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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01091025

Acronym

CFRD

Enrollment

100

Registered

2010-03-23

Start date

2009-03-31

Completion date

2010-01-31

Last updated

2017-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Screening of Cystic Fibrosis Related Diabetes

Keywords

Adults, Cystic Fibrosis Related Diabetes, Screening, Oral glucose tolerance test, Royal Brompton & Harefield Foundation Trust

Brief summary

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.

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.

Interventions

OTHERGlucose 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
To identify if using the selective approach to screen for CFRD is as accurate as screening all patients with OGTT at annual review.	6 months	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

Measure	Time frame	Description
Which is the more cost effective way of screening all patients with OGTT?	6 months	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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026