The diabetes medical device market encompasses many different categories and sub-categories, and the disease continues to be a major problem. Even though uncertainties continue to plague the healthcare system in the U.S., the market should continue to trend upward in the coming years.
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Blood glucose meters are electronic devices that analyze a small drop of blood that is drawn using a lancet and lancing device. The blood is placed on a small disposable test strip that is inserted into the blood glucose meter, which reads the level of glucose in the blood. The blood glucose meter is battery-powered and fits in the palm of the hand. When the blood is placed on the strip, it flows in through capillary action. The electrochemical reaction between the test strip and the blood determines the blood glucose concentration reported as milligrams per deciliter (mg/dL) or millimoles per liter (mmol/L).
Blood glucose test strips are thin strips with enzymes that react to blood droplets. These create either a photometric or electrochemical response which is read by a glucose meter. Strips vary by size, chemical makeup, fluid channels, etc. and are typically sold in containers of 50 or 100. A single strip is used for each test, and some brands have preloaded strip storage within their meters. Electrochemical strips are the most popular type, largely due to the extremely small volumes of blood required to measure glucose. These strips function by working with the blood glucose meter to produce an electrical current, which is proportional to the blood glucose concentration. Several different enzymes may be used for transferring electrons from the glucose in the blood to the electrode. Typically, the current can be measured in between 5 to 15 seconds.
Continuous glucose monitoring (CGM) allows for a more accurate reading of how blood glucose levels fluctuate throughout the day by measuring interstitial glucose levels on a continuous basis and estimating blood glucose levels based on these readings.
The CGM system is typically made up of three components: a glucose sensor, transmitter and receiver. The sensor is inserted under the skin into the interstitial fluid and held with an adhesive. Sensors are typically sold in groups of four and are labeled for three to seven days of use, depending on the manufacturer. A transmitter takes the glucose reading from the sensor and wirelessly sends it to a small, hand-held receiver. If glucose levels are too low or high, the receiver warns the patient. Some manufacturers have even built-in a threshold audible alarm as a fixed safety feature when the patient approaches levels below 55 mg/dL, at which point the patient is still interactive but severely hypoglycemic.
The FGM system is made up of two components: a sensor and an electronic reader device that takes readings of glucose levels from the sensor. Sensors are worn on the back of the upper arm of patients for up to 14 days and inserted in a similar fashion as CGM sensors, with an adhesive to hold it in place. The reader component is manually placed over the sensor and after about a second, the reader displays a measurement of the patients glucose level, a historical trend of previous scans and the direction in which the glucose level is moving. A recent product update allows patients to use near-field communication (NFC) technology to substitute their smartphones as the reader component, eliminating the need to purchase the dedicated reader device. The FGM system is also factory calibrated which removes the need for routine fingersticks; something that is not available in current CGM systems. These features are popular with patients who cite the pain, inconvenience and indiscretion of fingersticking as the primary reasons for not managing their diabetes as efficiently and proactively as they should.
Insulin is a hormone that causes glucose uptake from the blood through the cells of the liver, muscle and fat tissue to be stored as glycogen in the liver and muscle. Type 1 diabetics immune systems destroy pancreatic beta cells: the only cells that can make insulin. The body therefore fails to produce insulin and cannot naturally convert food into energy. Type 2 diabetics have a resistance to insulin, and cells are not able to use the insulin present in the body. The need for insulin increases to the point that the pancreas can no longer produce it. Insulin is therefore a mode of treating both type 1 and type 2 diabetes.
Insulin is a protein and when administered orally, it degrades in the stomach and the intestines. When administered subcutaneously, it is better absorbed and has more of an effect on blood sugar levels. Many alternative technologies have entered the insulin delivery device market, such as insulin pumps and insulin pens, resulting in a fast decline in insulin syringe use across Europe.
Insulin syringes are moving from being hypodermic to those with finer points. Syringes are used with 10 mL insulin vials and come in 0.3 mL, 0.5 mL and 1 mL calibrations. In addition, thinner and shorter syringes are becoming more popular in the market, as they cause less discomfort when giving an injection. Needle thickness is indicated by gauge number; the higher the gauge number, the thinner the needle.
A lancet is a small needle with a plastic or rubber coating that fits into the top of a lancing device. Lancing devices are pen-like instruments which are used in conjunction with a lancet to draw blood to be applied to a glucose strip. Many lancets come as a component of blood glucose monitoring kits, and can be adjusted for injection depth. Reusable lancets are not as effective as they are more dull and painful and increase the risk of infection.
Insulin pens are shaped like a writing pen, but have a reservoir for insulin and are used as a delivery method for insulin. To administer insulin, patients must remove the pen cap, clean the injection site with an alcohol swab, attach a pen needle, prime the pen, dial the appropriate dosage amount and finally inject the insulin. There is a dose dial on the side of the pen so the patient can choose the required dose.
Insulin pens are either prefilled or reusable with a disposable cartridge component, and generally carry 300 units of insulin. Most brands of insulin are available in pen format. This delivery method offers several advantages over the traditional vial and syringe delivery method. Pens offer ease-of-handling, improved accuracy, more discreet use and less injection pain.
The traditional blood glucose monitoring market, also referred to as the self-monitoring of blood glucose (SMBG) market, includes devices used for testing the concentration of glucose in blood. Meters analyze a small drop of blood that is drawn using a lancet and lancing device. The blood is placed on a small disposable test strip that is inserted into the blood glucose meter, which reads the level of glucose in the blood. The blood glucose meter is battery-powered and fits in the palm of the hand. When the blood is placed on the strip, it flows in through capillary action. The electrochemical reaction between the test strip and the blood determines the blood glucose concentration reported as milligrams per deciliter (mg/dL) or millimoles per liter (mmol/L).