Diabetes is rapidly becoming a major health epidemic in most regions of the world. All patients with type 1 diabetes and a significant number with type 2 diabetes require the use of insulin for controlling blood glucose. The World Health Organization (WHO) estimates that globally, high blood glucose is the third highest risk factor for premature mortality, after high blood pressure and tobacco use. Type 1, diabetes is less common than type 2 diabetes and is increasing by approximately 3% each year globally. According to the International diabetes federation (IDF) around 464.1 million people are suffering from diabetes as of 2019 worldwide and estimated to reach 700 million by 2045.
There are many ways to induce insulin such as insulin pumps, injections, and pens. Insulin pumps also known as Continuous Subcutaneous Insulin Infusion therapy (CSII), mimic the work of human pancreas by delivering small doses of short and rapid-acting insulin continuously, pumps containing insulin in the reservoir is delivered through infusion set attached to flexible tubing (catheter) and further passed into patient’s bloodstream at a more precise and flexible rate with improved glucose control. The device releases insulin with a steady flow rate throughout the day and night, called basal insulin, and an extra dose at mealtime called a bolus. Insulin injections and insulin pens are the most common treatment for diabetes in which patients can self-administer insulin at home. However, these are the conventional methods having disadvantages over the insulin pumps such as injections requires up to seven needle pricks per day, delivers insulin less accurately than insulin pumps that result in greater variability in blood glucose level or less accurate glycemic control and requires more planning about the restrictions regarding meals and exercise.
Insulin pumps are available in two forms such as tethered pumps and patch pumps, tethered insulin pumps have flexible tubing between the pump and the cannula, these pumps are worn on abdomen or buttocks or occasionally on the thighs and can be carried on a belt or in a pocket. Patch pumps that are disposable insulin pumps controlled wirelessly by a separate device that will provide information about insulin delivery for meals from the patch. Patch pumps are worn directly on the body that will have a reservoir, pumping mechanism and infusion set inside the small case and the parts are associated without tubing. The patch pumps are regularly replaced every three days.
The cutting edge innovation in insulin pump is direct interaction of the device with Continuous Glucose Monitoring System (CGMs) and glucose can be interpreted and determined by an algorithm, known as closed-loop insulin pump also called as the artificial pancreas. This system can be used in both automatic and manual modes. In manual mode the user can set the pump to suspend activity at or before low glucose values and in automatic mode, the system uses the algorithm to adjust basal insulin delivery in response to fluctuations in interstitial glucose levels. Some of the advantages of hybrid closed-loop pump systems are more consistent glycemic management compared to sensor-augmented insulin pumps.
In March 2019, EoFlow a South Korean company has received a breakthrough designation for EoPatch insulin pumps an automated Insulin Delivery (AID) system called EoPancreas. This is the fourth diabetes hybrid closed-loop system that the FDA has granted the new breakthrough device designation. In addition, in November 2018, Diabeloop S.A. received CE market approval for the DBLG1 hybrid closed loop an automated insulin delivery system. DBLG1 will be the first launch in France in early 2019, followed by other European countries, for adults with type 1 diabetes, this is the second AID system to be approved in Europe, in addition to the Medtronic MiniMed 670G.
According to IQ4I analysis, insulin pumps market is expected to grow at a high single-digit CAGR from 2019 to 2026. Total Addressable Market (TAM) for insulin pump is expected to be $47,662.4 million in 2019, the insulin pump has reached 5.1% of the insulin-dependent population and still, there is scope to reach 94.9% of the insulin-dependent population.
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