The customer is a well-known, cutting-edge medical device manufacturer that produces and sells finished medical devices as that word is defined in the Food and Drug Administration’s Current Good Manufacturing Practices rule.

People with Type 1 diabetes who need to take insulin to control their blood sugar must have quick access to that information. This information is essential for helping them modify their lifestyles, which is a crucial part of diabetes therapy. They must wait three months until their next appointment with a doctor to take measurements and determine whether they are fulfilling glycemic goals.

A HIPAA-compliant data-driven diabetes management system that gathers unprocessed data from the continuous glucose monitor and insulin pump and uses an ETL process to turn it into reports and insightful data that can help healthcare professionals make clinical decisions.

Continuous Glucose Monitor And Algorithms To Manage Insulin Delivery

By using information from its automated insulin delivery system, a top-tier creative medical device business hoped to find a solution to this issue. The device automatically gathers crucial data every few minutes around-the-clock by combining an on-body insulin pump, controller software, continuous glucose monitor (CGM), and algorithms to manage insulin delivery based on CGM sensor measurements.

Client Recognized The Potential Of Using User Data To Fill Information Gaps And Enhance Diabetic Care

To provide healthcare practitioners with proven, actionable insights and near-real-time reporting, they intended to create a data-driven diabetes management system. Accordingly, they requested assistance from AiRo, a seasoned partner in data analytics solutions.

Our mission was to

• Create a front end and back end for a diabetes management data analytics and reporting system. 

• Carry out the appropriate integrations with data sources for data ingestion.

• Conduct thorough testing, with coverage ranging from 70% to 100%, including unit tests and automation tests.

AiRo Created A HIPAA-Compliant Data-Driven Diabetes Management System

A HIPAA-compliant data-driven diabetes management system that gathers unprocessed data from the continuous glucose monitor and insulin pump and uses an ETL process to turn it into reports and insightful data that can help healthcare professionals make clinical decisions. The following are some of its primary features:

1. Report generation uses information gathered by the CGM and insulin pump every few minutes and a large number of algorithms to produce reports in a uniform format that complies with the industry’s stringent rules. Reports combine daily glucose readings into a single graph to highlight daily patterns and weekly summaries of crucial metrics, including average glucose, glucose variability, and time-in-range (the amount of time a person spends within the desired glucose range).

2. Clinicians-only portal linked to users’ electronic health records (EHR). Clinicians can select and update cases, print them off, and download them using its access to reports and patient management capability.

3. User insights are generated within the app based on the reports. They assist users in maintaining the desired glucose range by monitoring patterns. These insights include graphs displaying the glucose history and instances when the user’s blood sugar was inside or outside of the intended range.

The Client Records Significant Gains Post Deployment:

Users can easily track their glucose levels in real time between appointments without fingersticks, and the system provides them with in-app access to reports showing how they are doing. The data-driven diabetes management platform allows clinicians to make informed decisions about diagnosis, treatment selection, or treatment adjustments relying on unbiased CGM data collected under conditions of daily living.