapeutics in June of this year. Dr. David Klonoff the editor-in-chief of Diabetes Technology and Therapeutics writes, "Your group is conducting important research about insulin dosing technology that could help lead to development of an artificial pancreas."

Further studies are being planned to evaluate a new, web-based IDS that simultaneously adjusts insulin, oral agents, diet and exercise. For additional information visit http://www.3ddosing.com