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| A randomised controlled trial to compare minimally invasive glucose monitoring devices to conventional monitoring in the management of insulin-treated diabetes mellitus (MITRE) |
| Newman SP, Cooke D, Casbard A, Walker S, Meredith S, Nunn A, Steed L, Manca A, Sculpher M, Barnard M, Kerr D, Weaver J, Ahlquist J, Hurel SJ |
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Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Newman SP, Cooke D, Casbard A, Walker S, Meredith S, Nunn A, Steed L, Manca A, Sculpher M, Barnard M, Kerr D, Weaver J, Ahlquist J, Hurel SJ. A randomised controlled trial to compare minimally invasive glucose monitoring devices to conventional monitoring in the management of insulin-treated diabetes mellitus (MITRE) Health Technology Assessment 2009; 13(28): 1-216 Authors' objectives The objective of this study was to evaluate whether the additional information provided by two minimally invasive glucose monitors resulted in improved glycaemic control in people with poorly controlled insulin-requiring diabetes in both the long and medium term. In addition, the acceptability and health economic impact of the devices was assessed. Authors' conclusions The outcomes indicate that continuous glucose monitors as assessed in this study do not lead to improved clinical outcomes in unselected individuals with poorly controlled insulin-requiring diabetes. In addition, the data suggest that the additional information provided by the two continuous glucose monitoring devices in this study (CGMS and GlucoWatch) is not cost-effective for improving HbA1c in an unselected population with poorly controlled type 1 or type 2 diabetes. The findings also indicate that the two devices were accepted differently by participants. The GlucoWatch device was associated with a large number of side effects and its acceptability to participants was particularly low with only 20% of participants continuing to use the device at 18 months. On acceptability grounds alone the data suggest that the GlucoWatch technology assessed in this study will not be frequently used by individuals with diabetes. The findings emphasise the importance of examining acceptability, as devices may demonstrate clinical value, but if potential users find them unacceptable or choose not to use them then it is unlikely that they could be introduced into routine care. Future studies of continuous glucose monitoring devices should target specific subgroups for study such as poorly controlled type 1 patients with hypoglycaemia unawareness. The acceptability of these devices to participants and health-care professionals is an area that needs further research and should be included in studies of their potential clinical benefit. INAHTA brief and checklist Indexing Status Subject indexing assigned by CRD MeSH Biosensing Techniques; Blood Glucose; Blood Glucose Self-Monitoring; Diabetes Mellituss; Hyperglycemia; Hypoglycemia; Monitoring, Ambulatory; Monitoring, Physiologic Language Published English Country of organisation England Address for correspondence NETSCC, Health Technology Assessment, Alpha House, University of Southampton Science Park, Southampton, SO16 7NS UK Tel: +44 23 8059 5586 Email: hta@hta.ac.uk AccessionNumber 32009100055 Date abstract record published 17/06/2009 |
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