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Comparing Laboratory Blood Glucose Results With HemoCue Glucose 201 RT (CFRD)

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ClinicalTrials.gov Identifier: NCT01883037
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : November 13, 2014
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Brief 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. 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.


Condition or disease Intervention/treatment
Cystic Fibrosis Other: Blood glucose results

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 Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : June 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Group/Cohort Intervention/treatment
Laboratory blood glucose
Blood glucose value from Lab
Other: Blood glucose results
The glucose value from the HemoCue Glucose 201 RT will be compared with the Trust Laboratory value.
Other Name: HemoCue Glucose 201 RT

HemoCue Glucose 201 RT
Blood glucose value from HemoCue Glucose 201 RT
Other: Blood glucose results
The glucose value from the HemoCue Glucose 201 RT will be compared with the Trust Laboratory value.
Other Name: HemoCue Glucose 201 RT




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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? [ Time Frame: One year ]
    The cost of using the HemoCue Glucose 201 RT will be compared with Trust Laboratory cost for analysing the glucose value from OGTT.


Other Outcome Measures:
  1. 2. To see if the HemoCue Glucose 201 RT offers sufficient advantages to make it a viable alternative to conventional testing [ Time Frame: One year ]
    If using HemoCue Glucose 201 RT is shown to offer cost and clinical advantages over conventional testing then look to implement as standard test method and report more widely.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients with an existing diagnosis of CFRD are exclude.


Information from the National Library of Medicine

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): NCT01883037


Locations
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: Nicholas J Simmonds, MD MRCP Royal Brompton & Harefield NHS Foundation Trust

Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01883037     History of Changes
Other Study ID Numbers: 2012CF007B
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Cystic Fibrosis
Cystic Fibrosis related diabetes
Oral glucose tolerance test

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases