The collaboration enables the integration of Tandem’s t:slim X2 and Mobi AID systems with Clinical Ink’s GlucoseReady platform. This would provide an automated method for capturing AID system data in clinical trials.
In the partnership, type 1 diabetes patients who opt into a study will have their basal and bolus insulin data securely recorded from their Tandem pumps and transmitted directly into the GlucoseReady platform. Data may remain blinded to participants but can become available to the sponsor.
Clinical Ink said the integration complements its existing GlucoseReady capabilities. Those include capturing CGM, blood glucose monitoring (BGM) and other digital biomarkers.
The companies believe their integration addresses a clinical need for accurate, real-time AID data in type 1 diabetes clinical research. They hope to reduce reliance on manual reporting and improve data integrity. By automating the process, they hope to streamline trial workflows, enhance patient experience and support regulatory compliance.
Commentary from Clinical Ink and Tandem Diabetes Care officials
Dr. Jonathan Goldman, CEO of Clinical Ink, said:
“Our partnership with Tandem Diabetes Care represents a significant step forward in the evolution of clinical trials in type 1 diabetes. By combining insulin delivery data with CGM and patient-reported outcomes in a single GCP-compliant platform, we enable sponsors to achieve additional transparency and accuracy. This integration strengthens patient engagement and retention, both of which are important in type 1 diabetes.”
Dr. Jordan Pinsker, Tandem chief medical officer, said:
“We are pleased to be working with Clinical Ink on this initiative. This collaboration sets a new precedent for type 1 diabetes research, and we are proud to see our market-leading advanced insulin delivery systems represented as part of this effort.
