Comparing Two Different Approaches in the Screening of Cystic Fibrosis Related Diabetes (CFRD)

This study has been completed.
Sponsor:
Collaborator:
Royal Brompton & Harefield Foundation Trust
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01091025
First received: March 18, 2010
Last updated: March 19, 2010
Last verified: March 2010
  Purpose

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.

Condition Intervention
Screening of Cystic Fibrosis Related Diabetes.
Other: Glucose profile for 2 weeks

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    1. Patients identified for OGTT based on the selective approach by the two independent reviewers will be compared.
    2. Patients will form two groups:

      i)those identified as needing OGTT, ii)those on whom they considered it unnecessary

    3. The results of the two groups will then be compared with the data obtain from OGTT to which the two reviewers were 'blinded'


Secondary Outcome Measures:
  • Which is the more cost effective way of screening all patients with OGTT? [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    1. Calculate the cost of glucose powder and laboratory analysis for each OGTT.
    2. 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.


Enrollment: 100
Study Start Date: March 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091025

Locations
United Kingdom
Royal Brompton & Harefield Foundation Trust
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Imperial College London
Royal Brompton & Harefield Foundation Trust
Investigators
Principal Investigator: Maragret E Hodson, Professor Imperial College London, United Kingdom
  More Information

No publications provided

Responsible Party: Professor Margaret Hodson, Consultant Physician, Respiratory Medicine, Imperial College/ Royal Brompton & Harefield Foundation Trust
ClinicalTrials.gov Identifier: NCT01091025     History of Changes
Other Study ID Numbers: CRO-1210
Study First Received: March 18, 2010
Last Updated: March 19, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Adults
Cystic Fibrosis Related Diabetes
Screening
Oral glucose tolerance test
Royal Brompton & Harefield Foundation Trust

Additional relevant MeSH terms:
Cystic Fibrosis
Diabetes Mellitus
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014