The United States Food and Drug Administration (FDA) has approved the First Artificial Pancreas ever created for automated insulin delivery to patients with Type 1 Diabetes. This past Wednesday, September 28th, Medtronic’s MiniMed 670G hybrid closed-loop insulin delivery system was accepted by the federal agency as the first ever device that will both monitor the blood’s glucose levels and administer insulin doses for patients over the age of 13.
Type 1 Diabetes is an autoimmune disease which induces the body’s defenses to attack insulin-producing cells, effectively shutting down the production of insulin on the patient’s body. Insulin is a hormone produced in the Pancreas that regulates the blood’s sugar levels. Without it, the body has no effective way to metabolize carbohydrates, proteins, or fat, which cannot be properly synthesized by the body resulting in abnormally high blood sugar levels.
Patients with this disease have to live constantly scrutinizing their blood’s glucose (sugar) levels to ensure that they are inside of a healthy range. This involves the use of a Glucose Meter to get blood samples, and manual injections with an Insulin Pen to administer enough Insulin to counterbalance sugar levels. Unfortunately, this method is not only uncomfortable for the patient – who needs to be constantly on the watch of his diet and sugar levels- but it is vulnerable to human error, either by the patient miscalculating his glucose intake, or by him taking the wrong amount of insulin.
This new device will eliminate human error from the equation by supplying just the right amount of insulin that the body requires to process its daily glucose intake. Although the MiniMed 670G still requires the patient to monitor and input the amount of carbohydrates he is eating, it also frees him from having to administer insulin dosages to himself, guarantying that the patient’s blood glucose levels will remain on normal levels even when he sleeps.
In order to earn the FDA’s approval, Medtronic ran tests on 124 patients with Type 1 Diabetes between 14 to 75 who wore the device for 3 months, reducing both their levels of high and low pressure. The device tested the patients’ blood glucose levels every 5 minutes to test its own safety in relation to causing Hypoglycemia and Diabetic Ketoacidosis (DKA), but also to monitor the changes in Glycated Hemoglobin (A1C), the impact the person’s weight and dosage, the time spent in different sensor glucose ranges.
The data results showed the levels of Glycated hemoglobin – a type of hemoglobin which is the primary marker used to identify average glucose level over a 3 month period – were reduced from 7.4% to 6.9%, while the Sensor glucose value (glucose readings taken from the fluid that surrounds cells of tissue below the skin) changed from 66.7% to 72.2%
The device allows for a level of control on sugar levels that was previously unheard of. Before the invention of this system patients usually checked their sugar levels 6 or 7 times a day at most. Now, thanks to the automatic monitoring system, patients can go on with their daily life without having to take their own blood samples and enjoy having glucose levels that are close to normal as possible. Besides having to input an approximate of the carbohydrate count of his meals, the patients can go on with their day without having to worry about monitoring and adjusting the glucose levels.
Patients can use the system in either Manual or Auto mode. Manual mode can be programmed by an MD or the patient itself to deliver pre-scheduled doses of insulin at a constant rate. Any glucose reading out of the ordinary range will cause the next dosage to be suspended until the levels are normal again. In Auto Mode the system decides for itself on how often an how much insulin it will supply to the patient based on the Continuous Glucose Monitoring values. Still, Auto Mode doesn’t take into account the user’s meals so he must still manually apply himself insulin injections with each meal.
The entire system is composed of the MiniMed 670g insulin pump, the Guardian Link transmitter, a One-press serter, a Guardian Sensor (3), and a Contour Next Link 2.4 glucose meter. The Guardian Sensor (3) provides an additional level of safety by indicating when a fingerstick may be required. However, the system does not take manual injections into account so patients taking insulin injections need to make sure to turn off Auto Mode to avoid the risk of taking too much insulin and developing Hypoglycemia.
Other than requiring the patient to input his carbohydrate intake the MiniMed 670g works automatically, keeping the glucose levels on a normal range by constantly adjusting to any changes. When the system measures abnormal sugar levels on the blood it will supply the body with an insulin dosage through a small catheter on the insulin pump, and it will shut down when the body glucose levels are too low.
However, the device is still not perfected and Medtronic plans to continue its development. The system can only measure the patient’s blood glucose level, but the patient is still required to input the amount of carbohydrates which he is consuming. All measurements taken by the system are displayed on the device’s screen, including glucose trend information, pre-programmed alerts, and alarms set by glucose levels out of the ordinary range
The MiniMed 670G is planned to be available next year. In the meanwhile, it’s still undergoing trials to guarantee its effectiveness amongst patients aged 7-13. Currently it is only approved for people aged 14 and older. Pregnant women,patients with impaired kidney function, and people unable of unwilling to perform a minimum of four blood glucose test each day are advised not to use it. People with hearing impairment or vision problems could also have problems to read the glucose data or recognize the system’s alarms, or alerts.
While the cure for Diabetes maybe years, or even decades ahead, the MiniMed 670g will improve the quality of life of patients allowing them to live a normal life, without incurring the hassle of constantly checking and worrying about their sugar levels, but more importantly, it will reduce the chances of developing dangerous complications like Hypoglycemia, Diabetic Ketoacidosis Hyperosmolar Hyperclycemic State, all of which can be caused by an inadequate insulin treatment.