Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
03/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kamlesh Khunti

ORCID ID

Contact details

Department of General Practice and Primary Health Care
University of Leicester
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 (0) 116 258 4873

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes