Document Detail


Use of continuous glucose monitoring as an outcome measure in clinical trials.
MedLine Citation:
PMID:  23013201     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: Although developed to be a management tool for individuals with diabetes, continuous glucose monitoring (CGM) also has potential value for the assessment of outcomes in clinical studies. We evaluated using CGM as such an outcome measure.
RESEARCH DESIGN AND METHODS: Data were analyzed from six previously completed inpatient studies in which both CGM (Freestyle Navigator™ [Abbott Diabetes Care, Alameda, CA] or Guardian(®) [Medtronic, Northridge, CA]) and reference glucose measurements were available. The analyses included 97 days of data from 93 participants with type 1 diabetes (age range, 5-57 years; mean, 18 ± 12 years).
RESULTS: Mean glucose levels per day were similar for the CGM and reference measurements (median, 148 mg/dL vs. 143 mg/dL, respectively; P = 0.92), and the correlation of the two was high (r = 0.89). Similarly, most glycemia metrics showed no significant differences comparing CGM and reference values, except that the nadir glucose tended to be slightly lower and peak glucose slightly higher with reference measurements than CGM measurements (respective median, 59 mg/dL vs. 66 mg/dL [P = 0.05] and 262 mg/dL vs. 257 mg/dL [P = 0.003]) and glucose variability as measured with the coefficient of variation was slightly lower with CGM than reference measurements (respective median, 31% vs. 35%; P<0.001).
CONCLUSIONS: A reasonably high degree of concordance exists when comparing outcomes based on CGM measurements with outcomes based on reference blood glucose measurements. CGM inaccuracy and underestimation of the extremes of hyperglycemia and hypoglycemia can be accounted for in a clinical trial's study design. Thus, in appropriate settings, CGM can be a very meaningful and feasible outcome measure for clinical trials.
Authors:
Roy W Beck; Peter Calhoun; Craig Kollman
Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Diabetes technology & therapeutics     Volume:  14     ISSN:  1557-8593     ISO Abbreviation:  Diabetes Technol. Ther.     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-09-27     Completed Date:  2013-02-12     Revised Date:  2013-10-09    
Medline Journal Info:
Nlm Unique ID:  100889084     Medline TA:  Diabetes Technol Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  877-82     Citation Subset:  IM    
Affiliation:
Jaeb Center for Health Research, Tampa, Florida, USA. jdrfapp@jaeb.org
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Blood Glucose / metabolism*
Blood Glucose Self-Monitoring*
Child
Child, Preschool
Diabetes Mellitus, Type 1 / blood*,  drug therapy,  epidemiology
Female
Hemoglobin A, Glycosylated / metabolism
Humans
Hyperglycemia / blood*,  drug therapy,  epidemiology
Hypoglycemia / blood*,  drug therapy,  epidemiology
Male
Middle Aged
Outcome Assessment (Health Care)
Randomized Controlled Trials as Topic
Reproducibility of Results
Sensitivity and Specificity
Time Factors
Young Adult
Chemical
Reg. No./Substance:
0/Blood Glucose; 0/Hemoglobin A, Glycosylated; 0/hemoglobin A1c protein, human
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