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临床试验/NCT04506216
NCT04506216已完成不适用

Prevalence of Eating Disorders in Adult Patients With Type I Diabetes and Insulin Pump Treatment

Icadom2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Icadom
入组人数
200
试验地点
2
主要终点
Eating disorders in men and women

研究概览

简要总结

The purpose of this study is to determine the prevalence of eating disorders in type 1 insulin-dependent diabetes patients

详细描述

The risk of developing an eating disorder is increased in type 1 diabetes patients and associated with a poor prognosis in terms of glycemic control, metabolic complications, degenerative complications, and mortality.

Therefore the terminology diaboulimia has emerged to characterize an eating disorder specific to type 1 insulin-dependent diabetes patients, with insulin under dosage with a view of losing or controlling weight and that can contribute to a deterioration of the body composition.

The purpose of this study is to determine the prevalence of eating disorders in an adult cohort with type 1 insulin-dependent diabetes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient over 18 years of age with type 1 diabetes treated with a subcutaneous insulin pump
  • Patient followed up for a subcutaneous insulin pump treatment by the healthcare provider, participating in the study (Agir à Dom group).
  • Beneficiary of social security coverage.

排除标准

  • Patient with type 2 diabetes or MODY diabetes
  • Patient wearing a pacemaker
  • Breastfeeding or pregnant woman
  • Deprived of liberty by judicial or administrative decision
  • Legal guardianship

结局指标

主要结局

Eating disorders in men and women

时间窗: at inclusion

To determine eating disorder prevalence in differentiated adult men and women with type 1 insulin-dependent diabetes. Patients answer to the SCOFF-F questions : * do you make yourself sick because you feel uncomfortably full? * do you worry that you have lost control over how much you eat? * have you recently lost more than one stone in a 3 month period? * do you believe yourself to be fat when others say you are too thin? * would you say that food dominates your life? Every "yes" attributes one point and gives a final score between 0 and 5; a score ≥2 indicates an eating disorder.

次要结局

  • Overall glycemia(at inclusion)
  • Glycemic variability(at inclusion)
  • Basal/Bolus insulin ratio(at inclusion)
  • Adherence to the sensor(at inclusion)
  • Boluses performed per day(at inclusion)
  • Body composition(at inclusion)
  • Blood glucose monitoring(at inclusion)
  • Eating disorders in cohort(at inclusion)
  • Continuous glycemic control(at inclusion)
  • Auto declared insulin under dosage(at inclusion)

研究者

发起方
Icadom
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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