Evaluation of factors affecting CGMS calibration.

Background: The optimal number/timing of calibrations entered into the CGMS (Medtronic MiniMed, Northridge, CA) continuous glucose monitoring system have not been previously described.

Methods: Fifty subjects with Type 1 diabetes mellitus (10-18 years old) were hospitalized in a clinical research center for approximately 24 h on two separate days. CGMS and OneTouch Ultra meter (LifeScan, Milpitas, CA) data were obtained.

Specular microscopy ancillary study methods for donor endothelial cell density determination of Cornea Donor Study images.

Purpose: To describe reliable methods for determining central corneal endothelial cell density (ECD) in a multicenter eye bank study.

Methods: The Specular Microscopy Reading Center utilized a dual-grading procedure and adjudication process to classify image quality and determine ECD for a subset of donor endothelial images obtained in the Specular Microscopy Ancillary Study, which is part of the Cornea Donor Study. Two certified readers classified images as analyzable (excellent, good, fair) or unanalyzable and determined the ECD using a variable frame technique.

Clinical profile and early surgical complications in the Cornea Donor Study.

Purpose: The Cornea Donor Study was designed to investigate the safety and efficacy of older donor corneal tissue compared with younger donor tissue in recipient eyes at moderate risk to the graft from progressive endothelial failure. Baseline patient data, including indications for transplant, intraoperative complication rates, and early postoperative complication rates are described herein.

Methods: This study was a multicenter prospective, double-masked, controlled clinical trial.

Response to nocturnal alarms using a real-time glucose sensor.

Background: The objective of this study was to determine how subjects responded to alarms for hypo- and hyperglycemia while they were sleeping.

Research Design And Methods: Twenty subjects with type 1 diabetes (4-17 years old) were admitted to a clinical research center for approximately 24 h. Each subject wore two GlucoWatch G2 Biographers (GW2B) (Cygnus, Inc.

An evaluation of image quality and accuracy of eye bank measurement of donor cornea endothelial cell density in the Specular Microscopy Ancillary Study.

Purpose: The Specular Microscopy Ancillary Study was designed to examine donor corneal endothelial specular image quality, compare the central endothelial cell density determined by eye banks with the endothelial cell density determined by a central specular microscopy reading center, and evaluate donor factors that may have an impact on specular image quality and endothelial cell density accuracy.

Design: Nonrandomized comparative trial.

Participants: Endothelial specular images of donor corneas assigned in the Cornea Donor Study.