Remote Blood Glucose Monitoring in mHealth Scenarios: A Review <s> Sending Data from Diabetes Devices to the Cloud <s> Background: Communication of blood glucose (BG) results between patients and health care providers (HCPs) is of established benefit and remains a critical part of the diabetes management process. Currently, HCPs typically receive BG data from patients at the time of clinic visits or by telephone. The Accu-Chek® Acculink® modem (Roche Diagnostics Corp., Indianapolis, IN) provides an additional and attractive option that can potentially facilitate this communication. Methods: To assess the impact of modem transfer of BG, we studied 47 participants with diabetes enrolled in a diabetes education program. Subjects were randomized to weekly communication of BG data to their HCP by either telephone (n = 23) or modem (n = 24) for 4 weeks. Mean age (± SD) was 44 ± 15 years, 62% were female, 74% used insulin, 53% had type 1 diabetes, and mean baseline glycosylated hemoglobin (A1C) was 8.8% (range 5.2–13.2%). Results: There were no differences between groups in the amount of time the HCP spent analyzing BG data and ... <s> BIB001 </s> Remote Blood Glucose Monitoring in mHealth Scenarios: A Review <s> Sending Data from Diabetes Devices to the Cloud <s> ABSTRACTSelf-monitoring blood glucose (SMBG) systems have the potential to play an important role in the management of diabetes and in the reduction of risk of serious secondary clinical complications. This review describes the transition from simple urine sugar screening tests to sophisticated meter and reagent strip systems to monitor blood glucose. Significant developments in design and technology over the past four decades are described since the first meter was introduced in 1970. Factors that have influenced this evolution and the challenges to improve analytical performance are discussed. Current issues in the role of SMBG from the clinical, patient and manufacturer perspectives, notably adherence, costs and regulations, are also considered. <s> BIB002
The architectures for remote monitoring have evolved over the years, as described in Section 2. This evolution closely paralleled the improvements in the control logic of the devices generating the data to be monitored, as their manufacturers increasingly added computational and connectivity capabilities over time, leveraging the continuous achievements in ICT and microelectronics. The very first glucometers were analog devices able to acquire just one measurement at a time BIB002 . The switch to digital technology allowed for retaining several measurements in memory, while the parallel massive diffusion of the PC favored their interfacing with the devices and paved the way for remote monitoring applications. At first, manufacturing companies only allowed downloading data from their devices using serial ports and offered logbook applications to better analyze data on the PC display using charts and diagrams. These applications were used either by specialists that downloaded data from their patients' glucometers at regular visits, or by technology-savvy patients that annotated BGL readings with additional information for an improved control. Roche Diabetes Care GmbH (Mannheim, Germany) was the first company to sell a complete remote monitoring system with their Acculink. This was essentially a proprietary modem that allowed patients to regularly send data from their Accu-Chek glucometers to their doctor's office even without owning a PC. Roche also provided the application to be installed on a server at the clinic for receiving and storing the patient's data, therefore ensuring a better follow-up by doctors among scheduled visits BIB001 . Currently, almost any manufacturer supports downloading data from their glucometers. However, this still happens through different proprietary protocols that prevent the actual integration of data into a single application. Moreover, manufacturing companies are not interested in running remote monitoring services by themselves. Those problems were recognized by DiaSend (Askim, Sweden), which started its business in 2006 offering integration capabilities for all the major glucometers on the market in addition to many insulin pumps. The patient may use either his PC or his smartphone to download data from the devices and upload them onto a remote server managed by DiaSend so that they become easily accessible to the clinical staff. The company claims that almost 2000 clinics worldwide have already made arrangements with them and nearly 350,000 patients are regularly using it. Smartphones have been also increasingly exploited by manufacturers to simplify the acquisition of BGL measurements and import their values into the digital ecosystem. An interesting example is provided by iBGSTAR R produced by Sanofi (Paris, France), which is essentially a glucometer implemented as a hardware plugin for the smartphone. It is a very small piece of hardware that fits the iPhone or iPod docking connector and allows for measuring BGL using test strips. The hardware has a very small display that comes in handy just to preserve its usability as a standalone tool. However, the iBGSTAR R is best used in combination with the Diabetes Manager app, also from Sanofi. This app allows for importing BGL readings into the smartphone where they may be complemented with additional information manually provided by the patient concerning meals, insulin delivery, physical activity, drugs taken or notes. The application gives then a complete overview of the patient's state since it allows searching for specific events and produces charts and statistic diagrams. A different remote monitoring paradigm is being adopted by Dexcom Inc. (San Diego, CA, USA) with their G5 Mobile CGM System. This system encompasses two different smartphone applications, the Mobile/Share App and the Follow App. The former is installed on the patient smartphone and displays real-time glucose data and trends directly. Using this app, the patient may designate up to five people as followers, thereby including caregivers, clinical staff, family members or significant others. Once those people have installed the Follow App on their smartphones, they will all receive in real time the CGM readings and will be notified about critical situations occurring to the patient in order to possibly undertake actions. The need for a monitoring platform that overcomes the inherent limitations of proprietary protocols is probably best witnessed by the Nightscout Project  , which was initially born as CGM in the Cloud and eventually turned into The Nightscout Foundation  in 2014. This is an open source project started by some parents of children affected by T1D that are implementing a platform for real-time access to the patients' CGM data via websites, smartphones or smartwatches for their own serenity. Currently, Nightscout is able to interface and acquire data from sensors manufactured by Dexcom (G4, G4 with Share, G5), Medtronic (640g, 530g, Veo) and Abbott (FreeStyle Libre).