When I was first diagnosed with diabetes, the Professor of Endocrinology from Harvard Medical School who was teaching new patients at the Joslin Clinic in Boston told us that strict blood sugar control would be very difficult to achieve, but we should do our best since âwithin five yearsâ an artificial pancreas would be available which would control glucose levels automatically, so we should try to prevent any damage developing until then. The problem was, that was in 1966, and I have been hearing the usual âfive to ten yearsâ cant ever since. If you gave medical science a diagram and a working model of a door knob, it would take ten to twenty thousand years for them to develop a way to open doors, since they are so glacially slow in their ability to make progress. Physics operates via decisive experiments which can change the field overnight, but in medicine no one believes anything until a few decades go by, and even after it has been abundantly proven to work, many people still oppose it. Here, even if everything goes perfectly, we are looking at 16 years to approval under the tyranny of the FDA (the foot-dragging administration).
Even if approved, the published results show this device will be far from perfect, since it does not provide full normalization of blood sugar levels and even still permits hypoglycemic episodes to occur. Also, we know that the complications are in part caused by genes inherited along with the genes that predispose people to develop the initial autoimmune attack on the pancreas which produces diabetes, and also by the continuing autoimmunity as it affects other parts of the body after the initial destruction of the pancreatic beta cells, so even perfect blood sugar control would not entirely prevent the complications from developing.
For the published results, see: Steven Russell, Edward Damiano, et al., âOutpatient Glycemic Control with a Bionic Pancreas in Type 1 Diabetes,â New England Journal of Medicine, 371: 313-325 (2014):
Results
Among the adults, the mean plasma glucose level over the 5-day bionic-pancreas period was 138 mg per deciliter (7.7 mmol per liter), and the mean percentage of time with a low glucose level (<70 mg per deciliter [3.9 mmol per liter]) was 4.8%. After 1 day of automatic adaptation by the bionic pancreas, the mean (±SD) glucose level on continuous monitoring was lower than the mean level during the control period (133±13 vs. 159±30 mg per deciliter [7.4±0.7 vs. 8.8±1.7 mmol per liter], P<0.001) and the percentage of time with a low glucose reading was lower (4.1% vs. 7.3%, P=0.01). Among the adolescents, the mean plasma glucose level was also lower during the bionic-pancreas period than during the control period (138±18 vs. 157±27 mg per deciliter [7.7±1.0 vs. 8.7±1.5 mmol per liter], P=0.004), but the percentage of time with a low plasma glucose reading was similar during the two periods (6.1% and 7.6%, respectively; P=0.23). The mean frequency of interventions for hypoglycemia among the adolescents was lower during the bionic-pancreas period than during the control period (one per 1.6 days vs. one per 0.8 days, P<0.001).
Conclusions
As compared with an insulin pump, a wearable, automated, bihormonal, bionic pancreas improved mean glycemic levels, with less frequent hypoglycemic episodes, among both adults and adolescents with type 1 diabetes mellitus. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov numbers, NCT01762059 and NCT01833988.)
