TECHNICAL FIELD

The present disclosure relates generally to automated or semi-automated technical support of medical device systems. More particularly, the present disclosure is directed to systems, methods, apparatuses, and computer products for automated or semi-automated technical support of a continuous analyte monitoring system.

BACKGROUND

Diabetes mellitus is a disorder in which the pancreas cannot create sufficient insulin (Type I or insulin dependent) and/or in which insulin is not effective (Type 2 or non-insulin dependent). In the diabetic state, the victim suffers from high blood sugar, which causes an array of physiological derangements (kidney failure, skin ulcers, or bleeding into the vitreous of the eye) associated with the deterioration of small blood vessels. A hypoglycemic reaction (low blood sugar) may be induced by an inadvertent overdose of insulin, or after a normal dose of insulin or glucose-lowering agent accompanied by extraordinary exercise or insufficient food intake.

Conventionally, a diabetic person carries a self-monitoring blood glucose (SMBG) monitor, which typically requires uncomfortable finger pricking methods. Due to the lack of comfort and convenience, a diabetic will normally only measure his or her glucose level two to four times per day. Unfortunately, these time intervals are spread so far apart that the diabetic will likely be alerted to a hyperglycemic or hypoglycemic condition too late, sometimes incurring dangerous side effects as a result. In fact, it is not only unlikely that a diabetic will take a timely SMBG value, but will not know if his blood glucose value is going up (higher) or down (lower), due to limitations of conventional methods.

For example, diabetic patients sample their blood glucose levels several times throughout a day, such as in the morning, around lunch, and in the evening. The levels can be measured by taking a small blood sample of the patient and measuring the glucose levels with a test strip or glucose meter. This technique, however, has drawbacks because patients would prefer to not have to take a blood sample, and users do not know what their blood glucose levels are throughout the day between the samples.

Consequently, a variety of non-invasive, transdermal (e.g., transcutaneous) and/or implantable electrochemical sensors have been and are being developed for continuously detecting and/or quantifying glucose values, such as from sensor measurements having accuracy corresponding to direct blood glucose measurements. Continuous glucose monitors have been increasing in popularity as an easy way to monitor glucose levels and automatically alert the patient of glucose level events. For example, one potentially dangerous timeframe is at night because a patient's glucose levels can fall dangerously low during sleep. As a result, continuous glucose monitors have gained popularity by providing a sensor that continuously measures glucose levels of a patient and transmits the measured glucose levels wirelessly to a display. This allows the patient or patient's caregiver to monitor the patient's glucose levels throughout the day and even set alarms for when glucose levels reach a predefined level or experience a defined change.

Initially, continuous glucose monitors wirelessly transmitted data relating to glucose levels to a dedicated display. The dedicated display is a medical device designed to display glucose levels, trending patterns, and other information for a user. However, with the increasing popularity of smart phones and software applications (apps) executing on smart phones, some users prefer to avoid having to carry a dedicated display. Instead, some users prefer to monitor their glucose levels using a dedicated software app executing on their mobile computing device, such as a smart phone, tablet or wearable device like a smartwatch or smart glasses.

SUMMARY

One embodiment includes a system, wherein the system includes: a continuous analyte sensor device configured to sense one or more biological parameters of a patient user, generate real time medical data and bulk data, and selectively transmit the real time medical data and bulk data; a real time server configured to receive and store the real time medical data; a bulk data server configured to receive and store the bulk data; and a tech support server configured to identify a technical issue associated with the continuous analyte sensor device, at least in part by analysis of the stored real time medical data and the bulk data.

In one aspect, the analysis of the real time medical data and the bulk data includes a comparison of the real time medical data and the bulk data to determine discrepancies.

In another aspect, the system further includes a remote monitor device operated by a caregiver user affiliated with the patient user, the remote monitor device configured to receive the real time medical data and/or alerts associated with the real time medical data from the real time server, and to transmit an issue report indicative of the technical issue to the tech support server.

In another aspect, the system further includes one or more recording databases, wherein the tech support server is configured to modify the one or more recording databases in response to the identification of the technical issue.

In another aspect, the recording databases includes a regulatory incident records database.

In another aspect, the system further includes an engineering and design computing system configured to receive alerts or reports comprising the identified technical issue.

In another aspect, the reports or alerts comprise trends in emerging technical issues.

In one aspect, the tech support server is further configured to search for a resolution of the identified technical issue, resolve the identified technical issue and notify the patient user.

In one aspect, the system further includes a tech knowledge database, wherein searching for a resolution of the identified issue comprises querying the tech knowledge database.

In another aspect, the tech knowledge database further comprises a mapping of technical issues, known resolutions and scores associated with the known resolutions.

In one aspect, the tech knowledge database is routinely purged of low score resolutions.

In one aspect, the system further includes a transceiver configured to selectively receive the real time medical data and bulk data, transmit the data to the real time server, the bulk data server or both; and an application running on the transceiver configured to gather data related to the technical issue, generate and transmit an error ticket containing the technical issue and the gathered data to the tech support server.

In another aspect, the system is further configured to gather data based on patient inputs related to the technical issue.

In one aspect, the system further includes a tech support personnel computing system, configured to receive the identified technical issue and a report of the tech support server related to the identified technical issue.

In another aspect, the technical issue comprises a sensor failure and the tech support server is configured to order a replacement sensor and provide tracking information to the patient user.

Another embodiment includes a method where the method includes: sensing one or more biological parameters of a patient user; generating real time medical data and bulk data from at least the sensed one or more biological parameters; transmitting the real time medical data to a real time server; storing the real time medical data in the real time server; transmitting the bulk data to a bulk data server; storing the bulk data in the bulk data server; and identifying a technical issue at least in part by analysis of the real time medical data and the bulk data.

In one aspect of the method, the analysis of the real time medical data and the bulk data includes a comparison of the real time medical data and the bulk data to determine discrepancies.

In one aspect, the method further includes transmitting, from the real time server, the real time medical data to a remote monitor device operated by a caregiver user affiliated with the patient user, the remote monitor device configured to receive the real time medical data and/or alerts associated with the real time medical data; and receiving, at the tech support server, an issue report indicative of the technical issue to a tech support server.

In another aspect, the method further includes modifying one or more recording databases in response to the identified technical issue.

In another aspect, the one or more recording databases comprise a regulatory incident records database.

In one aspect, the method further includes transmitting alerts or reports to an engineering and design computing system.

In another aspect, the reports or alerts comprise trends in emerging technical issues.

In one aspect, the method further includes searching for a resolution of the identified technical issue, resolving the identified technical issue and notifying the patient user.

In one aspect, searching for a resolution includes querying a tech knowledge database.

In another aspect, the tech knowledge database further comprises a mapping of technical issues, known resolutions and scores associated with the known resolutions.

In one aspect, the method further includes routinely purging the tech knowledge database of low score resolutions.

In another aspect, the method further includes: gathering data related to the technical issue; and generating and transmitting an error ticket containing the technical issue and the gathered data to a tech support server.

In one aspect, the method further includes gathering data based on patient inputs related to the technical issue.

In another aspect, the method further includes sending the identified technical issue and a report of the tech support server to a tech support personnel computing system.

In one aspect, the method further includes ordering a replacement sensor and providing tracking information to the patient user in response to the identified technical issue.

