In 2018, nearly 500 million people were reported to have diabetes all over the world. It has been expected that this number is going to increase to approximately 630 million by the end of 2045. Diabetic patients rely on treatment options such as insulin pump therapy and multiple daily injections with continuous monitoring of glucose. These treatment options are effective yet considered troublesome as they require a regular drawing of blood to check glucose levels for the appropriate injection of insulin therapy. The intake of multiple injections of insulin may result in the circulation of high levels of insulin in the bloodstream. This may cause a drop in blood sugar at dangerously low levels. These unexpected variations in the levels of blood glucose lead to various complications and therefore, require frequent monitoring and management to avoid dangerous outcomes.
Artificial Pancreas: An Effective Solution to Present Diabetic Needs
For improving the quality of life in people suffering from this disease, researchers have managed to develop a hybrid closed-loop system device, also known as “artificial pancreas.” The working of this device is closely related to the functioning of a healthy pancreas. The algorithms used in the system of artificial pancreas uses information from continuous monitoring of glucose, past delivery of insulin, and conceivably, other accessible signs, for the recognition of fluctuation patterns in the blood sugar and anticipate the direction of the blood sugar. The artificial pancreas, therefore, monitors and adjusts blood sugar levels with the help of continuous glucose monitor and transmits data to the insulin pump that administer insulin into the body as needed. This innovation will likewise empower the control of exceptional and surprising varieties in blood glucose levels, particularly those that may happen without alarming the patient, for example, during games exercises or rest.
Components of an Artificial Pancreas Device System
Continuous Glucose Monitor: It provides information about the levels of blood glucose in the patient’s body. A sensor is placed subcutaneously under the skin of a patient that measures the glucose in the interstitial fluid. The information is sent by a transmitter to a receiver. Continuous glucose monitor continuously shows the estimations of blood glucose levels, their direction as well as the rate of change of these estimations.
Control Algorithm: It is software implanted in an outside processor that gets data from the continuous glucose monitor and performs mathematical computations. In view of these computations, the controller sends dosing guidelines to the insulin pump. The algorithm can be run on multiple devices such as an insulin pump, cell phone, or a computer.
Insulin Pump: The insulin pump adjusts the delivery of the insulin to the skin tissues on the basis of the instructions sent by the controller.
The Patient: The patient is a significant part of the Artificial Pancreas Device System. The blood sugar concentration in the patient’s body constantly changes that is influenced by the activity levels, diet, and how their body processes insulin as well as other substrates.
Minimed 670G approved by the Food and Drug Administration (FDA) in September 2016 is the world’s first approved artificial pancreas developed by Medtronic. Initially, it was approved for type 1 diabetes (T1D) patients aged 14 years or older; the device later received expanded approval in 2018 for use in children between 7 and 13 years of age. This device additionally got European approval in 2018, making it accessible to T1D patients over 7 years old. In February 2018, the new indication to insert the sensor into the upper arm of the patient was added in the approval.
Other outstanding systems incorporate DBLG1 framework developed by Diabeloop’s. This device got a certification mark in 2018 and will probably hit the French market by the end of 2019. This device highlights cell phone availability, enabling patients to see readings and change dosage with the help of their smartphones.
A South-Korean Company developed “EoPancreas” an automated insulin delivery system received breakthrough device designation by FDA in March 2019. This device uses the patch pump “EoPatch” integrated with a continuous glucose monitor sensor.
A San Francisco-based start-up Pancreum Inc. is also planning to develop a modular design to create a flexible and useful artificial pancreas system for patients with T1D.
Furthermore, numerous clinical trials, including those supported by Medtech organizations, government sponsors, as well as third-party organizations, have validated the safety and efficacy of artificial pancreas device systems. In many studies, these devices have proven to provide improved glucose control and decrease hypoglycemia risks in diabetic patients.
Artificial Pancreas Holds Great Future
The enthusiasm for artificial pancreas device systems has even driven the FDA to create explicit rules and benchmarks for these items; the association has additionally been taking part in counseling interactions with different diabetes groups and specialists to guarantee that administrative boundaries do not unnecessarily hamper the advancement of these frameworks. Moreover, FDA proposes that more ought to be done to survey cost-viability to help adoption of artificial pancreas frameworks in clinical practice.
Researchers suggest that future research should be done to investigate the use of artificial pancreas in different groups of diabetics and state the impact of this device on personal satisfaction and on reducing the burden on the patients should also be investigated.
There are immense potential advantages of these frameworks that can radically improve personal satisfaction. With the emergence of positive clinical data and the increase in affordability of these devices, the penetration and uptake of these devices will rise significantly.
Artificial pancreas device systems will make a generous move in the insulin delivery market that will support companies that are now occupied with creating this device. In addition, the expanding popularity of these devices, and the approaching accessibility of comparable gadgets will represent a critical danger to makers of other care gadgets, for example, patch pumps.
As of 2019, “breakthrough device designations” have been granted by FDA to different technologies including EoFlow, Bigfoot Biomedical, and closed-loop products of Medtronic. These designations are granted to these innovative devices in order to quicken the process of the regulatory review process. Artificial pancreases will hence be well-situated for a huge development in the years to come.