DIATRIM : Effect of One Year Elexacaftor-tezacaftor-ivacaftor Treatment on Glucose Tolerance Abnormalities in Adult Patients With Cystic Fibrosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Evaluate time in range of blood glucose variation >140 mg/dl during 2 weeks in a cohort of adult patients treated for one year with elexacaftor-tezacaftor-ivacaftor
研究概览
简要总结
The development of CFTR (cystic fibrosis conductance transmembrane regulator) modulators for people with cystic fibrosis (pwCF) and eligible for these treatments is a true therapeutic revolution. The major beneficial effect of CFTR modulators (CFTRm) on pulmonary function and the reduction of pulmonary exacerbations should have a considerable impact on the quality of life and patient's life expectancy. Data on the impact of CFTRm on glucose tolerance abnormalities are still very fragmentary. The investigators can think that their use, earlier and earlier in the history of the disease, will transform the evolutionary trajectories of patients on the respiratory, nutritional and metabolic levels.
Diabetes represents a major challenge in the management of pwCF because it is a factor in morbidity and mortality at all stages of the disease, from children to patients with terminal respiratory failure requiring lung transplantation. Early abnormalities in glucose tolerance observed in childhood, before the stage of diabetes, are also associated with poor pulmonary and nutritional outcomes. Experimental data suggest a positive effect of CFTRm on insulin secretion. However, investigators do not currently know the impact of CFTRm in patients with very early glucose disorders or at the stage of diabetes treated with insulin. Recently continuous glucose measurement (CGM) devices represent very effective tools for assessing abnormalities in glucose tolerance before the stage of diabetes and for monitoring patients treated with insulin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cystic fibrosis aged over 18
- •Patients treated for 1 year by elexacaftortezacaftor-ivacaftor
- •Normal tolerant or intolerant to glucose or presenting with cystic fibrosis related diabetes treated or not with insulin
- •Patient who had a continuous glucose monitoring in the 6 months before and 6 months after one year of treatment with elexacaftor-tezacaftor-ivacaftor
排除标准
- •Patient not eligible for triple CFTR modulator
- •Patient intolerant to triple corrector
- •Pregnant woman
研究组 & 干预措施
Adult patients with cystic fibrosis
干预措施: elexacaftor-tezacaftor-ivacaftor treatment (Drug)
结局指标
主要结局
Evaluate time in range of blood glucose variation >140 mg/dl during 2 weeks in a cohort of adult patients treated for one year with elexacaftor-tezacaftor-ivacaftor
时间窗: time in range of blood glucose variation >140 mg/dl one year before and one year after the begining of elexacaftor-tezacaftor-ivacaftor treatment
次要结局
- Assessment of respiratory function parameters : number of IV antibiotics(One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment)
- Evaluate other CGM parameters : time in range of blood glucose >180mg/dl ; >140mg/dl ; <70mg/dl ; 70-180 mg/dl ; 70-140mg/dl(One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment)
- Marker of metabolic status: C-Peptid (µg/L)(One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment)
- Marker of metabolic status: C-Peptid (nmol/L)(One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment)
- Markers of nutritional status: Evaluation of weight monitoring (kg)(One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment)
- Marker of metabolic status: HbA1c (mmol/l)(One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment)
- Marker of metabolic status: HbA1c (%)(One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment)
- Markers of nutritional status: Body Mass Index (BMI)(One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment)
- Diabetes treatment (assess insulin needs) : mean glucose value per day (mg/dl)(One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment)
- Number patients with severe hypoglycaemia and serious adverse events(One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment)