Use of continuous glucose monitoring as an outcome measure in clinical trials.

ABSTRACT:

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

SUBMITTER: Beck RW 

PROVIDER: S-EPMC3459006 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature