Association between albuminuria and duration of diabetes and myocardial dysfunction and peripheral arterial disease among patients with stable coronary artery disease in the BARI 2D study.

Objective: To evaluate the effect of prior duration of diabetes, glycated hemoglobin level at study entry, and microalbuminuria or macroalbuminuria on the extent and severity of coronary artery disease (CAD) and peripheral arterial disease.

Patients And Methods: We studied baseline characteristics of the 2368 participants of the BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) study, a randomized clinical trial that evaluates treatment efficacy for patients with type 2 diabetes and angiographically documented stable CAD. Patients were enrolled from January 1, 2001, through March 31, 2005.

The Bypass Angioplasty Revascularization Investigation 2 Diabetes randomized trial of different treatment strategies in type 2 diabetes mellitus with stable ischemic heart disease: impact of treatment strategy on cardiac mortality and myocardial infarction.

Background: The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial in 2368 patients with stable ischemic heart disease assigned before randomization to percutaneous coronary intervention or coronary artery bypass grafting strata reported similar 5-year all-cause mortality rates with insulin sensitization versus insulin provision therapy and with a strategy of prompt initial coronary revascularization and intensive medical therapy or intensive medical therapy alone with revascularization reserved for clinical indication(s). In this report, we examine the predefined secondary end points of cardiac death and myocardial infarction (MI).

Methods And Results: Outcome data were analyzed by intention to treat; the Kaplan-Meier method was used to assess 5-year event rates.

The impact of minor adverse event tracking on subject safety: a web-based system.

BASED ON THE ASSUMPTION THAT MINOR symptoms may presage serious events, we report four years' experience with a web-based adverse event (AE) tracking system (eAETS) designed to capture AEs of a minor nature that would not meet criteria for ethical review. The eAETS has supported 175 diverse clinical protocols, is user-friendly and navigationally intuitive, and restricts access based on protocol ownership. The user creates an initial risk profile for comparison to subsequent AEs to identify unanticipated patterns.

Real-time glucose sensing using transdermal fluid under continuous vacuum pressure in children with type 1 diabetes.

Background: This study was designed to evaluate the accuracy and tolerance in children of an experimental device for continuous glucose monitoring. This real-time glucose sensing (RTGS) system measures transdermal fluid glucose through micropores in the stratum corneum that are kept open by continuous vacuum pressure.

Design And Methods: A comparison of self-monitored blood glucose values and RTGS values was obtained in 110 children with type 1 diabetes ranging in age from 2 to 18 years.

Glucose sensing in transdermal body fluid collected under continuous vacuum pressure via micropores in the stratum corneum.

Application of continuous vacuum pressure on skin perforated with tiny micropores created by a focused beam from a low-cost laser system can result in access to a clear, transdermal body fluid (TDF) for the continuous measurement of glucose in vivo. Two clinical studies were performed to assess the feasibility of this approach. In the first study, 56 diabetic subjects were porated on either the arm or abdomen, and glucose was measured in their TDF using a custom assay system contained in a patch that was affixed to the skin above the poration site.