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
Record ID 32009100055
English
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' recommendations: 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.
Authors' methods: Randomised controlled trial
Details
Project Status: Completed
URL for project: http://www.hta.ac.uk/1306
Year Published: 2009
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England, United Kingdom
MeSH Terms
  • Biosensing Techniques
  • Blood Glucose
  • Blood Glucose Self-Monitoring
  • Hyperglycemia
  • Hypoglycemia
  • Monitoring, Ambulatory
  • Monitoring, Physiologic
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: 2009 Queen's Printer and Controller of HMSO
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.