Combining an Electrochemical Continuous Glucose Sensor With an Insulin Delivery Cannula: A Feasibility Study.

Background: Combining a continuous glucose monitor with an insulin delivery cannula (CGM-IS) could benefit clinical outcomes. We evaluated the feasibility of a single-needle insertion electrochemical investigational CGM-IS (Pacific Diabetes Technologies, Portland, Oregon) in type 1 diabetes adults.

Methods: Following 48 hours run-in using a Medtronic 780G in manual mode with a commercial insulin set, 12 participants commenced insulin delivery using the CGM-IS.

A Prospective Multicenter Clinical Performance Evaluation of the C-CGM System.

Background: Continuous glucose monitors (CGMs) have had a significant impact on the management of diabetes mellitus. We present the results of a multinational evaluation of the Cascade CGM ("C-CGM") over 14 days of in-clinic and home use.

Method: Each of the 57 enrolled type 1 diabetes mellitus and type 2 diabetes mellitus subjects wore 2 C-CGMs on the abdomen for 14 days.

A label-free fiber-optic Turbidity Affinity Sensor (TAS) for continuous glucose monitoring.

In this paper, we describe the concept of a novel implantable fiber-optic Turbidity Affinity Sensor (TAS) and report on the findings of its in-vitro performance for continuous glucose monitoring. The sensing mechanism of the TAS is based on glucose-specific changes in light scattering (turbidity) of a hydrogel suspension consisting of small particles made of crosslinked dextran (Sephadex G100), and a glucose- and mannose-specific binding protein - Concanavalin A (ConA). The binding of ConA to Sephadex particles results in a significant turbidity increase that is much greater than the turbidity contribution by the individual components.

Acute in vivo performance evaluation of the fluorescence affinity sensor in the intravascular and interstitial space in Swine.

Objective: We assessed and compared the performance levels of a fiber-coupled fluorescence affinity sensor (FAS) for glucose detection in the intradermal tissue and intravascular bed during glucose clamping and insulin administration in a large animal model.

Research Design And Methods: The FAS (BioTex Inc., Houston, TX) was implanted in interstitial tissue and in the intravenous space in nondiabetic, anesthetized pigs over 6-7 h.

A human pilot study of the fluorescence affinity sensor for continuous glucose monitoring in diabetes.

Objective: We report results of a pilot clinical study of a subcutaneous fluorescence affinity sensor (FAS) for continuous glucose monitoring conducted in people with type 1 and type 2 diabetes. The device was assessed based on performance, safety, and comfort level under acute conditions (4 h).

Research Design And Methods: A second-generation FAS (BioTex Inc.

Preclinical in vivo study of a fluorescence affinity sensor for short-term continuous glucose monitoring in a small and large animal model.

Background: The performance of a fiber-coupled fluorescence affinity sensor (FAS) was studied in vivo in small and large animal models, in order to assess its feasibility and safety for short-term glucose monitoring in humans.

Methods: Determination of interstitial glucose concentrations in skin tissue of hairless rats and small pigs was facilitated by measuring the fluorescence response of the implanted FAS over several hours and multiple days. Blood sugar changes in animals were induced by injections of insulin and dextrose.