Glooko Research vs T1D Trial

The world's most significant FDA Part 11 and HIPAA compliant virtual ecosystem: ~4,700 active monthly sites across 26 countries with ~300,000 patients per month. Glooko transforms digital health by connecting people with diabetes and their health care professionals, enabling telehealth, clinical research, and improved collaboration. We collect and unlock the power of data from blood-glucose meters, CGMs, insulin pumps, pens, and activity trackers – bringing insights together in one place. • World leaders trust Glooko solutions in diabetes care • 2.8 million users have benefited from diabetes data insights • People with diabetes and their health teams are benefiting from Glooko solutions in 26 countries across 15 languages FEATURES Real-World Data sources: BGMs/CGMs, pumps, smart pens, health apps, EHR*, EDC integration API*, and lifestyle devices. Secure Data Collection and Analytics: • Ability to sync blood glucose, medication, and fitness data via bluetooth and Apple Health. • Secure remote participate data upload and monitoring • Data analytics-aggregation of connected device data for direct export to EDC. • HIPAA compliant secure data transmission via API or FTP Digital Remote Solutions (Participant): • Glooko(R) Mobile App • Glooko Mobile Insulin Dosing System (MIDS) - FDA cleared • Glooko Remote Patient Monitoring Digital Remote Solutions (Investigator): • Glooko(R) Population Tracker • Scheduled clinic population health reporting Trial Management Tools and Support: • Participant monitoring platform (before/during/after intervention) • Study project management • Trial clinical support *Future development

The purpose of this study is to learn more about the safety and tolerability of an investigational product in people with Type 1 Diabetes and impaired awareness of hypoglycemia (low blood sugar).  The goal is to try to provide replacement cells for the ones that are lost or don’t work properly in people with diabetes.