What Are the Next Steps in Continuous Glucose Monitoring?

Abstract

Continuous glucose monitoring (CGM) as a novel diagnostic technology is still in its infancy. Current CGM systems are still not optimal from a number of perspectives: duration of usability, measurement performance in all clinically relevant glucose ranges, handling, and making full usage of the information provided. A number of new CGM technologies are in development and will certainly play a major role in the market introduction of next generation glucose sensors (NGGS) in the next years. The aim of this commentary is to discuss emerging trends in CGM, with a focus on the usage of NGGS. Usage of CGM in the FutureCGM does not work as a stand alone system. The amount, that is, the amount of information about the glucose profile that this approach provides clearly requires the subsequent step of combining it in a smart way with insulin administration. There is a range of approaches as to how such a combination could look. In its most simple version, the CGM data are shown only on the display of a handheld device or another medical product device (smartphone, insulin pump, blood glucose meter). One step up from this sees the CGM system and the insulin pump more closely connected. In case the pump receives the CGM data directly it can interpret the CGM data and, for example, stops basal insulin infusions if glucose values decline below a certain threshold (low glucose suspend [LGS] systems). In this case, a predictive model analyzes the glucose profile and reacts when the prediction indicates that low glucose values can be expected within a determined amount of time (eg, 20 minutes) and stops insulin infusions before they take place. To close the loop for this smart system, CGM recordings are interpreted by an algorithm and changes to insulin infusion rates are (also an increase in case of evelated blood glucose values) initiated automatically by the system. In principle, this type of technical approach would mean that glycemia would remain within the euglycemic range under all daily life conditions-which would be the next best thing to the cure of diabetes. It remains to be seen if a fully automated artificial pancreas would also require a glucagon infusion to counteract insulin action. Nevertheless, it might very well be that not all patients can or will use an artificial pancreas (eg, for cost reasons). Therefore, the large group of patients treated with multiple daily injections (MDI) of insulin cannot simply be ignored. The number of clinical trials evaluating the benefit of CGM in this patient group is quite small; In most cases the patients included in clinical trials with CGM use an insulin pump. Even if the insulin therapy with MDI is not as flexible as with an insulin pump, such patients might also benefit from having more detailed information about their glucose profile. In the future, CGM usage will be embedded into the entire diabetes management process including routine diabetes education, analyzing and interpretation of data, as well as personalizing treatment goals in diabetes. Such a system may 5258...

Insulin Pump and CGM Usage in the United States and Germany

“…14,15 Among people who wear an insulin pump, the perceived benefits of CGM use appears to be widespread. Acceptance and ongoing use of CGM technology have been closely tied to user beliefs about accuracy.…”

Technology Use in Transition-Age Patients With Type 1 Diabetes

“…Unfortunately, insurers often make reimbursement decisions using historical data that may not represent the current state. 36 For example, large health insurers often cite lackluster adherence to consistent CGM use in early CGM trials 37,38 (eg, 30-55% subjects used CGM ≥6 days/week) to categorically deny coverage for those devices in transition-age youth, thus limiting our ability to assess its efficacy. In part, these decisions may explain the lower rates of technology utilization by a population that has otherwise wholeheartedly embraced technology integration in their day-to-day lives.…”

Electrochemical Glucose Biosensors for Diabetes Care

“…Instead, we choose to describe general system performance of four CGM systems which have either been introduced into the market place or are going to be introduced. Performance of current systems has been ranked as ranging from acceptable to good [467], clearly pointing to potential for improvement. A recent head-to-head performance study [265] investigated CGM-to-BG differences [(MARD) and sensor-to-sensor differences (PARD)] of 12 subjects with type 1 diabetes, where each subject wore two Abbott FreeStyle ® Navigator™, two MiniMed Guardian™ REAL-Time + Enlite™ sensor systems, and two DexCom™ Seven ® Plus 3rd-generation (Seven ® Plus) sensors.…”

“…Incorrect insulin dose recommendations may have fatal, surely negative consequences. In conclusion, sensor performance issues affecting system accuracy, precision, and reliability have been named as main obstacles for widespread complement or even replacement of spot glucose measurements [466,467]. Demands on accuracy, precision, and reliability required for approval of BGM systems are clearly described by the relevant ISO norm [17] (see Sect.…”

“…4.1. Lodwig et al [467] described concisely possible steps toward an artificial pancreas, as defined by the FDA [470], which appeal to patients on continuous subcutaneous insulin infusion (CSII) therapy. Patients who are treated with multiple daily injections (MDI) have identified clearly discernible benefits from CGM use.…”