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Randomized controlled trial to assess the impact of continuous glucose monitoring on HbA1cin insulin-treated diabetes (MITRE Study)

Cooke, D., Hurel, S. J., Casbard, Angela C., Steed, L., Walker, S., Meredith, S., Nunn, A. J., Manca, A., Sculpher, M., Barnard, M., Kerr, D., Weaver, J. U., Ahlquist, J. and Newman, S. P. 2009. Randomized controlled trial to assess the impact of continuous glucose monitoring on HbA1cin insulin-treated diabetes (MITRE Study). Diabetic Medicine 26 (5) , pp. 540-547. 10.1111/j.1464-5491.2009.02723.x

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Abstract

Aims To determine whether continuous glucose information provided through use of either the GlucoWatch G2 Biographer or the MiniMed continuous glucose monitoring system (CGMS) results in improved glycated haemoglobin (HbA1c) for insulin-treated adults with diabetes mellitus, relative to an attention control and standard care group. Methods Four hundred and four adults taking at least two daily insulin injections and with two consecutive HbA1c values ≥ 7.5% were recruited to this randomized controlled trial (RCT). All were trained at baseline to use the same monitor for traditional capillary glucose testing throughout the 18-month study. The CGMS group were asked to wear the device three times during the first 3 months of the trial and on another three occasions thereafter. The GlucoWatch group wore the device a minimum of four times per month and a maximum of four times per week during the first 3 months and as desired for the remainder of the trial. Trained diabetes research nurses used downloaded data to guide therapy adjustments. Proportional reduction in HbA1c from baseline to 18 months was the primary outcome measure. Results Neither an intention-to-treat nor per-protocol analysis showed improvement in HbA1c in the device groups compared with standard care. For the intention-to-treat analysis, when the standard care group was compared with each of the other groups, this equated to differences in mean relative HbA1c reduction (95% confidence interval) from baseline to 18 months of 3.5% (−1.3 to 8.3; GlucoWatch), 0.7% (−4.1 to 5.5; CGMS), and −0.1% (−4.6 to 4.3; attention control). Conclusions The additional information provided by these devices did not result in improvements in HbA1c in this population.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Subjects: R Medicine > R Medicine (General)
Uncontrolled Keywords: continuous glucose monitoring
Publisher: Wiley
ISSN: 0742-3071
Last Modified: 04 Jun 2017 03:47
URI: http://orca.cf.ac.uk/id/eprint/26864

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