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Presenter: B., Elliott, Auckland, New Zealand
Authors: B. Elliott
Microencapsulated neonatal porcine islet implants alleviate unaware hypoglycaemia without immune suppression
B. Elliott
LCT, Auckland, New Zealand
Unaware hypoglycaemia occurs in up to 20% of Type 1 diabetics and may be responsible for 8% of deaths in this group. It has been shown that partial restoration of insulin production by human islet intra-hepatic transplantation with immune-suppression can restore awareness. We describe the effects of porcine islet implantation without immune-suppression on this important iatrogenic complication of the disease. Alginate/polyornithine/alginate microencapsulated neonatal porcine islets were implanted into the peritoneal cavity of 14 adult Type 1 diabetic patients with unstable diabetes, after a two month pre-implant intensified treatment and observation. The trial was approved by the relevant ethical and scientific bodies in New Zealand. The dose of islets was escalated from 5.000/kg to 20,000/kg. Diabetes control was assessed by 7/day blood glucose determinations with intermittent periods of continuous glucose monitoring, and HbA1c measurements and a standardized record of hypoglycaemic episodes. Daily insulin requirements were recorded as daily average/week. Insulin measured by a validated quantitative HPLC method specific for porcine insulin. In addition pre and post transplant counter-regulatory hormonal responses to a standardized insulin induced hypoglycaemic episode were measured. Average results to date over a year are shown for the lower dosed patients shown below. Most notable is the dramatic reduction in unaware hypoglycaemia despite only modest reduction in insulin dose and little change in high blood glucose related data.
Parameters |
Pre Tx |
Post- Tx Up to Week 12 |
Up to Week 12 - 52 |
Insulin Dose Weekly Average |
41 |
36 |
30 |
Hypo Score (Weekly Average - Severity Indicator) |
20 |
12 |
8 |
Number of Unaware Hypos (Weekly Average) |
3.2 |
1.5 |
0.8 |
HbA1c (%) |
7.5 |
7.5 |
7.6 |
Blood GLucose in Euglycaemic Range (% of time) |
57 |
57 |
58 |
This low dose islet xenotransplantation procedure without immune suppression appears to be effective in alleviating unaware hypoglycaemia, despite only modest reduction in insulin dose.
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