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

NCT ID: NCT02703155

Last Updated: 2016-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-10-31

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.

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.

Conditions

Cystic Fibrosis Related Diabetes; Cystic Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Home Oral Glucose Tolerance Test kit

Intervention Type: DEVICE

Providing Home Oral glucose tolerance test kit to children with Cystic fibrosis for screening Cystic Fibrosis Related Diabetes

Interventions

Home Oral Glucose Tolerance Test kit

Providing Home Oral glucose tolerance test kit to children with Cystic fibrosis for screening Cystic Fibrosis Related Diabetes

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: collaborator

Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Peters, FRCPCH, MD.

Role: PRINCIPAL_INVESTIGATOR

Great Ormond Street Hospital

Locations

Great Ormond Street Hospital

London, London, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Catherine Peters, FRCPCH, MD.

Role: CONTACT

catherine.peters@gosh.nhs.uk

02078138247

References

Bethel MA, Price HC, Sourij H, White S, Coleman RL, Ring A, Kennedy IE, Tucker L, Holman RR. Evaluation of a self-administered oral glucose tolerance test. Diabetes Care. 2013 Jun;36(6):1483-8. doi: 10.2337/dc12-0643. Epub 2013 Jan 15.

Reference Type: BACKGROUND

PMID: 23321216 (View on PubMed)

Moran A, Brunzell C, Cohen RC, Katz M, Marshall BC, Onady G, Robinson KA, Sabadosa KA, Stecenko A, Slovis B; CFRD Guidelines Committee. Clinical care guidelines for cystic fibrosis-related diabetes: a position statement of the American Diabetes Association and a clinical practice guideline of the Cystic Fibrosis Foundation, endorsed by the Pediatric Endocrine Society. Diabetes Care. 2010 Dec;33(12):2697-708. doi: 10.2337/dc10-1768. No abstract available.

Reference Type: BACKGROUND

PMID: 21115772 (View on PubMed)

Wickens-Mitchell KL, Gilchrist FJ, McKenna D, Raffeeq P, Lenney W. The screening and diagnosis of cystic fibrosis-related diabetes in the United Kingdom. J Cyst Fibros. 2014 Sep;13(5):589-92. doi: 10.1016/j.jcf.2014.01.008. Epub 2014 Feb 14.

Reference Type: BACKGROUND

PMID: 24529737 (View on PubMed)

Management of cystic fibrosis related diabetes mellitus. Report of the UK Cystic Fibrosis Trust Diabetes Working Group; 2004 [June, n.d.].

Reference Type: BACKGROUND

Ode KL, Moran A. New insights into cystic fibrosis-related diabetes in children. Lancet Diabetes Endocrinol. 2013 Sep;1(1):52-8. doi: 10.1016/S2213-8587(13)70015-9. Epub 2013 May 23.

Reference Type: BACKGROUND

PMID: 24622267 (View on PubMed)

Kern AS, Prestridge AL. Improving screening for cystic fibrosis-related diabetes at a pediatric cystic fibrosis program. Pediatrics. 2013 Aug;132(2):e512-8. doi: 10.1542/peds.2012-4029. Epub 2013 Jul 1.

Reference Type: BACKGROUND

PMID: 23821699 (View on PubMed)

Related Links

http://www.diabetes.co.uk/oral-glucose-tolerance-test.html

www.diabetes.co.uk

Other Identifiers

14HM13

Identifier Type: -

Identifier Source: org_study_id