Automated Blood Glucose Monitoring

Frost & Sullivan analysts have seen several new approaches emerge to address diabetics’ daily challenges. The common theme is an attempt at automation. Read more about the latest developments.

Diabetes is a chronic condition affecting more than 415 million people worldwide. Poor control over the disease can damage internal organs and blood vessels in the long term, resulting in further complications; with co-morbidities, diabetes can also be fatal. It is crucial for diabetics to maintain good control over the condition for life.

A diabetic, whether type 1 or type 2, must take daily blood glucose readings to exert control over the disease. Type 1s must take several glucose readings in a day because of the nature of the disease, while Type 2s must take readings at least once a day, based on their doctor’s recommendation. Compliance with this arduous procedure is low, and is complicated by the nature of the tools. Diabetics must prick a finger with a lancet every single time they need a measurement, squeeze the finger to draw out a drop of blood, and then deposit that drop on a strip that can be inserted in a glucometer for measurement. Not only is the procedure invasive and, therefore, somewhat painful, it also requires diabetics to carry all components—lancets, strips and glucometer—wherever they go. The burden of doing this procedure more than once a day every day of their lives is bound to reduce the rate of compliance over an extended period of time. Some diabetics also feel embarrassed performing this procedure in public.

Frost & Sullivan tracks all developments in the diabetes market, especially around glucose monitoring, which has seen significant activity in the last few years. Analysts have seen several new approaches emerge to address diabetics’ daily challenges—from the likes of Google and Novartis working together on a contact lens for detecting glucose in tears to several start-ups attempting to detect glucose noninvasively. The common theme is an attempt at automation—both to improve diabetics’ quality of life and get more data points on glucose levels to help them better manage their condition. Among the latest developments, this discussion will focus on those in the orbit around traditional blood glucose meters and continuous glucose monitors.

Traditional Blood Glucose Meters

Traditional glucometers have remained more or less unchanged for decades from the user’s point of view. This is changing with attempts to bring in an “all-in-one” design. Consider Intuity Medical’s POGO system. It simplifies the process of glucose measurement by requiring only a single device that has a built-in lancet and a cartridge that can perform 10 tests before replacement. The process is simplified to press (for lancet), test (with cartridge) and repeat (reload after 10 times). A similar approach is that of Sentec Scientific’s NoStrip, which can perform 100 tests in a single cassette.   Slightly different variants are the SugarCube, which still needs an external test strip but integrates the lancet and the reader; Dario, which can connect to a smartphone that works as the display device, and Akibah, which is a smartphone case called Glucase that performs the test and displays results on the smartphone, and has compartments to store test strips and lancets.

Continuous Glucose Monitors

The other approach is of continuous glucose monitors (CGMs), which obviates the need for glucometers, lancing and carrying around test strips. The costs of these devices are significantly higher so adoption is low, but they provide a stream of data on glucose levels (collected every 5 to 15 minutes) for a much better understanding of a patient’s glucose level fluctuations. Treatment can, therefore, be personalized and can lead to overall better management of the condition.

There are two broad device categories: semi-invasive and implant-based.

Semi-invasive CGMs rely on a sensor placed on the arm or belly (or other areas as deemed fit by the doctor), with microneedles piercing the skin. The objective is to sense the glucose levels in the interstitial fluid that runs between body cells in the tissues below the skin. The drawback is that the glucose levels are not real-time: there is a lag of approximately 15 minutes between the glucose levels in the blood and in the interstitial fluid, but results are still considered acceptable (though not ideal). The components of such devices usually are a disposable sensor and a reader/display. The sensor communicates glucose readings continuously to the reader via Bluetooth or other technology. The recent trend, however, is to replace the reader with the user’s smartphone, which can also allow for sharing of the readings and associated trend reports directly with doctors.

The leading companies in this space are Dexcom and Abbott, with Medtronic following closely. Senseonics has a newly approved device with a 90-day sensor (whereas other sensors last for 5 to 7 days). Abbott’s solution, the FreeStyle Libre, is a little different in being not a true CGM but what is termed as flash glucose monitoring. The difference is in the way the readings are collected: the 14-day sensor does not communicate the readings directly to the reader, but relies on the diabetic to wave the reader over the sensor to collect all readings since the last instance. In this sense, while the glucose readings are collected continuously by the sensor, they are available for trend analysis or alerts on low or high blood glucose levels only after the reader collects the data. However, because these devices are much cheaper (Abbott touts these as mass-market devices), and with regulatory approvals in place in the United States and Europe, Abbott is aiming for 1 million users for the FreeStyle Libre, which is ambitious given the current penetration of CGM devices (hovering in the thousands). For perspective, Dexcom’s CGM starter kit starts at about $1,200, while Abbott’s starter kit (in Europe) starts at about $200. Both require the sensors to be replaced, at a cost of about $60 each time.

Implant-based CGMs are a little trickier: they have an implant in the body—still below the surface of the skin—but these sensors are touted to last for a year or two. In essence, they require a minor procedure for implantation versus the semi-invasive ones that can be placed by a general physician, a diabetologist or, in some cases, the patient at home. However, since none of these are yet commercially available, it remains to be seen whether they will succeed in the long run. Cost remains the primary hurdle for adoption of these technologies, and while annual cost calculations may be impressive for payers when opting for reimbursement, individual, out-of-pocket payers tend to rely more on lower upfront costs, given Abbott’s experience with the Libre.

Glucose Monitoring Data

Regardless of the source of the glucose data, it can be processed in various ways to better understand a diabetic’s condition for long-term management. For example, those dependent on insulin can benefit from studying glucose levels and insulin dosing trends to calculate optimal dosages. Companies including DreaMed Diabetes and Mellitus Health have such solutions. These approaches extend the automation concept beyond simply collecting glucose data to actually leveraging the data automatically to help diabetics.

The Road Ahead

The future of this industry lies in:

  • Improving convenience for diabetics in collecting glucose levels;
  • Increasing adoption of CGM technologies, especially for type 1 and insulin-dependent type 2 diabetics; and
  • Leveraging data analytics for crunching glucose data to help diabetics better manage condition with respect to food intake, exercise and medication.

Technological advancements will improve the quality of life for diabetics—with automation!

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