WILL TECHNOLOGICAL INNOVATION IN DIABETES MONITORS MARK A NEW ERA?

Published On: November 2017

Diabetes is one of the major health conditions of our time as it leads to rising morbidity and mortality, and also diminishes the quality of life of a large number of affected individuals and their families to a great extent. Management of diabetes is the most successful mean for its control. Glucose monitoring is used to optimize treatment strategies and provide an insight into the effect of diet, medications, and exercise on the patient. According to a study published in Diagnostics journal, non-invasive glucose monitoring (NGM) is widely accepted blood glucose measurement method as it alleviates the pain of pricking the skin, and NGM based continuous glucose monitoring systems (CGMS) are very beneficial at lowering the HbA1c level. Due to increasing acceptance of CGM systems multitude of products have been introduced by leading players such as Medtronic Diabetes Guardian Real-Time, DexCom G4 Platinum, MedtroniMiniMed Paradigm Real-Time Revel, and others. With further technological development, Abbott brought a flash glucose monitoring (FGM) system to the market i.e., Freestyle Libre. In contrast to the available CGM systems, the Freestyle Libre does not require calibration. The increasing utilization of mobile apps also motivates researcher to come up with innovative ideas to improve diabetes control status. Several new smartphone apps have been introduced to improve the patient-physician connectivity, such as Smart “Sox”, Glucose Buddy, and ShugaTrak.

How are CGM tech devices offering new opportunities for the growth of the market?

Although point-in-time (fingerstick) blood glucose monitoring method is the gold standard medium for glucose sampling, however, the resulting measurements can be particularly problematic. The readings attained by traditional blood glucose meter fail to provide key information regarding the blood glucose level and sufficient warning of severe hyperglycemia, thus, limiting the patient’s ability to maintain optimized glucose level.

Continous Glucose Monitoring (CGM) usage is increasing as an adjunct to Self-Monitoring Blood Glucose (SMBG). According to a study published in Diagnostics journal, non-invasive glucose monitoring (NGM) is widely accepted blood glucose measurement method as it alleviates the pain of pricking the skin and, NGM based continuous glucose monitoring systems (CGMS) are beneficial at lowering the HbA1c level. CGM system displays updated glucose level using various biological fluids present in the body. Although blood remains the most commonly used sample, other biological fluids such as ocular fluid, sweat, breath, interstitial fluid, saliva or urine can also be used as an alternative sample for non-invasive continuous monitoring. The system also produces trend graphs of glucose level and alarms to warn the user for high or low glucose levels.

The most notable benefit of CGM is the time-series glucose data. Traditional glucose monitoring method provides only snap-shots of glucose concentration and depends upon the number of finger-sticks a patient performs per day. In contrast, CGM can provide up to 288 glucose values per day. 

Existing and new marketers are continuously coming up with innovative products to meet the proposed FDA guidelines. In recent years, various new glucose monitoring devices have been approved by FDA and European regulatory bodies such as DexCom G4 Platinum, Medtronic Diabetes Guardian Real-Time, Abbott Freestyle Libre, GMate Smart Blood Glucose Monitoring System by Philosys, Artificial pancreas system, and many others. For bootstrapping earnings, and acquiring unique capabilities or resources mergers and acquisitions are observed such as Panasonic Healthcare Holdings, Co., Ltd. acquired diabetes care business of Bayer AG for around USD 1.17 billion on January 05, 2016. LifeScan Inc., a world leader in blood glucose monitoring, teamed up with WellDoc Corporation to advance Mobile Care Solutions for Type 2 Diabetes Patients on September 13, 2016.

How is Abbott gaining ground over other glucose monitoring systems?

The Abbott’s FreeStyle Libre system launched with an entirely new concept in glucose monitoring by providing more detailed information in comparison to blood glucose testing, and being more affordable than CGM systems.

Abbott Freestyle Libre System has been approved by the FDA and it is the first CGM for use without fingersticks. There are numerous other players operating in the diabetes monitors market globally. The Asia Pacific is one of the fastest growing markets, companies are grabbing the opportunity and are keen on expanding their units in this region. Some of the key players that hold maximum share are LifeScan, Inc., F. Hoffmann-La Roche Ltd, Panasonic, Sanofi, Dexcom, Inc., Medtronic, and Abbott Laboratories.  

What are the factors hampering the growth of the market?

With the increasing technological advancements in glucose measurement devices, huge investment in device production process has also been observed. In some developed countries like the United States, various reimbursement policies have been introduced to prevent the onset of diabetes and to reduce treatment cost. The Centers for Medicare & Medicaid Services (CMS) is going to expand Diabetes Prevention Program in 2018 to reduce net Medicare spending and to improve the patient care quality without limiting coverage or benefits in the United States. But the scenario is different in developing and some developed countries as no reimbursement are provided by the health insurance companies. This factor may greatly hamper the growth of the market. Although, newly advanced CGM system offers various benefits over other conventional systems, but the high cost of CGM system may strongly affect the growth of the market, especially, in developing countries. Considering a research study published in Journal of Diabetes Science and Technology in 2015, only a few patients in Germany i.e., <2000 use CGM due to the high costs.