Diabetes patients are increasingly using a continuous glucose sensor to monitor blood glucose and an insulin pump connected to an infusion cannula to administer insulin. Applying these devices requires two separate insertion sites, one for the sensor and one for the cannula. Integrating sensor with cannula to perform glucose sensing and insulin infusion through a single insertion site would significantly simplify and improve diabetes treatment by reducing the overall system size and the number of necessary needle pricks. Presently, several research groups are pursuing the development of combined glucose sensing and insulin infusion devices, termed single-port devices, by integrating sensing and infusion technologies created from scratch.
Instead of creating the device from scratch, we utilized already existing technologies and introduced three design concepts of integrating commercial glucose sensors and infusion cannulas. We prototyped and evaluated each concept according to design simplicity, ease of insertion, and sensing accuracy.
We found that the best single-port device is the one in which a Dexcom sensor is housed inside a Medtronic cannula so that its glucose sensitive part protrudes from the cannula tip. The low degree of component modification required to arrive at this configuration allowed us to test the efficiency and safety of the device in diabetes patients.
We found that the quality of the glucose sensing with the device is comparable to that with a control sensor both during a 6-day treatment period in the patients’ home environment and a closed-loop glucose control period over 24 hours at the clinical research center. Furthermore, insulin delivery with the device was reliable and safe during the 6-day home-use period and, when performed in combination with a control algorithm, was adequate to achieve and maintain near normoglycemia. These findings suggest the feasibility of combining commercial glucose sensing and insulin delivery technologies to realize a single-port device.
Development of a Single-Site Device for Conjoined Glucose Sensing and Insulin Delivery in Type 1 Diabetes Patients
Mathias Tschaikner, Amra Simic, Miro Jungklaus, Martin Fritz, Martin Ellmerer, Thomas R. Pieber, & Werner Regittnig
Novel Single-Site Device for Conjoined Glucose Sensing and Insulin Infusion: Performance Evaluation in Diabetes Patients During Home-Use
Mathias Tschaikner, Kevin Powell, Miró Jungklaus, Martin Fritz, Martin Ellmerer, Roman Hovorka, Steve Lane, Thomas R. Pieber, and Werner Regittnig