Glooko Research 1.14.3

The platform under review is a noteworthy virtual ecosystem designed to meet FDA Part 11 and HIPAA compliance, currently operating roughly 4,700 active sites across 26 countries and serving approximately 300,000 patients on a monthly basis.

Glooko effectively enhances the digital health landscape by facilitating connections between individuals with diabetes and their healthcare providers. This integration allows for telehealth services, clinical research opportunities, and promotes improved collaboration within healthcare teams. The platform excels in data collection, synthesizing information from various devices, including blood glucose meters, continuous glucose monitors (CGMs), insulin pumps, pens, and activity trackers to provide actionable insights in a single location.

• Renowned leaders in diabetes care rely on Glooko's innovative solutions.
• Over 2.8 million users have gained valuable insights into their diabetes management.
• Individuals with diabetes and their healthcare teams benefit from Glooko's offerings in 26 countries and in 15 different languages.

Features

• Real-World Data Sources: The platform integrates data from blood glucose meters (BGMs), CGMs, insulin pumps, smart pens, health applications, electronic health records (EHRs), electronic data capture (EDC) systems via API, and lifestyle devices.

Secure Data Collection and Analytics:

• Enables synchronization of blood glucose, medication, and fitness data through Bluetooth and Apple Health.
• Facilitates secure remote participant data uploads and monitoring.
• Offers data analytics capabilities that aggregate information from connected devices for direct export to EDC systems.
• Ensures HIPAA compliant secure data transmission through API or FTP.

Digital Remote Solutions for Participants:

• Glooko(R) Mobile App
• Glooko Mobile Insulin Dosing System (MIDS) - FDA cleared
• Glooko Remote Patient Monitoring

Digital Remote Solutions for Investigators:

• Glooko(R) Population Tracker
• Scheduled clinic population health reporting

Trial Management Tools and Support:

• A participant monitoring platform designed for use before, during, and after interventions.
• Comprehensive study project management tools.
• Dedicated clinical support for trial activities.

*Future development is anticipated.