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Randomized controlled trial to assess the impact of continuous glucose monitoring on HbA 1c in insulin‐treated diabetes (MITRE Study)
Author(s) -
Cooke D.,
Hurel S. J.,
Casbard A.,
Steed L.,
Walker S.,
Meredith S.,
Nunn A. J.,
Manca A.,
Sculpher M.,
Barnard M.,
Kerr D.,
Weaver J. U.,
Ahlquist J.,
Newman S. P.
Publication year - 2009
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2009.02723.x
Subject(s) - medicine , randomized controlled trial , diabetes mellitus , confidence interval , insulin , continuous glucose monitoring , glycated haemoglobin , blood glucose self monitoring , clinical trial , physical therapy , surgery , type 2 diabetes , glycemic , endocrinology
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 (HbA 1c ) 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 HbA 1c 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 HbA 1c from baseline to 18 months was the primary outcome measure. Results Neither an intention‐to‐treat nor per‐protocol analysis showed improvement in HbA 1c 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 HbA 1c 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 HbA 1c in this population.