DiAs web monitoring: a real-time remote monitoring system designed for artificial pancreas outpatient trials.

BACKGROUND: Developments in an artificial pancreas (AP) for patients with type 1 diabetes have allowed a move toward performing outpatient clinical trials. "Home-like" environment implies specific protocol and system adaptations among which the introduction of remote monitoring is meaningful. We present a novel tool allowing multiple patients to monitor AP use in home-like settings. METHODS: We investigated existing systems, performed interviews of experienced clinical teams, listed required features, and drew several mockups of the user interface. The resulting application was tested on the bench before it was used in three outpatient studies representing 3480 h of remote monitoring. RESULTS: Our tool, called DiAs Web Monitoring (DWM), is a web-based application that ensures reception, storage, and display of data sent by AP systems. Continuous glucose monitoring (CGM) and insulin delivery data are presented in a colored chart to facilitate reading and interpretation. Several subjects can be monitored simultaneously on the same screen, and alerts are triggered to help detect events such as hypoglycemia or CGM failures. In the third trial, DWM received approximately 460 data per subject per hour: 77% for log messages, 5% for CGM data. More than 97% of transmissions were achieved in less than 5 min. CONCLUSIONS: Transition from a hospital setting to home-like conditions requires specific AP supervision to which remote monitoring systems can contribute valuably. DiAs Web Monitoring worked properly when tested in our outpatient studies. It could facilitate subject monitoring and even accelerate medical and technical assessment of the AP. It should now be adapted for long-term studies with an enhanced notification feature.

Feasibility of outpatient fully integrated closed-loop control: first studies of wearable artificial pancreas.

OBJECTIVE: To evaluate the feasibility of a wearable artificial pancreas system, the Diabetes Assistant (DiAs), which uses a smart phone as a closed-loop control platform. RESEARCH DESIGN AND METHODS: Twenty patients with type 1 diabetes were enrolled at the Universities of Padova, Montpellier, and Virginia and at Sansum Diabetes Research Institute. Each trial continued for 42 h. The United States studies were conducted entirely in outpatient setting (e.g., hotel or guest house); studies in Italy and France were hybrid hospital-hotel admissions. A continuous glucose monitoring/pump system (Dexcom Seven Plus/Omnipod) was placed on the subject and was connected to DiAs. The patient operated the system via the DiAs user interface in open-loop mode (first 14 h of study), switching to closed-loop for the remaining 28 h. Study personnel monitored remotely via 3G or WiFi connection to DiAs and were available on site for assistance. RESULTS: The total duration of proper system communication functioning was 807.5 h (274 h in open-loop and 533.5 h in closed-loop), which represented 97.7% of the total possible time from admission to discharge. This exceeded the predetermined primary end point of 80% system functionality. CONCLUSIONS: This study demonstrated that a contemporary smart phone is capable of running outpatient closed-loop control and introduced a prototype system (DiAs) for further investigation. Following this proof of concept, future steps should include equipping insulin pumps and sensors with wireless capabilities, as well as studies focusing on control efficacy and patient-oriented clinical outcomes.

Sudden cardiac arrest due to subtotal absence of left-sided pericardium--case report and review of the literature.

Congenital absence of the pericardium is a very rare cardiac malformation, usually diagnosed fortuitously on autopsy or surgery. Symptoms related to these abnormalities are usually benign, and fatalities reported in the literature are almost exclusively secondary to herniation of the heart through a partial defect. We present the unusual case of a 44-year-old woman admitted for sudden cardiac arrest. Initial evaluation suggested acute anterior myocardial infarction, but further investigation ruled out coronary heart disease. No arrhythmia could be initiated on electrophysiological study, and absence of most of the left pericardium was confirmed by cardiac magnetic resonance imaging. After the exclusion of common etiologies such as idiopathic ventricular fibrillation, transient great vessel torsion due to hypermobility of the heart with secondary malignant arrhythmia was considered to be the most likely mechanism for the sudden cardiac arrest. A review of the available literature on clinical presentation, diagnostic tools, and therapeutic options is also presented.

Complete absence of precordial R waves due to absence of left-sided pericardium.

Poor R-wave progression (PRWP) in the precordial leads on random ECG is relatively frequent in the general population and includes a broad differential diagnosis. Here, we present for the first time a case of complete absence of precordial R waves associated with a prominent R wave in aVR due to the absence of the left-sided pericardium in a 44-year-old woman who experienced sudden cardiac death.