Screening of Cystic Fibrosis Related Diabetes Clinical Trial
— CFRDOfficial title:
A Comparative Analysis of the Clinical Efficacy of Two Approaches in the Screening for Cystic Fibrosis Related Diabetes in Adult With Cystic Fibrosis: i) a Selective Approach; ii) an Unselected Annual Oral Glucose Tolerance Test
| Verified date | March 2010 |
| Source | Imperial College London |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The incidence of cystic fibrosis related diabetes (CFRD) has risen significantly as patients'
survival improves. Early diagnosis of CFRD is crucial to prevent the unnecessary
deterioration of lung function and nutritional status, both of which affect the patient's
overall survival. The oral glucose tolerance test (OGGT) is the accepted method for detecting
CFRD. The Cystic Fibrosis Trust guidelines (2004) recommend that patients with CF over the
age of twelve years should be screened annually. Most hospitals use an annual OGTT.
Performing OGTT on all CF patients is inconvenient and may not be cost effective, as patients
have to starve overnight and need to spend an extra 2 hours in the hospital in addition to
all the other annual review tests. In our centre, a selective approach is used. If patients
have an abnormal random blood glucose and /or abnormal glycosylated haemoglobin (HbA1c)
and/or symptoms of hyperglycaemia or unexplained weight loss then an OGTT will be performed.
The aims of this study are
1. To compare the clinical efficiency in the screening for CFRD in the two different
methods: i)a selective approach , ii)an unselected annual OGTT for all patients.
2. To compare the cost effectiveness of the two approaches in the screening for CFRD.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | January 2010 |
| Est. primary completion date | December 2009 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility |
Inclusion Criteria: - first one hundred consecutive clinically stable patients with CF attending annual review from January 2009 - 16 years of age and over will be eligible for the study. Exclusion Criteria: - patients with an existing diagnosis of CFRD. - patients with an infective exacerbation (i.e. on a new course of antibiotics) |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Royal Brompton & Harefield NHS Foundation Trust | London |
| Lead Sponsor | Collaborator |
|---|---|
| Imperial College London | Royal Brompton & Harefield NHS Foundation Trust |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To identify if using the selective approach to screen for CFRD is as accurate as screening all patients with OGTT at annual review. | Patients identified for OGTT based on the selective approach by the two independent reviewers will be compared. Patients will form two groups: i)those identified as needing OGTT, ii)those on whom they considered it unnecessary The results of the two groups will then be compared with the data obtain from OGTT to which the two reviewers were 'blinded' |
6 months | |
| Secondary | Which is the more cost effective way of screening all patients with OGTT? | Calculate the cost of glucose powder and laboratory analysis for each OGTT. Compare the cost effectiveness of carrying out OGTT on patients identified by the selective approach with the cost of carrying out OGTT on all patients. |
6 months |