Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Steven Hurel
ORCID ID
Contact details
Diabetes & Endocrinology
University College London Hospitals Foundation Trust
Mortimer Street
London
W1T 3AA
United Kingdom
+44 (0)207 380 9029
s.hurel@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 01/13/03
Study information
Scientific title
Acronym
MITRE
Study hypothesis
Primary Objectives 1-3, Secondary Objectives 4-7:
1. To compare the benefits of the GlucoWatch and CGMS Minimed on glycemic control relative to conventional monitoring and an attention control.
2. To assess patient acceptability and ease of use of the new technologies.
3. To model the long-term health benefits and costs and cost-effectiveness of these technologies.
4. To assess the impact of the devices on health care utilisation for diabetes related illnesses e.g. hypoglycemia, ketosis.
5. To assess impact of monitoring devices on patient satisfaction with care, attitudes toward diabetes and quality of life.
6. To assess the extent to which demographic factors (e.g. age, ethnicity) and individual differences in health cognitions influence outcome.
7. To assess the reliability of the glucowatch in clinical practice using available data.
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Nutritional, metabolic and endocrine diseases: Diabetes
Intervention
Please note that, as of 14 January 2008, the anticipated start and end dates of this trial have been updated from 1 April 2002 and 31 March 2005 to 1 December 2002 and 31 August 2008, respectively.
Interventions:
This will be a 4 arm RCT:
Group 1. GlucoWatch
Group 2. Continuous Glucose Monitoring System (CGMS) Minimed
Group 3. Attention control with a frequency of nurse feedback sessions the same as Groups 1 and 2
Group 4. Standard care i.e. 6 monthly clinic review
Intervention type
Device
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/12/2002
Overall trial end date
31/08/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Diabetics
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Added as of 10/09/07: Accrual target: 400; Accrual count: 404
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/12/2002
Recruitment end date
31/08/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Diabetes & Endocrinology
London
W1T 3AA
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19476724
Publication citations
-
Results
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 with conventional monitoring in the management of insulin-treated diabetes mellitus (MITRE)., Health Technol Assess, 2009, 13, 28, iii-iv, ix-xi, 1-194, doi: 10.3310/hta13280.