Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
11/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ctu.mrc.ac.uk/studies/mitre.asp

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 measures

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

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

http://www.dh.gov.uk/en/index.htm

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19476724

Publication citations

  1. 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.

Additional files

Editorial Notes