Near patient testing for glycated haemoglobin
| ISRCTN | ISRCTN65773146 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65773146 |
| Secondary identifying numbers | RBG 99X24 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 03/12/2008
- 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 Kamlesh Khunti
Scientific
Scientific
Department of General Practice and Primary Health Care
University of Leicester
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
| Phone | +44 (0) 116 258 4873 |
|---|
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 objectives | A randomised controlled trial of near patient testing for glycated haemoglobin in people with diabetes mellitus in primary care. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, metabolic and endocrine diseases: Diabetes |
| Intervention | 1. Patients in the intervention arm will have near patient testing (NPT) for their glycated haemoglobin 2. Patients in the control arm will have normal procedure for measurement of glycated haemoglobin |
| Intervention type | Other |
| Primary outcome measure | Main outcome will be the proportion of patients achieving good control. The acceptability and cost effectiveness of the NPT for glycated haemoglobin will be determined. The key measures of success will be an improvement in the number of patients having annual glycated haemoglobin measurements and improvement in glycated haemoglobin levels. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/03/2000 |
| Completion date | 28/02/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 780 |
| Key inclusion criteria | Based on increasing the proportion of patients achieving good control of their HbA by 10%, from around 42%, the currently reported figure with a significance level of 5% and power of 80%, approximately 380-390 patients would be needed in each group, a study sample of 760-780. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2000 |
| Date of final enrolment | 28/02/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of General Practice and Primary Health Care
Leicester
LE5 4PW
United Kingdom
LE5 4PW
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Trent (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 | 01/07/2006 | Yes | No | |
| Results article | acceptability and satisfaction results | 01/07/2007 | Yes | No |
