Guide for Pharmaceutical Manufacturing Quality Assurance New Drug Research : Artificial pancreas system

New medical device artificial pancreas:

Diabetes is considered a life long disease, though it poses serious health challenges to human being, diabetes can be managed efficiently with balanced and controlled diet, and exercise along with antidiabetic medicines.

Diabetic patient is required to take anti diabetic drugs or insulin shots through out and there happens that the patient gets a high blood glucose level and a low blood glucose level before and after anti diabetic drug or insulin dose. Low blood sugar (hypoglycemia) level may become serious and life threatening to patient, and high blood sugar level makes patient vulnerable to high blood pressure and heart diseases.

Blood glucose is controlled by a hormone Insulin which is produced by pancreas, a person get diabetes whenever there is any defect in pancreas(autoimmune disease) or whenever insufficient quantity of insulin is produced in event of high demand or whenever body muscles and body tissues develop resistance towards indigenous insulin.

Therefore a system which will exactly function as a pancreas in our body and take care of all such events smoothly and maintain blood glucose level like a normal healthy pancreas, will be soon available for diabetic patients and it is studied extensively by many pharma companies around the world, US FDA also has published guidelines for pharma companies developing such artificial pancreas system .

Artificial pancreas system will sense situation of low blood glucose in the patients body and minimize the input dose of insulin and when it sense a rise in blood glucose it will calculate a dose of insulin exactly sufficient to maintain blood glucose level to optimum level. The system will work autonomously in the similar manner as that of pancreas.

Regulation of blood glucose by pancreas:

In our body, the event of hypoglycemia the low blood glucose level is sensed by endocrine system and a hormone glucagon is released in to blood, which is also produced by pancreas, function of glucagon is exactly reverse of insulin, glucagon stimulate body and liver to convert glycogen in to free glucose which can be then used by body.

The event of high blood glucose level is sensed as a feed back mechanism by our body and insulin is released by pancreas which mobilize the glucose from blood in to body tissues.

An artificial pancreas system will make use of similar sensory path as above by using feedback mechanism by monitoring level of glucagon, blood glucose and insulin, all together and will be set in to an algorithm which will help the artificial pancreas to calculate future dose as well as the required dose of insulin to maintain blood sugar level to an optimum level even when a patient is doing his own work or when sleeping.

An artificial pancreas will include following components as shown in picture.