Cystic Fibrosis Related Diabetes Screening.

Study Overview
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Brief Summary
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Cystic fibrosis-related diabetes is a late cystic fibrosis (CF) associated comorbidity whose prevalence is increasing sharply lifelong. Guidelines for glucose metabolism (GM) monitoring relies on oral glucose tolerance test . However, this test is neither sensitive nor specific. The aim of this study is to compare sensitivity and specificity of different methods for GM monitoring in children and adolescents with CF. Continuous GM system (CGMS) will be used as the reference method. Results will be compared to those of oral glucose tolerance test (OGTT), intravenous glucose tolerance test (IGTT), homeostasis model assessment index of insulin resistance (HOMA-%IR) , homeostasis model assessment index of beta-cell function (HOMA-%B) and HbA1C dosage (glycated haemoglobin A1C). Patients will be classified into three groups according to CGMS: normal glucose tolerance, impaired glucose tolerance and diabetes mellitus.

Official Title
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Sensitivity and Specificity of Different Methods for Cystic Fibrosis-related Diabetes Screening.

Conditions
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Cystic Fibrosis-related Diabetes

Intervention / Treatment
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* Other: glucose solution at a dose of 1.75 g/kg (up to a maximum of 75 g) for the OGTT and glucose solution at a dose of 0.5 g/kg (up to a maximum of 35 g) was injected in 2.5-3 min for the IGTT
* Procedure: HGPIV diagnosis test
* Procedure: HOMAR-IR diagnosis test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with confirmed diagnosis of Cystic Fibrosis with a sweat chloride > 60 mmol/L. Subjects will be aged between 10 and 18 years with at least one class 1 or 2 Cystic fibrosis transmembrane conductance regulator (CFTR) mutation. Subjects will be pancreatic insufficient. Subjects must have a forced expiratory volume 1 (FEV1)> 40 % of predicted normal for age, sex and height at the screening visit. Stable CF disease as judged by the investigator Exclusion Criteria: Subjects with glucose intolerance abnormalities Subjects with pulmonary exacerbation within 4 weeks before screening History of lung or hepatic transplantation or awaiting transplantation

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Continuous glucose monitoring system<br>OGTT followed by continuous glucose monitoring system and finally IGTT and HbA1C dosage | Other: glucose solution at a dose of 1.75 g/kg (up to a maximum of 75 g) for the OGTT and glucose solution at a dose of 0.5 g/kg (up to a maximum of 35 g) was injected in 2.5-3 min for the IGTT<br>* At the first visit at day 1an OGTT will be performed then the CGMS is implanted. Capillary glycaemia will be taken four times a day to set up the CGMS. A second visit is scheduled at day 4, where the intravenous glucose tolerance test is performed as well as the HbA1C level.<br>Procedure: HGPIV diagnosis test<br> <br> Procedure: HOMAR-IR diagnosis test<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the sensitivity and the specificity of IGTT (intravenous glucose tolerance test) for the diagnosis of diabetes mellitus in comparison to a continuous glucose monitoring system |  | Day 3 | 
| Measurement of the sensitivity and the specificity of HOMA-%IR (homeostasis model assessment index of insulin resistance) for the diagnosis of diabetes mellitus in comparison to a continuous glucose monitoring system. |  | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the prevalence of diabetes mellitus. |  | Day 3 | 
| Correlation between IGTT and HOMA-%IR data and HbA1C dosage (glycated haemoglobin A1C). |  | Day 3 | 
| Measurement of glucose intolerance |  | Day 3 | 
| Correlation between IGTT and HbA1C dosage (glycated haemoglobin A1C). |  | Day 3 |