HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Garg, S. Articles by Jovanovic, L. Search for Related Content PubMed PubMed Citation Articles by Garg, S. Articles by Jovanovic, L. Social Bookmarking                What's this?

Improvement in Glycemic Excursions With a Transcutaneous, Real-Time Continuous Glucose Sensor

A randomized controlled trial

¹ Barbara Davis Center for Childhood Diabetes, University of Colorado Health Sciences Center, Denver, Colorado
² Sansum Diabetes Research Institute, Santa Barbara, California
³ Diabetes & Glandular Disease Research Associates, San Antonio, Texas
⁴ North County Endocrine Group, Escondido, California
⁵ East Bay Clinical Trial Center, Concord, California

Address correspondence and reprint requests to Satish Garg, MD, Professor of Medicine and Pediatrics, Barbara Davis Center for Childhood Diabetes, University of Colorado Health Sciences Center, 1775 N. Ursula St., A140, Aurora, CO 80010. E-mail: satish.garg{at}uchsc.edu

OBJECTIVE—Hypoglycemia and wide glucose excursions continue to be major obstacles to achieving target HbA_1c values and the associated reductions in long-term complications (and economic costs) in people with insulin-treated diabetes. In this study we evaluated the accuracy, safety, and clinical effectiveness of a continuous glucose-sensing device.

RESEARCH DESIGN AND METHODS—A total of 91 insulin-requiring patients with type 1 (n = 75) and type 2 (n = 16) diabetes were enrolled in this multicenter randomized study. Subjects wore a transcutaneous, 3-day, continuous glucose-sensing system for three consecutive 72-h periods. Subjects were randomly assigned (1:1 ratio) to either a control group (continuous glucose data not provided) or a display group (continuous glucose data not provided during period 1 but displayed during periods 2 and 3). During periods 2 and 3, patients in the display group had real-time access to sensor glucose values, could review glucose trends over the preceding 1, 3, and 9 h, and were provided with high (200 mg/dl) and low (80 mg/dl) alerts and a low (55 mg/dl) alarm. Sensors were inserted by patients, and both groups used (or wore) the system during daily activities. Device accuracy was assessed by comparing continuous glucose values to paired self-monitoring of blood glucose (SMBG) meter readings. Clinical effectiveness was evaluated by analyzing between-group (control vs. display, periods 2 and 3) and within-group (display, period 1 vs. period 3) differences in time spent in high, low, and target (81–140 mg/dl) glucose zones.

RESULTS—When prospective, real-time sensor values were compared with SMBG values, 95.4% of 6,767 paired glucose values fell within Clarke error grid A and B zones. Pearson’s correlation coefficient was 0.88, and mean and median absolute relative differences were 21.2 and 15.9%, respectively. No systematic bias was detected at any of the prespecified glucose levels (50, 80, 100, 150, and 200 mg/dl). When compared with control subjects, the display group spent 21% less time as hypoglycemic (<55 mg/dl), 23% less time as hyperglycemic (240 mg/dl), and 26% more time in the target (81–140 mg/dl) glucose range (P < 0.001 for each comparison). Nocturnal (10:00 P.M. to 6:00 A.M.) hypoglycemia, as assessed at two thresholds, was also reduced by 38% (<55 mg/dl; P < 0.001) and 33% (55–80 mg/dl; P < 0.001) in the display group compared with control subjects.

CONCLUSIONS—We conclude that real-time continuous glucose monitoring for periods up to 72 h is accurate and safe in insulin-requiring subjects with type 1 and type 2 diabetes. This study demonstrates that availability of real-time, continuously measured glucose levels can significantly improve glycemic excursions by reducing exposure to hyperglycemia without increasing the risk of hypoglycemia, which may reduce long-term diabetes complications and their associated economic costs.

Abbreviations: ARD, absolute relative difference • DCCT, Diabetes Control and Complications Trial • SMBG, self-monitoring of blood glucose

CiteULike    Del.icio.us    Digg    Reddit    Technorati    What's this?