Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RBG 99X24
Study information
Scientific title
Acronym
Study hypothesis
A randomised controlled trial of near patient testing for glycated haemoglobin in people with diabetes mellitus in primary care.
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
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
Phase
Not Specified
Drug names
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 trial start date
01/03/2000
Overall trial end date
28/02/2002
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
780
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/2000
Recruitment end date
28/02/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of General Practice and Primary Health Care
Leicester
LE5 4PW
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Trent (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
Basic results (scientific)
Publication list
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16834877
2. 2007 acceptability and satisfaction results in http://www.ncbi.nlm.nih.gov/pubmed/17451419
Publication citations
-
Results
Khunti K, Stone MA, Burden AC, Turner D, Raymond NT, Burden M, Baker R, Randomised controlled trial of near-patient testing for glycated haemoglobin in people with type 2 diabetes mellitus., Br J Gen Pract, 2006, 56, 528, 511-517.
-
Acceptability and satisfaction results
Stone MA, Burden AC, Burden M, Baker R, Khunti K, Near patient testing for glycated haemoglobin in people with Type 2 diabetes mellitus managed in primary care: acceptability and satisfaction., Diabet. Med., 2007, 24, 7, 792-795, doi: 10.1111/j.1464-5491.2007.02175.x.