Cystic Fibrosis Clinical Trial
— AtHomeOfficial title:
Simplification of CF-related Diabetes Screening by the Use of a Home-based Oral Glucose Tolerance Test (OGTT): A Pilot Study to Evaluate the Validity and Patients' Perceptions
NCT number | NCT03227094 |
Other study ID # | AtHome |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 13, 2017 |
Est. completion date | April 1, 2020 |
Verified date | June 2020 |
Source | Institut de Recherches Cliniques de Montreal |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cystic fibrosis (CF)-related diabetes (CFRD) is the most common complication after pulmonary
complications. This specific form of diabetes is associated with an increased morbidity and
mortality. CFRD prevalence at the age of 10 is 10% and reaches 40 to 50% in adulthood, while
another 35% of adult patients presents impaired glucose tolerance.
In order to identify patients at risk and to implement early therapeutic measures, an annual
CFRD screening test should therefore be undertaken for CF patients after 10 years of age. The
2-hour oral glucose tolerance test (OGTT) with a sweet beverage is the recommended screening
test. However, participation rates for screening tests are far from optimal. For examples, in
2015, the investigators observed that only 47% of non-diabetic patients attended to planned
screening despite large availability and advertisement (unpublished data). Comparable low
levels of screening for CFRD, usually below 33%, have been reported by various teams. Several
reasons could explain these low adherence rates. Some factors are related to patients
perceptions and experience: OGTT is perceived as an additional medical burden requiring a
scheduled appointment (several weeks after the last exacerbation); overnight fasting followed
by the intake of a large glucose load within 5 minutes can lead to nausea, headache, bloating
and fatigue; some patients fear multiple blood sampling, etc. In addition, in case of CFRD
diagnosis, recommended capillary blood glucose monitoring, nutritional advice and treatment
(insulin) are perceived as extremely invasive and complex, thus some patients prefer avoiding
screening test. To date, no alternative screening method has demonstrated its effectiveness
to screen for CFRD. The investigators of this study believe that a simplified version of the
OGTT would be more attractive, would make it more acceptable for patients and has the
potential to improve their adherence to screening tests, simplify CF-team works and reduce
costs. By allowing appropriate education and introduction of treatment in a timely manner,
improved adherence to annual screening for dysglycemia has the potential to minimize or
prevent clinical deterioration observed in years preceding CFRD onset.
Status | Completed |
Enrollment | 37 |
Est. completion date | April 1, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult CF-patient without known diabetes - In stable condition at least 1-month apart from the last exacerbation. Exclusion Criteria: - Known CFRD - Recent exacerbation - Use medications known to interfere with glucose metabolism such as oral steroids. |
Country | Name | City | State |
---|---|---|---|
Canada | CHUM | Montreal | Quebec |
Canada | Montreal Clinical Research Institute (IRCM) | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Institut de Recherches Cliniques de Montreal | Université de Montréal, Vertex Pharmaceuticals Incorporated |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Internal validity | Specificity and sensitivity of both home-based OGTTs versus a standard OGTT in controlled setting | OGTTs performed within 14 days | |
Primary | Predictive value (positive and negative) | Both home-based OGTTs versus a standard OGTT in controlled setting | OGTTs performed within 14 days | |
Secondary | Patient's perception | Visual analog scale questionnaire | OGTTs performed within 14 days | |
Secondary | Cost evaluation of methods | Estimated cost of each methods | OGTTs performed within 14 days |
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