|
ISRCTN
|
ISRCTN33678610
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A randomised controlled trial (RCT) to compare minimally invasive glucose monitoring devices to conventional monitoring in the management of insulin treated diabetes mellitus.
|
|
Scientific title
|
|
|
Acronym
|
MITRE
|
|
Serial number at source
|
HTA 01/13/03
|
|
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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Nutritional, metabolic and endocrine diseases: Diabetes
|
|
Participants - inclusion criteria
|
Diabetics
|
|
Participants - exclusion criteria
|
Not provided at time of registration.
|
|
Anticipated start date
|
01/12/2002
|
|
Anticipated end date
|
31/08/2008
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Added as of 10/09/07: Accrual target: 400; Accrual count: 404
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Not provided at time of registration.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration.
|
|
Sources of funding
|
NIHR Health Technology Assessment Programme - HTA (UK)
|
|
Trial website
|
http://www.ctu.mrc.ac.uk/studies/mitre.asp
|
|
Publications
|
|
|
Contact name
|
Dr
Steven
Hurel
|
|
Address
|
Diabetes & Endocrinology
University College London Hospitals Foundation Trust
Mortimer Street
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1T 3AA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)207 380 9029
|
|
Fax
|
+44 (0)207 380 9479
|
|
Email
|
s.hurel@ucl.ac.uk
|
|
Sponsor
|
Department of Health (UK)
|
|
Address
|
Quarry House
Quarry Hill
|
|
City/town
|
Leeds
|
|
Zip/Postcode
|
LS2 7UE
|
|
Country
|
United Kingdom
|
|
Email
|
Sheila.Greener@doh.gsi.gov.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/en/index.htm
|
|
Date applied
|
25/04/2003
|
|
Last edited
|
14/01/2008
|
|
Date ISRCTN assigned
|
25/04/2003
|
