Cystic Fibrosis Clinical Trial
Official 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
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screening despite large availability and advertisement (unpublished data).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.
The investigators propose a pilot study to evaluate the validity and the acceptability of a
home-based OGTT by comparing, in patients with CF:
- Standard hospital-based OGTT with measures of plasma glucose and the use of 75g glucose
beverage;
- Home-based OGTT with measures of glucose using a continuous glucose monitoring system
(CGMS; without blood sample collection) and the 75g glucose beverage;
- Home-based OGTT with measures of glucose using CGMS and 75g of glucose from candies as a
substitute to this poorly appreciate beverage.
Specific objectives are to determine i) the internal validity (specificity, sensitivity) of
both home-based OGTTs versus a standard OGTT in controlled setting, and ii) the predictive
value (positive and negative). The investigators will also iii) investigate patient's
perception and likelihood that the proposed method improves adherence to annual screening,
and iv) evaluate potential cost reduction associated with proposed simplified screening
tests.
On the day of the OGTT, and after obtaining informed consent, a CGMS will be installed.
Patients will receive the very simple training required to use it as well as a pre-packed
Jelly Beans bag containing 75g of glucose and a standard 75g glucose beverage bottle. This
CGMS will provide interstitial glucose values each 15 min over the next 14 days.
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