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The Use of Home Oral Glucose Tolerance Test Kit in Screening Cystic Fibrosis Related Diabetes (HomeOGTT)

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ClinicalTrials.gov Identifier: NCT02703155
Recruitment Status : Unknown
Verified March 2016 by Great Ormond Street Hospital for Children NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

Brief Summary:
The aim of this study is to establish if the self-administered electronic Oral Glucose Tolerance Test kit can increase the annual uptake of screening for CFRD in children who are between 10 and 17 years of age with CF.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Related Diabetes Cystic Fibrosis Device: Home Oral Glucose Tolerance Test kit Not Applicable

Detailed Description:

Cystic fibrosis related diabetes (CFRD) is the most common secondary complication of Cystic fibrosis. It affects nearly 20% of adolescents and 40-50% of adults. Undiagnosed CFRD is associated with significant decline in lung function and nutritional status with an increase in mortality. This emphasises the importance of screening for CFRD in children with CF to minimise the nutritional and pulmonary consequences of diabetes.

The UK CF trust guidelines, the European consensus statement and US Cystic Fibrosis Foundation clinical care guidelines recommend the 2hr (1.75g/kg) oral glucose tolerance test as a screening tool on an annual basis in all CF patients without CFRD.

The American Diabetes Association (A.D.A) recommends that annual screening for CFRD should begin by age 10 years in all CF patients who do not have CFRD. The European Consensus Statement on this is in agreement for screening to start at age 10 years. This standard is often applied within the United Kingdom.

The current gold standard screening tool, the Oral Glucose Tolerance Test, is resource intensive. This requires an individual/child and a parent to attend a clinical facility while fasted and requires trained health care professionals to take venous samples, analyse and interpret the results.

There are also problems encountered in standardising the test. The patient should be fasted and must travel to clinic for the test in the morning. The OGTT, if done at hospital, can therefore affect an individual's time off work, time off school, can cause inconvenience and expensive for an individual, parent and child to travel to clinic. The unpredictability of workload for hospital staff means that test times are often not strictly adhered to or accurately recorded. In patients with cystic fibrosis there is also an additional risk of cross infection when they attend the hospital for OGTT. These factors limit the uptake of OGTTs for screening in children with cystic fibrosis.

To overcome these issues a simple, disposable, self-administered electronic OGTT Kit containing everything required to perform the OGTT at home with simple written and pictorial instructions has been used in this study.

The aim of this study is to establish if the self-administered electronic Oral Glucose Tolerance Test kit can increase the annual uptake of screening for CFRD in children who are between 10 and 17 years of age with CF.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Use of Self-Administered Electronic Oral Glucose Tolerance Test Kit in Screening Cystic Fibrosis Related Diabetes in Children With Cystic Fibrosis
Study Start Date : October 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Dextrose

Arm Intervention/treatment
Home Oral Glucose tolerance test kit
Providing children with Cystic Fibrosis between 10 and 17 years of age with Home Oral glucose tolerance test kit to screen Cystic fibrosis related Diabetes.
Device: Home Oral Glucose Tolerance Test kit
Providing Home Oral glucose tolerance test kit to children with Cystic fibrosis for screening Cystic Fibrosis Related Diabetes




Primary Outcome Measures :
  1. proportion of annual screening for Cystic Fibrosis Related Diabetes(CFRD) in children between 10years and 17 years with Cystic Fibrosis(CF) using the Home OGTT device. [ Time Frame: 1 year ]
    Proportion of annual screening for Cystic Fibrosis Related Diabetes(CFRD) in children between 10years and 17 years with Cystic Fibrosis(CF).


Secondary Outcome Measures :
  1. User acceptability -Questionnaire [ Time Frame: 1 year ]
    To assess the user acceptability of Home OGTT device.

  2. Variability- timing of sample [ Time Frame: 1 year ]
    To assess if Home OGTT device can reduce the variability of times when the test was done i-e at 0 hrs and 2 hrs later following a glucose drink.



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children diagnosed with cystic fibrosis who are between 10 years and 17years old and managed at Great Ormond Street Hospital.

Exclusion Criteria:

  • Children who are diagnosed with cystic fibrosis related diabetes.

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): NCT02703155


Contacts
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Contact: Catherine Peters, FRCPCH, MD. 02078138247 catherine.peters@gosh.nhs.uk

Locations
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United Kingdom
Great Ormond Street Hospital Recruiting
London, United Kingdom
Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
University College, London
Investigators
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Principal Investigator: Catherine Peters, FRCPCH, MD. Great ormond Street Hospital

Additional Information:
Publications:
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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02703155     History of Changes
Other Study ID Numbers: 14HM13
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases