Cystic FibrosisCFRDNCT01883037
Comparing Laboratory Blood Glucose Results With HemoCue Glucose 201 RT
An observational study of Cystic Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
There are very few studies comparing the accuracy, sensitivity and specificity of HemoCue glucose 201 RT system with the laboratory gold standard. The incidence of cystic fibrosis related diabetes (CFRD) has risen significantly as patients' survival improves. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Blood glucose results
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to May 2014
- Phase
- Observational
- 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
Study population: The first 70 consecutive adult CF patients, without cystic fibrosis related diabetes, who are 16 years of age and over, attending annual review at the Royal Brompton Hospital from June 2013, are eligible for the study.
Who may be able to join
- The first 70 consecutive suitable consenting adult CF patients, who are 16 years of age and over, attending annual review at the Royal Brompton Hospital from June 2013 to March 2014, are eligible for the study
Who cannot join
- Patients with an existing diagnosis of CFRD are exclude.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare the Clinical Accuracy of Glucose Measurement During Oral Glucose Tolerance Test Using Two Methods: i) Laboratory Standard Technique, ii) HemoCue Glucose 201 RT System
There are very few studies comparing the accuracy, sensitivity and specificity of HemoCue glucose 201 RT system with the laboratory gold standard.
The incidence of cystic fibrosis related diabetes (CFRD) has risen significantly as patients' survival improves. Around 30% of all cystic fibrosis (CF) adult patients have CFRD. Early diagnosis of CFRD is important to slow the deterioration of lung function and nutritional status, both of which increase mortality.
Read more
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.
The World Health Organisation has pointed out that due to the absence of a more specific biological marker to define diabetes, plasma glucose estimation remains the basis of diagnostic criteria. WHO recommends that venous plasma glucose should be the standard method for measuring and reporting glucose concentration in blood. However, it has also recognised that there is a widespread use of capillary sampling. Although fasting values for venous and capillary plasma glucose are the same, in the nonfasting state capillary samples will give higher results than venous samples, and glucose values require conversion which can be problematic.
HemoCue Glucose 201 RT (HGS 201 RT) analyzer with plasma conversion provides laboratory quality test results at the point of care for the diagnosis, screening and monitoring of diabetes mellitus. The analyzer is easy to use and the system can be operated by nonlaboratory personnel, also the results can be presented immediately, leading to significant time and resource saving. The patient also benefits from having the result immediately instead of waiting for several hours. With immediate result, the doctor and health care professionals can provide education, support and reassurance, and implement care plans, if appropriate, at the earliest opportunity.
The aim of the study is to compare the clinical accuracy of HemoCue Glucose 201 RT with the laboratory standard method in the analysis of blood glucose concentration during oral glucose tolerance test.
Read the detailed description
All CF patients attending annual review who require an OGTT will have a venous and a capillary blood sample taken simultaneously before (fasting = 0 min) and 2 hours (post glucose load = 120 min) after the administration of 75 grams Glucose solution orally.
The capillary sample will be analysed immediately using HGS 201 RT. The venous sample will be collected in a Fluoride Oxalate tube (WHO guideline) and sent to the Trust's laboratory for analysis as per usual practice.
- Conditions
- Cystic Fibrosis
- Being tested
- Blood glucose results
- Keywords
- Cystic Fibrosis, Cystic Fibrosis related diabetes, Oral glucose tolerance test
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood glucose resultsOther
Also called HemoCue Glucose 201 RT
The glucose value from the HemoCue Glucose 201 RT will be compared with the Trust Laboratory value.
| Study group | Role | What they receive |
|---|---|---|
| Laboratory blood glucose | Blood glucose value from Lab Receives: Other: Blood glucose results | |
| HemoCue Glucose 201 RT | Blood glucose value from HemoCue Glucose 201 RT Receives: Other: Blood glucose results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does HemoCue Glucose 201 RT provide lab-quality results in the analysis of glucose values during oral glucose tolerance tests?
The glucose value from the HemoCue Glucose 201 RT will be compared with the Trust Laboratory value. The sensitivity, specificity and clinical significance will be calculated.
Measured: One year
Secondary outcomes (1)
Is HemoCue Glucose 201 RT method cost saving relative to the traditional laboratory method for analysing glucose values taken during oral glucose tolerance tests?
The cost of using the HemoCue Glucose 201 RT will be compared with Trust Laboratory cost for analysing the glucose value from OGTT.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas J Simmonds, MD MRCP, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883037
- Sponsor's protocol ID
- 2012CF007B
- Acronym
- CFRD
- Status last verified
- Nov 2014
- First submitted
- 13 Jun 2013
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Clinical Accuracy of Glucose Measurement During Oral Glucose Tolerance Test Using Two Methods: i) Laboratory Standard Technique, ii) HemoCue Glucose 201 RT System
- ClinicalTrials.gov ID
- NCT01883037
- Acronym / sponsor ID
- CFRD / 2012CF007B
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Cystic Fibrosis related diabetes, Oral glucose tolerance test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Jun 2013 (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.
There are very few studies comparing the accuracy, sensitivity and specificity of HemoCue glucose 201 RT system with the laboratory gold standard.
The incidence of cystic fibrosis related diabetes (CFRD) has risen significantly as patients' survival improves. Around 30% of all cystic fibrosis (CF) adult patients have CFRD. Early diagnosis of CFRD is important to slow the deterioration of lung function and nutritional status, both of which increase mortality.
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.
The World Health Organisation has pointed out that due to the absence of a more specific biological marker to define diabetes, plasma glucose estimation remains the basis of diagnostic criteria. WHO recommends that venous plasma glucose should be the standard method for measuring and reporting glucose concentration in blood. However, it has also recognised that there is a widespread use of capillary sampling. Although fasting values for venous and capillary plasma glucose are the same, in the nonfasting state capillary samples will give higher results than venous samples, and glucose values require conversion which can be problematic.
HemoCue Glucose 201 RT (HGS 201 RT) analyzer with plasma conversion provides laboratory quality test results at the point of care for the diagnosis, screening and monitoring of diabetes mellitus. The analyzer is easy to use and the system can be operated by nonlaboratory personnel, also the results can be presented immediately, leading to significant time and resource saving. The patient also benefits from having the result immediately instead of waiting for several hours. With immediate result, the doctor and health care professionals can provide education, support and reassurance, and implement care plans, if appropriate, at the earliest opportunity.
The aim of the study is to compare the clinical accuracy of HemoCue Glucose 201 RT with the laboratory standard method in the analysis of blood glucose concentration during oral glucose tolerance test.
Detailed description
All CF patients attending annual review who require an OGTT will have a venous and a capillary blood sample taken simultaneously before (fasting = 0 min) and 2 hours (post glucose load = 120 min) after the administration of 75 grams Glucose solution orally.
The capillary sample will be analysed immediately using HGS 201 RT. The venous sample will be collected in a Fluoride Oxalate tube (WHO guideline) and sent to the Trust's laboratory for analysis as per usual practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laboratory blood glucose | – | Other: Blood glucose resultsBlood glucose value from Lab |
| HemoCue Glucose 201 RT | – | Other: Blood glucose resultsBlood glucose value from HemoCue Glucose 201 RT |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The first 70 consecutive adult CF patients, without cystic fibrosis related diabetes, who are 16 years of age and over, attending annual review at the Royal Brompton Hospital from June 2013, are eligible for the study.
Key inclusion criteria (1 listed)
- The first 70 consecutive suitable consenting adult CF patients, who are 16 years of age and over, attending annual review at the Royal Brompton Hospital from June 2013 to March 2014, are eligible for the study
Key exclusion criteria (1 listed)
- Patients with an existing diagnosis of CFRD are exclude.
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 |
|---|---|---|
| Blood glucose resultsAlso: HemoCue Glucose 201 RTThe glucose value from the HemoCue Glucose 201 RT will be compared with the Trust Laboratory value. | Other | HemoCue Glucose 201 RT, Laboratory blood glucose |
Primary outcome
Does HemoCue Glucose 201 RT provide lab-quality results in the analysis of glucose values during oral glucose tolerance tests?
Time frame: One year
The glucose value from the HemoCue Glucose 201 RT will be compared with the Trust Laboratory value. The sensitivity, specificity and clinical significance will be calculated.
1 secondary outcome
Is HemoCue Glucose 201 RT method cost saving relative to the traditional laboratory method for analysing glucose values taken during oral glucose tolerance tests?
Time frame: One year
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 13 Nov 2014.
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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.
Nicholas J Simmonds, MD MRCP principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust 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 1 inclusion and 1 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 13 Nov 2014. 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?
Does HemoCue Glucose 201 RT provide lab-quality results in the analysis of glucose values during oral glucose tolerance tests? (time frame: One year). 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 13 Nov 2014.