On the plane yesterday I felt a tickle in my mind — prickly skin, a feeling of greater alertness, a touch of fear. Could my blood sugar be dropping? A quick check, and I find it is 78. My hypoglycemia awareness kicked in exactly as my blood sugar passed through 80 on the way down. A few M&Ms and the fear went away in a few minutes.
If I had not learned about my sugar drop, and done nothing, eventually I might have woken up in an emergency room.
Living Cell Technologies has announced that all of the patients who have received DIABECELL encapsulated pig islets in New Zealand have experienced a complete cessation of hypoglycemia unawareness. Most diabetics would like encapsulated islets to normalize blood sugar without any injected insulin. LCT has some treated patients off insulin but not all. So how important is this interim achievement of restoring hypoglycemia unawareness?
In a word, very important.
According to a National Surveillance Study, 8% of emergency room visits in the US (about 50,000) are caused by insulin and are therefore mostly low blood sugar. Serious blood sugar lows are much more frequent. The Edmonton Protocol targeted type 1 diabetics with hypoglycemia unawareness. The idea is that the side effects of chronic immune suppression are justified when they prevent potentially fatal hypoglycemia.
Hypoglycemia unawareness can result in prolonged exposure to hypoglycemia, resulting in a seizure, loss of consciousness, or brain damage. Hypoglycemia unawareness also makes good blood glucose control more difficult and puts increases risk for severe hypoglycemia-related complications.
LCT is increasing the dose of encapsulated islets in the hope that injected insulin requirements can be reduced further. For a diabetic, a reduced insulin requirement is a lot like revisiting the ‘honeymoon’, the period just after diagnosis when residual islet function makes controlling blood sugar much easier.
So in my opinion LCT has a winning product for people with type 1 diabetes who suffer from hypoglycemia unawareness. Hopefully their next study will produce even better results.
The ‘therapeutic window,’ that is, the gap between the intended effect and the undesired side-effect of a treatment, is narrower in intensively-controlled diabetes than in any other area of medicine, since the therapeutic target, normoglycemia, borders directly on the negative side-effect, which is hypoglycemia. This means that the actual ‘disease’ of diabetes, as it most commonly appears today in practice, is not really a disease of hyperglycemia so much as a disease of variable glycemia, yet clinicians persist in treating it as though the only focus of therapy ought to be reducing hyperglycemia. This then raises the question of what new specialty of physicians will arise to treat the typical form of the disease which, after initial diagnosis, continues to harm the patients’ health and quality of life, which is variable glycemia rather than hyperglycemia. This variable glycemia produces what is essentially not a glucose disorder but a seizure disorder of intensively mangaged type 1 diabetes marked by severe episodes of hypoglycemia. But while medicine normally regards generalized seizure disorders as representing such a severe reduction in patients’ quality of life that it is prepared to limit those disorders by severing the corpus callosum, with all the side-effects of this drastic procedure, for some reason medicine remains unwilling to moderate its strict blood sugar control recommendations, with whatever side-effects more that more relaxed regimen might bring, to cure the seizure disorder of repeated diabetic hypoglycemia.
If encapsulated porcine islets were marketed to cure just this problem, they would certainly represent a major medical advance, since 2% to 4% of all deaths in type 1 diabetics result from hypoglycemia. (Department of Health and Human Services, “Hypoglycemia in Patients with Type 1 Diabetes,” August 14, 2003 Bulletin, RFA-DIC-03-017) The old ‘magical thinking,’ which posited that patients could achieve normalization of blood glucose while avoiding hypoglycemic episodes, has been disproved with the discovery that intensively-controlled diabetes triples the number of hypoglycemic episodes which are so severe that they require help from other people, so if clinicians still choose to insist on lower HbA1c values, then the urgency for addressing this newly-identified iatrogenic ‘hypoglycemia disorder’ becomes acute. (L. Perlmutter, et al, “Glycemic Control and Hypoglycemia,” Diabetes Care, vol. 31, p. 2072 (2008))