Screening of Cystic Fibrosis Related DiabetesCFRDNCT01091025
Comparing Two Different Approaches in the Screening of Cystic Fibrosis Related Diabetes
A study testing Glucose profile for 2 weeks in people with Screening of Cystic Fibrosis Related Diabetes, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Screening of Cystic Fibrosis Related Diabetes
- What is being tested?
- Glucose profile for 2 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2009to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- patients with an existing diagnosis of CFRD.
- patients with an infective exacerbation (i.e. on a new course of antibiotics)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton & Harefield NHS Foundation Trust
London, SW3 6NP
About this study
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
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.
Read the 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.
- Being tested
- Glucose profile for 2 weeks
- Keywords
- Adults, Cystic Fibrosis Related Diabetes, Screening, Oral glucose tolerance test, Royal Brompton & Harefield Foundation Trust
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose profile for 2 weeksOther
A study subject has an abnormal OGTT will be referred to a cystic fibrosis consultant who is not involved in the study.
| Study group | Role | What they receive |
|---|---|---|
| CF patients without known diagnose of CFRD | Other | 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. Receives: Other: Glucose profile for 2 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startMar 2009
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Screening of Cystic Fibrosis Related DiabetesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Maragret E Hodson, Professor, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091025
- Sponsor's protocol ID
- CRO-1210
- Acronym
- CFRD
- Status last verified
- Mar 2010
- First submitted
- 18 Mar 2010
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01091025
- Acronym / sponsor ID
- CFRD / CRO-1210
- Keywords
- Adults, Cystic Fibrosis Related Diabetes, Screening, Oral glucose tolerance test, Royal Brompton & Harefield Foundation Trust
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 23 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CF patients without known diagnose of CFRD | Other | Other: Glucose profile for 2 weeksThere 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- patients with an existing diagnosis of CFRD.
- patients with an infective exacerbation (i.e. on a new course of antibiotics)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose profile for 2 weeksA study subject has an abnormal OGTT will be referred to a cystic fibrosis consultant who is not involved in the study. | Other | CF patients without known diagnose of CFRD |
Primary outcome
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
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'
1 secondary outcome
Which is the more cost effective way of screening all patients with OGTT?
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maragret E Hodson, Professor principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose profile for 2 weeks in people with Screening of Cystic Fibrosis Related Diabetes, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.