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临床试验/NCT04819178
NCT04819178撤回不适用

Real Life Evaluation of SGLT2 Use in Type 1 Diabetes

Steno Diabetes Center Copenhagen3 个研究点 分布在 1 个国家开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
3
主要终点
Diabetic ketoacidosis

研究概览

简要总结

The primary aim of the study is to prospectively monitor the risk of diabetic ketoacidosis (DKA) during treatment with sodium-glucose cotransporter 2 (SGLT2) inhibitors in type 1 diabetes after the treatment has become available as an adjunct therapy for people with type 1 diabetes.

详细描述

SGLT2 inhibitors have recently been approved for treatment of type 1 diabetes. SGLT2 inhibitors affect renal glucose transport and promotes glucose excretion in the urine. This have attractive effects, notably by lowering of blood glucose without any increased risk of hypoglycemia as well as a reduction in body weight. Since the risk of hypoglycemia and weight gain during intensification of insulin treatment is a significant barrier for optimal glycemic control, SGLT2 inhibitors could be an attractive adjunct therapy in type 1 diabetes. Furthermore, SGLT2 inhibitors have beneficial cardiovascular and renal effects in persons with type 2 diabetes. This may also benefit persons with type 1 diabetes. However, the major limitation for an universal use of SGLT2 inhibitors in type 1 diabetes is a substantial increase in ketogenesis and the risk of DKA. DKA remain a substantial cause of morbidity and mortality in persons with type 1 diabetes.

Since no data exist on the risk of DKA during SGLT2 inhibition outside the randomized controlled trials, the investigators will initiate a nationwide monitoring study on the use of SGLT2 inhibitors in type 1 diabetes. This will ensure follow-up on the efficacy, safety and patient-reported outcome measures for SGLT2 inhibitors treatment of type 1 diabetes in real-world clinical practice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patiens with type 1 diabetes on SGLT2 inhibitor treatment or where this treatment is planned.

排除标准

  • 未提供

结局指标

主要结局

Diabetic ketoacidosis

时间窗: 3 years

Registration of incidents of DKA will be done based on data from medical records, as well as reporting from patients and registries.

次要结局

  • Side effects(3 years)
  • Efficacy of treatment(3 years)
  • Patient reported outcome(3 years)
  • Hypoglyceamia(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Rossing

Professor, DM, Peter Rossing

Steno Diabetes Center Copenhagen

研究点 (3)

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