First study to utilize CGM data with FDA-cleared, cloud-based titration software suggests significantly improved outcomes for patients while optimizing clinical resources
This past summer, Glytec published the first proof-of-concept study that combines FDA-cleared remote insulin titration software and data from continuous glucose monitoring (CGM) systems. Results of the study, presented at the American Diabetes Association’s 80th annual Scientific Sessions, showed a 26% increase in time in range for participants living with diabetes – an improvement from 48% at baseline to 74% after only four weeks of care.
The study evaluated 25 adults who used the Abbott Freestyle Libre CGM system and Abbott LibreLink app on their mobile phone. Patient data was provided to Glytec’s Glucommander software – a cloud-based, FDA-cleared solution for outpatient basal-bolus insulin titration. All participants met the criteria of living with Type 2 diabetes, reporting A1C levels > 8.0%, and owning a smartphone capable of running the LibreLink app.
The four-week study began with a nurse educator helping participants set up the Abbott Freestyle Libre 14-day CGM system while collecting baseline data. Participants went to the Atlanta Diabetes Associates office every two weeks for CGM sensor changes, and insulin titration was done during these visits or by phone on the weeks not requiring visits. To obtain updated doses, nurse educators reviewed participant CGM data, remotely generated dose updates from Glucommander, examined the recommendation and passed it on to the patient. No intervention by the licensed provider was necessary.
“This approach delivers significantly improved outcomes for patients on basal bolus insulin with multiple daily injections, while optimizing the use of clinical resources,” the authors conclude. “The combination of Glucommander software and CGM data can continually optimize insulin doses and improve outcomes while relieving the burden on patients and providers.”
“Many people with type 2 diabetes who have to administer multiple daily injections struggle to reach and maintain a target blood glucose level. But this study shows promising evidence that combining CGM data with titration software could significantly improve the ability for patients to reach a target range quicker than ever before with minimal intervention from their physician,” says Bruce Bode, MD, FACE, diabetes specialist at Atlanta Diabetes Associates, Adjunct Associate Professor of Medicine at Emory University School of Medicine and Glytec co-founder. “This study will pave the way for potential innovations that can improve the health and lifestyle of millions of people living with diabetes.”
Without a combined CGM and Glucommander approach, individuals living with diabetes in the outpatient setting rely on finger pricks and meters to measure blood glucose levels. Patients using these methods traditionally visit their provider every few months to adjust insulin dosing based on historical data, and can go years without achieving their optimal dosing regimen.
“This study suggests there is a simplified approach to blood glucose management that provides immediate results and relieves the burden on patients and providers,” says John Clarke, RN, CDCES, R&D, Clinical Support at Glytec. “CGM removes the need for painful finger pricks and provides a vast amount of data for Glucommander to create personalized insulin doses. Without the need for provider intervention, patients experience better outcomes and quality of life while doctors can focus their time and resources on high priority cases.”