Julia K. Mader, Austria
Medical University of Graz Division of Endocrinology and DiabetologyPresenter of 4 Presentations
Introduction
Personalising insulin therapy using smart pumps, pens and automated insulin delivery systems
Discussion & Closing
GLUCOSE TRACKING WITH OPTICAL MEASUREMENT IN CLINICAL EVALUATION—PROFUSA LUMEE GLUCOSE PLATFORM
- Julia K. Mader, Austria
- Amra Simic, Austria
- Marvin J. Roosen, Austria
- Matthias Hartmann, Austria
- Lara K. Scholle, Austria
- Rebecca Siegl, Austria
- Sona Vardanyan, Austria
- Tina Pöttler, Austria
- Wayne Menzie, United States of America
- Soya Gamsey, United States of America
- Kerstin Rebrin, United States of America
- Ulrike Kamecke, United States of America
Abstract
Background and Aims
Profusa is developing a soft glucose-sensitive hydrogel, a sterile, small (5.0x0.75x0.65mm when hydrated), intended for subcutaneous injection. The hydrogel is suitable for long term use and could remain in the body permanently. Presented studies assess the platform function, transitioning from animal studies to human studies.
Methods
The glucose sensor is comprised of a hydrogel scaffold with covalently bound fluorescent molecules that produce near infrared light proportional to glucose concentration when interrogated by an optical reader placed on the skin (Figure 1). The v3.0 Reader utilizes a set of LEDs to excite fluorophores within the Hydrogel. The LEDs reside in the Reader which sits on the skin above the Hydrogel. The reader communicates wirelessly to a tablet for control and data transmission (Figure 2). Pre-clincal performance was validated in a swine mode in multiple 8-hour experiments over 3 months.Performance was assessed during in-clinic visits in subjects with diabetes over a period of 3 months. Frequent blood glucose measurements with a Super GL laboratory analyzer were collected as reference.
Results
This study was designed to characterize baseline performance and signal perturbations due to environmental conditions, including motion, temperature, and ambient light. This characterization is used to develop and refine the signal processing algorithm to calculate glucose levels.The following graphs (Figures 3-5) demonstrate the successful identification of a glucose excursion in a single subject during the first two weeks.
Conclusions
Results of using this hydrogel and reader in the swine model are confirmed in this clinical study, tracking glucose during study days over a 3-month period.
Moderator of 1 Session
Advancing value-based personalised diabetes care in challenging time - Industry Symposium Supported by Roche