Effectiveness of Continuous Glucose Monitoring in a Clinical Care Environment
Evidence from the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring (JDRF-CGM) trial
- Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group*
- Corresponding author: Roy W. Beck, jdrfapp{at}jaeb.org.
Abstract
OBJECTIVE To determine whether continuous glucose monitoring (CGM) is effective in the management of type 1 diabetes when implemented in a manner that more closely approximates clinical practice.
RESEARCH DESIGN AND METHODS After completion of a 6-month randomized controlled trial (RCT) evaluating CGM in children, adolescents, and adults with type 1 diabetes, CGM was initiated in the trial's control group with less intensive training and follow-up than was included in the RCT. Subjects had an outpatient training session, two follow-up phone calls, and outpatient visits at 1, 4, 13, and 26 weeks. For subjects with baseline A1C ≥7.0%, the primary outcome was change in A1C at 6 months.
RESULTS CGM use decreased from a median of 7.0 days/week in the first month in the ≥25-year-old group, 6.3 days/week in the 15–24 year olds, and 6.8 days/week in the 8–14 year olds to 6.5, 3.3, and 3.7 days/week in the 6th month, respectively (P < 0.001 for each age-group). Among subjects with baseline A1C ≥7.0%, CGM use was associated with A1C reduction after 6 months (P = 0.02 adjusted for age-group). Severe hypoglycemia decreased from 27.7 events per 100 person-years in the 6-month control phase of the RCT to 15.0 events per 100 person-years in the 6-month follow-up CGM phase (P = 0.08).
CONCLUSIONS Frequent use of CGM in a clinical care setting may improve A1C and reduce episodes of hypoglycemia. However, sustained frequent use of CGM is less likely in children and adolescents than in adults.
Footnotes
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↵*The list of members of the Writing Committee can be found in the appendix, and a complete list of the members of the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group is available in an online appendix at http://care.diabetesjournals.org/cgi/content/full/dc09-1502/DC1.
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The study was designed and conducted by the investigators, who collectively wrote the manuscript and vouch for the data. The investigators had complete autonomy to analyze and report the trial results. There were no agreements concerning confidentiality of the data between the Juvenile Diabetes Research Foundation and the authors or their institutions. The Jaeb Center for Health Research had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
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The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.
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- Received August 12, 2009.
- Accepted October 5, 2009.
- © 2010 by the American Diabetes Association.
