A randomised controlled trial (RCT) to compare minimally invasive glucose monitoring devices to conventional monitoring in the management of insulin treated diabetes mellitus.
| ISRCTN | ISRCTN33678610 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33678610 |
| Secondary identifying numbers | HTA 01/13/03 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 11/06/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Steven Hurel
Scientific
Scientific
Diabetes & Endocrinology
University College London Hospitals Foundation Trust
Mortimer Street
London
W1T 3AA
United Kingdom
| Phone | +44 (0)207 380 9029 |
|---|---|
| s.hurel@ucl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | MITRE |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Not provided at time of registration. |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 01/12/2002 |
| Completion date | 31/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Added as of 10/09/07: Accrual target: 400; Accrual count: 404 |
| Key inclusion criteria | Diabetics |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/12/2002 |
| Date of final enrolment | 31/08/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Diabetes & Endocrinology
London
W1T 3AA
United Kingdom
W1T 3AA
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2009 | Yes | No |
