Progressive Acceleration of Insulin Exposure Over 7 Days of Infusion Set Wear.

Insulin exposure varies over 3 days of insulin infusion set (IIS) wear making day-to-day insulin dosing challenging for people with diabetes (PWD). Here we report insulin pharmacodynamic (PD) and pharmacokinetic (PK) data extending these observations to 7 days of IIS wear. PWD (A1C ≤8.

In Vivo Study of the Inflammatory Tissue Response Surrounding a Novel Extended-Wear Kink-Resistant Insulin Infusion Set Prototype Compared With a Commercial Control Over Two Weeks of Wear Time.

Background: Infusion set function remains the limiting factor of insulin pump therapy due to nonmetabolic complications. Here, we tested an investigational extended-wear infusion set prototype with a soft, angled, wire-reinforced cannula with three additional side holes, and compared failure mechanisms and tissue response with a commercial Teflon control.

Methods: A total of 48 Teflon and 48 prototype infusion sets were inserted subcutaneously every other day for 14 days in 12 swine and infused with dilute insulin.

Feasibility study of a prototype extended-wear insulin infusion set in adults with type 1 diabetes.

Aim: To assess the feasibility of a prototype insulin infusion set (IIS) for extended wear in adults with type 1 diabetes.

Materials And Methods: The prototype Capillary Biomedical investigational extended-wear IIS (CBX IIS) incorporates a soft, flexible, reinforced kink-resistant angled nylon-derivative cannula with one distal and three proximal ports to optimize insulin delivery. Twenty adult participants with type 1 diabetes established on insulin pump therapy used the CBX IIS for two 7-day test periods while wearing a Dexcom G5 continuous glucose monitor.

In vivo investigation of the tissue response to commercial Teflon insulin infusion sets in large swine for 14 days: the effect of angle of insertion on tissue histology and insulin spread within the subcutaneous tissue.

Objective: This study investigated the effects of the inflammatory tissue response (ITR) to an insulin infusion set (IIS) on insulin bolus spread over wear time, as well as the effect of cannula insertion angle on the ITR, bolus shape, and pump tubing pressure.

Research Design And Methods: Angled or straight IISs were inserted every other day for 14 days into the subcutaneous tissue of 11 swine and insulin was delivered continuously. Prior to euthanasia, a 70 µL bolus of insulin/X-ray contrast agent was infused while recording a pressure profile (peak tubing pressure, p; area under the pressure curve, AUC), followed by the excision of the tissue-catheter specimen.

Continuous intra-arterial blood glucose monitoring using quenched fluorescence sensing in intensive care patients after cardiac surgery: phase II of a product development study.

Purpose: Variations in blood glucose (BG), hyperglycaemia and hypoglycaemia are associated with adverse clinical outcomes in intensive care unit patients. Continuous glucose monitoring (CGM) offers the potential to improve BG control, leading to improved patient outcomes. In our product development study, we determined the safety and performance of the GluCath Intravascular CGM System for up to 48 hours in 20 patients admitted to the ICU after cardiac surgery.

Vascular Glucose Sensor Symposium: Continuous Glucose Monitoring Systems (CGMS) for Hospitalized and Ambulatory Patients at Risk for Hyperglycemia, Hypoglycemia, and Glycemic Variability.

Hyperglycemia, hypoglycemia, and glycemic variability have been associated with increased morbidity, mortality, length of stay, and cost in a variety of critical care and non-critical care patient populations in the hospital. The results from prospective randomized clinical trials designed to determine the risks and benefits of intensive insulin therapy and tight glycemic control have been confusing; and at times conflicting. The limitations of point-of-care blood glucose (BG) monitoring in the hospital highlight the great clinical need for an automated real-time continuous glucose monitoring system (CGMS) that can accurately measure the concentration of glucose every few minutes.

Use of an Intravascular Fluorescent Continuous Glucose Sensor in ICU Patients.

Background: Hyperglycemia and hypoglycemia are associated with adverse clinical outcomes in intensive care patients. In product development studies at 4 ICUs, the safety and performance of an intravascular continuous glucose monitoring (IV-CGM) system was evaluated in 70 postsurgical patients.

Methods: The GluCath System (GluMetrics, Inc) used a quenched chemical fluorescence mechanism to optically measure blood glucose when deployed via a radial artery catheter or directly into a peripheral vein.

Accuracy of Intra-arterial and Subcutaneous Continuous Glucose Monitoring in Postoperative Cardiac Surgery Patients in the ICU.

Background: The GluCath® intra-arterial continuous glucose monitoring (IA-CGM) system uses a novel quenched chemical fluorescence sensing mechanism to optically measure blood glucose when deployed in the radial artery. The aim of this study was to compare the accuracy of the IA-CGM and the FreeStyle Navigator® subcutaneous continuous glucose monitoring (SC-CGM) system with standard care.

Methods: After admission to the intensive care unit (ICU), the IA-CGM was inserted via a 20 gauge radial arterial study catheter and the SC-CGM was placed at the abdominal wall of postoperative cardiac surgery patients with an expected ICU length of stay > 24 hours.

Continuous intra-arterial blood glucose monitoring using quenched fluorescence sensing: a product development study.

Background: Continuous glucose monitoring (CGM) has the potential to improve the management of blood glucose (BG) and so improve patient safety and outcomes in intensive care units. The GluCath Intravascular CGM (IV-CGM) System (GluMetrics) uses a novel quenched chemical fluorescence sensing mechanism to measure BG.

Objective: We aimed to assess the safety and performance of the GluCath IV-CGM for a 24-hour period in 20 patients admitted to an ICU after cardiac surgery.

Use of an intravascular fluorescent continuous glucose sensor in subjects with type 1 diabetes mellitus.

Background: Stress hyperglycemia in the critically ill is associated with increased morbidity and mortality. Continuous glucose monitoring offers a solution to the difficulties of dosing intravenous insulin properly to maintain glycemic control. The purpose of this study was to evaluate an intravascular continuous glucose monitoring (IV-CGM) system with a sensing element based on the concept of quenched fluorescence.

Use of a novel fluorescent glucose sensor in volunteer subjects with type 1 diabetes mellitus.

Background: Stress hyperglycemia in the critically ill has been found to be associated with increased morbidity and mortality. Studies have found significant improvements in morbidity and mortality in postsurgical patients whose glucose levels were closely maintained in the euglycemic range. However, subsequent studies, in particular the Normoglycemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation (NICE-SUGAR) study, found no improvement in subjects with tight glycemic control.