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临床试验/NCT04162067
NCT04162067已完成不适用

Type 1 Diabetes in Canada: The Demographic, Care Profiles and Glycemic Control of Patients Living With Type 1 Diabetes From the LMC Diabetes Patient Registry

LMC Diabetes & Endocrinology Ltd.1 个研究点 分布在 1 个国家目标入组 3,600 人开始时间: 2020年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,600
试验地点
1
主要终点
HbA1c

研究概览

简要总结

This retrospective study uses the Canadian LMC Diabetes Registry to describe the current health status of Canadians with type 1 diabetes. The study provides a detailed report of the demographic composition, treatment regimens, self-care approaches, health status, metabolic outcomes, and glycemic control of a large Canadian community-based, specialist-led cohort of patients with type 1 diabetes. Specific study outcomes will also be evaluated in a subgroup of patients using continuous subcutaneous insulin infusion (CSII) therapy.

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

入选标准

  • Clinical diagnosis of type 1 diabetes for ≥ 6 months
  • Assessed by an LMC endocrinologist between July 1, 2015 and June 30, 2018
  • Followed by an LMC endocrinologist for > 6 months
  • Informed consent provided and signed for medical record data to be used for research purposes

排除标准

  • clinical diagnosis of type 2 diabetes

结局指标

主要结局

HbA1c

时间窗: 1 day

HbA1c will be measured by accessing patients medical records and it will be evaluated at one time point only. The value will be the last measured value for each patient between January 2015 and June 2019

次要结局

  • Fasting plasma glucose(1 day)
  • Weekly incidence of any hypoglycemia(1 day)
  • Yearly incidence of severe hypoglycemia(1 day)
  • Insulin therapy regimen(1 day)
  • Adjunct diabetes therapies(1 day)
  • Lipid lowering therapies(1 day)
  • Glucose meter use(1 day)
  • Glucagon availability(1 day)
  • Clinical outcomes stratified by age group(1 day)
  • Proportion of patients with HbA1c ≤7.0%, 7.1 to 8.0%, 8.1 to 9.0% and >9.0%(1 day)
  • Proportion of patients below and above target LDL cholesterol(1 day)
  • Blood pressure(1 day)
  • Thyroid stimulating hormone (TSH)(1 day)
  • Microvascular comorbidity(1 day)
  • Albuminuria(1 day)
  • Macrovascular comorbidity(1 day)
  • Insulin type(1 day)
  • Lipid parameters(1 day)
  • estimated glomerular filtration rate (eGFR)(1 day)
  • Weight(1 day)
  • Body mass index (BMI)(1 day)
  • Alanine aminotransferase (ALT)(1 day)
  • Pump model(1 day)
  • Antihypertensive therapies(1 day)
  • Mental health therapies(1 day)
  • Continuous glucose monitor (CGM) use(1 day)
  • Waist circumference(1 day)
  • Mental health comorbidity(1 day)
  • Erectile dysfunction(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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