After consulting your database regarding the advances in the treatment and in the quest for a cure for diabetes, I have a number of questions:

Is there updated information on the status of development of an indwelling glucose sensor integrated to an insulin pump? Is this already under FDA approval? If so, what phase? If not, what is the present development stage, within what time frame this could be expected? What are the main difficulties involved in its commercial release?
Have you any news on the SugarTrac, a non-invasive glucose meter which was in development?
Have you updated information on the FDA approval of inhaled insulin? When is it supposed to be commercially available?
From answers dated approximately one year ago, I had the impression that you were not much confident about the possibilities of INGAP-Peptide. Now that FDA phase I is apparently finished, has anything changed that made you more confident about its possibilities?

At the 2003 Diabetes Technology Meeting, many companies presented information about continuous sensors that could, in theory, be coupled with an insulin pump once the sensors are proven in clinical trials. Sensor accuracy and lifespan remain limiting factors in the potential effectiveness of such a system. Based on some data presented, several companies have products that look promising but remain to be proven in widespread clinical trials. Key participants in the conference felt that such a system, perhaps still requiring user intervention at certain times, would be available for clinical use in about six years.

JSH
Additional comments from Dr. Donough O’Brien:

Progress in the search for a ‘cure’ for type�1 diabetes is slow but nonetheless sure. Probably the most advanced systems for the present are the insulin pumps that are linked to meters. They can calculate a bolus amounts, but of course do not implement it until instructed. It is however at present only available in the U.S. No one yet has an approved sensor system that safely and accurately controls a pump., and it is likely to be at least three or four years before it is FDA approved.

SugarTrac is an ingenious and completely non invasive infra-red based sytsem which, as far as I can tell has not yet started on the long drawn out approval process. Its appeal is likely to be to those who do not use a pump.

In addition to inhaled insulin, there is a conjugated insulin that can penetrate the buccal mucosa. Preliminary trials have shown that Oralin which is supplied in a device rather like an asthma inhaler gives good control when used with a single daily injection of a long acting insulin like Lantus. Again, Oralin is not yet FDA approved. The disadvantages are that it is at best only 25% efficient in comparison to injected insulin and that its onset of action is a little slower than Humalog so that it may be less easy to adjust the dose to the pre-meal blood sugar and ‘carbs ‘ actually consumed. Dosage for small children will inevitably be a little less precise.

I was not aware that clinical trials of INGAP had begun in subjects with type�1A (autoimmune) diabetes. Some very recent work has shown that in the late stages of prediabetes there is evidence of islet regeneration from the pancreatic ducts but that ultimately these islets do not survive the continuing autoimmune process. Nonetheless, this is field that is being extensively investigated and when combined with new ways of circumventing autoimmunity and other factors in islet regeneration may have a role in treating type�1 diabetes, but it is at least a decade away. My own prediction is that advances in islet cell transplant technology will offer the most available hope after progress in closed loop pumps.

DOB