Cystic Fibrosis Related DiabetesHomeOGTTNCT02703155
The Use of Home Oral Glucose Tolerance Test Kit in Screening Cystic Fibrosis Related Diabetes
A study testing Home Oral Glucose Tolerance Test kit in people with Cystic Fibrosis Related Diabetes and Cystic Fibrosis, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Cystic Fibrosis Related Diabetes, Cystic Fibrosis
- What is being tested?
- Home Oral Glucose Tolerance Test kit
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Oct 2016
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with cystic fibrosis who are between 10 years and 17years old and managed at Great Ormond Street Hospital.
Who cannot join
- Children who are diagnosed with cystic fibrosis related diabetes.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Great Ormond Street Hospital
London, London
About this study
Official title: The Use of Self-Administered Electronic Oral Glucose Tolerance Test Kit in Screening Cystic Fibrosis Related Diabetes in Children With Cystic Fibrosis
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.
Read the 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
- Being tested
- Home Oral Glucose Tolerance Test kit
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Oral Glucose Tolerance Test kitDevice
Providing Home Oral glucose tolerance test kit to children with Cystic fibrosis for screening Cystic Fibrosis Related Diabetes
| Study group | Role | What they receive |
|---|---|---|
| Home Oral Glucose tolerance test kit | Other | 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. Receives: Device: Home Oral Glucose Tolerance Test kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Proportion of annual screening for Cystic Fibrosis Related Diabetes(CFRD) in children between 10years and 17 years with Cystic Fibrosis(CF).
Measured: 1 year
Secondary outcomes (2)
User acceptability -Questionnaire
To assess the user acceptability of Home OGTT device.
Measured: 1 year
Variability- timing of sample
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis Related DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Sponsor
- Investigators
- Catherine Peters, FRCPCH, MD., Principal investigator, Great Ormond Street Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703155
- Sponsor's protocol ID
- 14HM13
- Acronym
- HomeOGTT
- Status last verified
- Mar 2016
- First submitted
- 9 Feb 2016
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23321216Moran 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.
PubMed 21115772Wickens-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.
PubMed 24529737Management of cystic fibrosis related diabetes mellitus. Report of the UK Cystic Fibrosis Trust Diabetes Working Group; 2004 [June, n.d.].
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.
PubMed 24622267Kern 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.
PubMed 23821699
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Self-Administered Electronic Oral Glucose Tolerance Test Kit in Screening Cystic Fibrosis Related Diabetes in Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02703155
- Acronym / sponsor ID
- HomeOGTT / 14HM13
- Conditions
- Cystic Fibrosis Related Diabetes, Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 9 Mar 2016 (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 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Oral Glucose tolerance test kit | Other | Device: Home Oral Glucose Tolerance Test kitProviding children with Cystic Fibrosis between 10 and 17 years of age with Home Oral glucose tolerance test kit to screen Cystic fibrosis related Diabetes. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children diagnosed with cystic fibrosis who are between 10 years and 17years old and managed at Great Ormond Street Hospital.
Key exclusion criteria (1 listed)
- Children who are diagnosed with cystic fibrosis related diabetes.
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 |
|---|---|---|
| Home Oral Glucose Tolerance Test kitProviding Home Oral glucose tolerance test kit to children with Cystic fibrosis for screening Cystic Fibrosis Related Diabetes | Device | Home Oral Glucose tolerance test kit |
Primary outcome
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).
2 secondary outcomes
User acceptability -Questionnaire
Time frame: 1 year
Variability- timing of sample
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
- Background: PubMed 23321216Bethel 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.
- Background: PubMed 21115772Moran 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.
- Background: PubMed 24529737Wickens-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.
- BackgroundManagement of cystic fibrosis related diabetes mellitus. Report of the UK Cystic Fibrosis Trust Diabetes Working Group; 2004 [June, n.d.].
- Background: PubMed 24622267Ode 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.
- Background: PubMed 23821699Kern 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.
- www.diabetes.co.ukLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Catherine Peters, FRCPCH, MD. principal investigator
Great Ormond Street Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Oral Glucose Tolerance Test kit in people with Cystic Fibrosis Related Diabetes and Cystic Fibrosis, run by Great Ormond Street Hospital for Children 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: status not confirmed, as of the sponsor's last update on 9 Mar 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Peters, FRCPCH, MD. (02078138247, catherine.peters@gosh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02703155, which also lists 6 linked publications.
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 9 Mar 2016.