Near patient testing for glycated haemoglobin
| ISRCTN | ISRCTN65773146 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65773146 |
| Protocol serial number | RBG 99X24 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Trent (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 28/02/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of General Practice and Primary Health Care
Leicester
LE5 4PW
United Kingdom
LE5 4PW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
