Comparing Two Different Approaches in the Screening of Cystic Fibrosis Related Diabetes (CFRD)
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|ClinicalTrials.gov Identifier: NCT01091025|
Recruitment Status : Completed
First Posted : March 23, 2010
Last Update Posted : December 22, 2017
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
- 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.
- To compare the cost effectiveness of the two approaches in the screening for CFRD.
|Condition or disease||Intervention/treatment||Phase|
|Screening of Cystic Fibrosis Related Diabetes||Other: Glucose profile for 2 weeks||Not Applicable|
CFRD affects 30% of all patients with cystic fibrosis (CF) by the age of twenty−five. Early diagnosis of CFRD is crucial to prevent the unnecessary deterioration of pulmonary function and nutritional status, both of which affect the patient's overall survival. The selective approach takes less patient time and is less expensive. If it is equally accurate it should be used routinely. The oral glucose tolerance test (OGTT) is the accepted method for detecting CFRD and the Cystic Fibrosis Trust guidelines recommend that patients with CF over the age of twelve years should be screened annually. Yung et al, questioned this approach and argued that 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 this study, a selective approach in performing OGTTs in the screening for CFRD will be used; this includes the use of a combination of clinical and biochemical criteria that of abnormal random blood glucose and /or abnormal glycosylated haemoglobin (HbA1c) and/or symptoms of hyperglycaemia, or weight loss.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||January 2010|
CF patients without known diagnose of CFRD
There is only one arm. All patients in the study had the same procedures (ie. an OGTT). Investigators used the screening criteria in parallel to this.
Other: Glucose profile for 2 weeks
A study subject has an abnormal OGTT will be referred to a cystic fibrosis consultant who is not involved in the study.
- To identify if using the selective approach to screen for CFRD is as accurate as screening all patients with OGTT at annual review. [ Time Frame: 6 months ]
- 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'
- Which is the more cost effective way of screening all patients with OGTT? [ Time Frame: 6 months ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01091025
|Royal Brompton & Harefield NHS Foundation Trust|
|London, United Kingdom, SW3 6NP|
|Principal Investigator:||Maragret E Hodson, Professor||Imperial College London|