Performance of a Wearable Ring in Controlled Hypoxia: A Prospective Observational Study.

Background: Over recent years, technological advances in wearables have allowed for continuous home monitoring of heart rate and oxygen saturation. These devices have primarily been used for sports and general wellness and may not be suitable for medical decision-making, especially in saturations below 90% and in patients with dark skin color. Wearable clinical-grade saturation of peripheral oxygen (SpO) monitoring can be of great value to patients with chronic diseases, enabling them and their clinicians to better manage their condition with reliable real-time and trend data.

Mobile health: the power of wearables, sensors, and apps to transform clinical trials.

Mobile technology has become a ubiquitous part of everyday life, and the practical utility of mobile devices for improving human health is only now being realized. Wireless medical sensors, or mobile biosensors, are one such technology that is allowing the accumulation of real-time biometric data that may hold valuable clues for treating even some of the most devastating human diseases. From wearable gadgets to sophisticated implantable medical devices, the information retrieved from mobile technology has the potential to revolutionize how clinical research is conducted and how disease therapies are delivered in the coming years.

The Transformation of Diabetes Care Through the Use of Person-Centered Data.

The health care industry is undergoing a major transformation. Despite spending more on health care than any other country, the United States has not seen a commensurate improvement in the quality of care. Chronic disease management puts the greatest burden on the health care system with estimates suggesting that 3 of 4 health care dollars are spent on managing chronic disease.

Model-based sensor-augmented pump therapy.

Background: In insulin pump therapy, optimization of bolus and basal insulin dose settings is a challenge. We introduce a new algorithm that provides individualized basal rates and new carbohydrate ratio and correction factor recommendations. The algorithm utilizes a mathematical model of blood glucose (BG) as a function of carbohydrate intake and delivered insulin, which includes individualized parameters derived from sensor BG and insulin delivery data downloaded from a patient's pump.

Continuous glucose monitoring considerations for the development of a closed-loop artificial pancreas system.

Background: Commercialization of a closed-loop artificial pancreas system that employs continuous subcutaneous insulin infusion and interstitial fluid glucose sensing has been encumbered by state-of-the-art technology. Continuous glucose monitoring (CGM) devices with improved accuracy could significantly advance development efforts. However, the current accuracy of CGM devices might be adequate for closed-loop control.

Accuracy of the Enlite 6-day glucose sensor with guardian and Veo calibration algorithms.

Objective: This study investigates the accuracy of a newly developed, next-generation subcutaneous glucose sensor, evaluated for 6-day use.

Research Design And Methods: Seventy-nine subjects (53 men, 26 women) with type 1 diabetes and 18 subjects (14 men, four women) with type 2 diabetes completed a three-center, prospective, sensor accuracy study. The mean age for the group was 42.

The pathway to the closed-loop artificial pancreas: research and commercial perspectives.

Background: Over the past decades, insulin pumps (CSII) and continuous glucose monitoring (CGM) systems have been combined in sensor augmented pump therapy. In addition, artificial pancreas (AP) research has progressed to clinical studies, using combinations of commercially available devices.

Objective: Sensor augmented pump therapy has been evaluated in a number of clinical trials.

Accuracy of a new real-time continuous glucose monitoring algorithm.

Background: Through minimally invasive sensor-based continuous glucose monitoring (CGM), individuals can manage their blood glucose (BG) levels more aggressively, thereby improving their hemoglobin A1c level, while reducing the risk of hypoglycemia. Tighter glycemic control through CGM, however, requires an accurate glucose sensor and calibration algorithm with increased performance at lower BG levels.

Methods: Sensor and BG measurements for 72 adult and adolescent subjects were obtained during the course of a 26-week multicenter study evaluating the efficacy of the Paradigm REAL-Time (PRT) sensor-augmented pump system (Medtronic Diabetes, Northridge, CA) in an outpatient setting.

Delays in minimally invasive continuous glucose monitoring devices: a review of current technology.

Through the use of enzymatic sensors-inserted subcutaneously in the abdomen or ex vivo by means of microdialysis fluid extraction-real-time minimally invasive continuous glucose monitoring (CGM) devices estimate blood glucose by measuring a patient's interstitial fluid (ISF) glucose concentration. Signals acquired from the interstitial space are subsequently calibrated with capillary blood glucose samples, a method that has raised certain questions regarding the effects of physiological time lags and of the duration of processing delays built into these devices. The time delay between a blood glucose reading and the value displayed by a continuous glucose monitor consists of the sum of the time lag between ISF and plasma glucose, in addition to the inherent electrochemical sensor delay due to the reaction process and any front-end signal processing delays required to produce smooth traces.

Putative delays in interstitial fluid (ISF) glucose kinetics can be attributed to the glucose sensing systems used to measure them rather than the delay in ISF glucose itself.

Background: Since the advent of subcutaneous glucose sensors, there has been intense focus on characterizing the delay in the interstitial fluid (ISF) glucose response and the effect of insulin to alter the plasma-to-ISF glucose gradient. The Medtronic MiniMed continuous glucose monitoring system (CGMS) has often been used for this purpose; however, many of the studies have used experimental conditions that fall outside its intended use, for example, studies that have assessed the delay during rapid glucose excursions brought about by intravenous infusion of glucose or insulin. Under these conditions, it is possible that the rate of glucose change may exceed that allowed by CGMS filtering routines.

Metabolic modelling and the closed-loop insulin delivery problem.

The approach used by Medtronic MiniMed to close the insulin delivery loop using the subcutaneous site for both glucose sensing and insulin delivery relies on modeling insulin action and beta-cell insulin secretion. This approach is contrasted with traditional control systems engineering.

Clinical experience with an integrated continuous glucose sensor/insulin pump platform: a feasibility study.

The recent US Food and Drug Administration approval of an integrated real-time continuous glucose monitoring (CGM) system and insulin pump (Medtronic Mini-Med Paradigm REAL-Time System; Medtronic MiniMed, Inc., Northridge, Calif) is the most recent breakthrough paving the way toward the development of a closedloop insulin delivery system that could revolutionize diabetes care. An early prototype of the MiniMed Paradigm REAL-Time System--which provided both realtime CGM and insulin pump therapy but was not yet fully integrated--was tested in 20 volunteer subjects with type 1 diabetes who wore the device for up to 2 y.

The use of a continuous glucose monitoring system in hypoglycemic disorders.

Objective: To evaluate the use of a continuous glucose monitoring system (CGMS) in the evaluation and treatment of infants and children with hypoglycemic disorders.

Methods: Patients with hypoglycemic disorders wore the CGMS device in the Pediatric Clinic Research Center during their evaluation and treatment. Capillary blood glucose (CBG) values were obtained at least 3 times each day and entered into the device for calibration purposes.