Safety and Performance of the Omnipod Hybrid Closed-Loop System in Adults, Adolescents, and Children with Type 1 Diabetes Over 5 Days Under Free-Living Conditions.

The objective of this study was to assess the safety and performance of the Omnipod personalized model predictive control (MPC) algorithm in adults, adolescents, and children aged ≥6 years with type 1 diabetes (T1D) under free-living conditions using an investigational device. A 96-h hybrid closed-loop (HCL) study was conducted in a supervised hotel/rental home setting following a 7-day outpatient standard therapy (ST) phase. Eligible participants were aged 6-65 years with A1C <10.

Performance of Omnipod Personalized Model Predictive Control Algorithm with Moderate Intensity Exercise in Adults with Type 1 Diabetes.

The objective of this study was to assess the safety and performance of the Omnipod personalized model predictive control (MPC) algorithm with variable glucose setpoints and moderate intensity exercise using an investigational device in adults with type 1 diabetes (T1D). A supervised 54-h hybrid closed-loop (HCL) study was conducted in a hotel setting after a 7-day outpatient standard treatment phase. Adults aged 18-65 years with T1D and HbA1c between 6.

Performance of the Omnipod Personalized Model Predictive Control Algorithm with Meal Bolus Challenges in Adults with Type 1 Diabetes.

Background: This study assessed the safety and performance of the Omnipod personalized model predictive control (MPC) algorithm using an investigational device in adults with type 1 diabetes in response to overestimated and missed meal boluses and extended boluses for high-fat meals.

Materials And Methods: A supervised 54-h hybrid closed-loop (HCL) study was conducted in a hotel setting after a 7-day outpatient open-loop run-in phase. Adults aged 18-65 years with type 1 diabetes and HbA1c 6.

Safety and Feasibility of the OmniPod Hybrid Closed-Loop System in Adult, Adolescent, and Pediatric Patients with Type 1 Diabetes Using a Personalized Model Predictive Control Algorithm.

Background: The safety and feasibility of the OmniPod personalized model predictive control (MPC) algorithm in adult, adolescent, and pediatric patients with type 1 diabetes were investigated.

Methods: This multicenter, observational trial included a 1-week outpatient sensor-augmented pump open-loop phase and a 36-h inpatient hybrid closed-loop (HCL) phase with announced meals ranging from 30 to 90 g of carbohydrates and limited physical activity. Patients aged 6-65 years with HbA1c between 6.

Application of Glycemic Variability Percentage: Implications for Continuous Glucose Monitor Utilization and Analysis of Artificial Pancreas Data.

Background: The problem of glycemic variability has been widely acknowledged in patients with diabetes with severe insulin deficiency. In a companion article, we proposed a novel metric, the glycemic variability percentage (GVP), for assessing glycemic variability that accounts for both the amplitude and frequency of glycemic fluctuations.

Method: We applied the new metric, the GVP, to a previously reported case of a subject using an earlier generation continuous glucose monitoring (CGM) device, in which successive periods of use were associated with an apparent decrease in glycemic variability.

Glycemic Variability Percentage: A Novel Method for Assessing Glycemic Variability from Continuous Glucose Monitor Data.

Background: High levels of glycemic variability are still observed in most patients with diabetes with severe insulin deficiency. Glycemic variability may be an important risk factor for acute and chronic complications. Despite its clinical importance, there is no consensus on the optimum method for characterizing glycemic variability.

A Simple Composite Metric for the Assessment of Glycemic Status from Continuous Glucose Monitoring Data: Implications for Clinical Practice and the Artificial Pancreas.

Background: The potential clinical benefits of continuous glucose monitoring (CGM) have been recognized for many years, but CGM is used by a small fraction of patients with diabetes. One obstacle to greater use of the technology is the lack of simplified tools for assessing glycemic control from CGM data without complicated visual displays of data.

Methods: We developed a simple new metric, the personal glycemic state (PGS), to assess glycemic control solely from continuous glucose monitoring data.

Are Systematic Reviews and Meta-Analyses Appropriate Tools for Assessing Evolving Medical Device Technologies?

Systematic reviews and meta-analyses (SRMAs) provide unique insights into comparative effectiveness of diabetes treatments. However, use of these analyses may be inappropriate for assessing the value and utility of technologies that involve significant behavioral interventions and encompass rapidly evolving technologies such as real-time continuous glucose monitoring (RT-CGM). The rapid evolution of RT-CGM, compared with the time required for publication of clinical studies used in SRMAs, may preclude differentiation between past and current generations of devices.

Hypoglycemic Accuracy and Improved Low Glucose Alerts of the Latest Dexcom G4 Platinum Continuous Glucose Monitoring System.

Objective: Accuracy of continuous glucose monitoring (CGM) devices in hypoglycemia has been a widely reported shortcoming of this technology. We report the accuracy in hypoglycemia of a new version of the Dexcom (San Diego, CA) G4 Platinum CGM system (software 505) and present results regarding the optimum setting of CGM hypoglycemic alerts.

Materials And Methods: CGM values were compared with YSI analyzer (YSI Life Sciences, Yellow Springs, OH) measurements every 15 min.

Numerical simulation of the effect of rate of change of glucose on measurement error of continuous glucose monitors.

Background: A 5-day in-patient study designed to assess the accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System revealed that the level of accuracy of the continuous sensor measurements was dependent on the rate of glucose change. When the absolute rate of change was less than 1 mg*dl(-1)*min(-1) (75% of the time), the median absolute relative difference (ARD) was 8.5%, with 85% of all points falling within the A zone of the Clarke error grid.

Accuracy of the 5-day FreeStyle Navigator Continuous Glucose Monitoring System: comparison with frequent laboratory reference measurements.

Objective: The purpose of this study was to compare the accuracy of measurements of glucose in interstitial fluid made with the FreeStyle Navigator Continuous Glucose Monitoring System with Yellow Springs Instrument laboratory reference measurements of venous blood glucose.

Research Design And Methods: Fifty-eight subjects with type 1 diabetes, aged 18-64 years, were enrolled in a multicenter, prospective, single-arm study. Each subject wore two sensors simultaneously, which were calibrated with capillary fingerstick measurements at 10, 12, 24, and 72 h after insertion.

Rhenium bipyridine complexes for the recognition of glucose.

Bipyridine ligands containing pendant methyl, amino, and amino-boronic acid groups were synthesized. Coordination complexes of these ligands with rhenium were prepared straightforwardly and in good yield. The fluorescence behavior of the Re complexes was studied as a function of pH and exposure to various concentrations of glucose.