Novel Single-Site Device for Conjoined Glucose Sensing and Insulin Infusion: Performance Evaluation in Diabetes Patients During Home-Use

Abstract

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. Methods: 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. Results: 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 humans. Conclusion: Results from these studies indicate the feasibility of combining commercial glucose sensing and insulin delivery technologies to realize a functional single-port device. Significance: Our development approach may be generally useful to provide patients with innovative medical devices faster and at reduced costs.

Longevity of the novel ConvaTec infusion set with Lantern technology

“…Recent work by Tschaikner et al reveals that off‐the‐shelf CGM and infusion sets can be combined by running the sensor wire through the cannula 13 . With the sensor wire extending 6 mm through the infusion set cannula opening, the sensor glucose obtained from the single‐site device did not differ significantly from a separately worn CGM 14 …”

“…Several groups have attempted to combine a sensor and infusion set into one device, but it was not practical because of limited infusion set longevity. [11][12][13][14] Recent work by Tschaikner et al reveals that off-the-shelf CGM and infusion sets can be combined by running the sensor wire through the cannula. 13 With the sensor wire extending 6 mm through the infusion set cannula opening, the sensor glucose obtained from the single-site device did not differ significantly from a separately worn CGM.…”

“…13 With the sensor wire extending 6 mm through the infusion set cannula opening, the sensor glucose obtained from the single-site device did not differ significantly from a separately worn CGM. 14 The strengths of the current study include real-world use of a new infusion set. The participants encompassed users of different insulins, insulin pumps with different body compositions and experiences with infusion sets.…”

“…Thus, any attempt to create a combined sensor and insulin infusion set requires an infusion set with greater longevity. Several groups have attempted to combine a sensor and infusion set into one device, but it was not practical because of limited infusion set longevity 11–14 . Recent work by Tschaikner et al reveals that off‐the‐shelf CGM and infusion sets can be combined by running the sensor wire through the cannula 13 .…”

A Glucose‐Responsive Cannula for Automated and Electronics‐Free Insulin Delivery

“…To this end, significant efforts have been devoted to the development of closed-loop insulin delivery systems, or artificial pancreas (AP) systems, namely bioartificial AP technologies based on polymer-encapsulated islets/stem cells, [14][15][16] fully synthetic AP therapies based on insulin-releasing polymers, [17][18][19][20][21][22][23] and electromechanical AP systems based on a continuous glucose monitor (CGM) and computer-controlled algorithms connected to an insulin delivery device. [24][25][26][27] Since T1D occurs from a loss of function of ß cells, restoration of endogenous insulin secretions though bioartificial AP therapies is a promising approach to achieve optimal glycemic control, particularly since even small doses of endogenous insulin secretions in T1D patients lead to less frequent severe hypoglycemic episodes and fewer overall diabetes related complications. [28] Isolated islets transplanted to the liver via the portal vein have achieved years-long insulin independence in many patients.…”