临床试验/NCT03489967

NCT03489967已完成不适用

Treatment of Mild-to-moderate Hypoglycemia in Adults With Type 1 Diabetes: a Validation Study

Institut de Recherches Cliniques de Montreal1 个研究点分布在 1 个国家目标入组 29 人开始时间: 2018年4月18日最近更新: 2020年9月17日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 29
试验地点: 1
主要终点: Change in glucose levels 15 minutes after hypoglycemic treatment

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

According to guidelines, when a mild-to-moderate hypoglycemia occurs (capillary blood glucose < 4.0 mmol/L), 15-20g of rapidly absorbed carbohydrates should be ingested. Patients should re-test and re-ingest 15-20g carbohydrates every 15 minutes until they recover from hypoglycemia. These recommendations were principally based on two studies conducted in the 80s before the introduction of intensive insulin therapy secondary to the DCCT trial and with insulin formulations with largely different pharmacokinetic profiles from current insulin analogs. Recent studies suggest that with current insulin analogs and intensive therapeutic approach, 15g of carbohydrates may be insufficient to rapidly correct an important proportion of hypoglycemic episodes. It is thus important to determine if the recommended hypoglycemia treatment remains the recommendation.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
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: 否

入选标准

•Males and females ≥ 18 years of old.
•Clinical diagnosis of type 1 diabetes for at least one year.
•Treatment with multiple daily insulin injections or insulin pump therapy and using insulin analogs (rapid, ultra-rapid and basal).
•HbA1c ≤ 10%.

排除标准

•Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
•Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
•Known significant cardiac rhythm abnormality based on investigator judgment.
•Abnormal blood panel and/or anemia (Hb < 100g/L).
•Ongoing pregnancy or breastfeeding.
•Severe hypoglycemic episode within 1 month of screening.
•Known uncorrected hypokalemia (potassium < 3.5 mmol/L; available within the past 3 months).

结局指标

主要结局

Change in glucose levels 15 minutes after hypoglycemic treatment

时间窗: 15 minutes after hypoglycemic treatment

Change in glucose levels 15 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.

次要结局

Change in glucose levels 20 minutes after hypoglycemic treatment(20 minutes after hypoglycemic treatment)
Change in glucose levels 30 minutes after hypoglycemic treatment(30 minutes after hypoglycemic treatment)
Change in glucose levels 60 minutes after hypoglycemic treatment(60 minutes after hypoglycemic treatment)
Number of patients for whom hypoglycemia was corrected 20 minutes after hypoglycemic treatment(20 minutes after hypoglycemic treatment)
Number of hypoglycemic events corrected 15 minutes after hypoglycemic treatment(15 minutes after hypoglycemic treatment)
Number of hypoglycemic events corrected 20 minutes after hypoglycemic treatment(20 minutes after hypoglycemic treatment)
Glucose levels 60 minutes after meal consumption(60 minutes after meal consumption)
Glucose levels 90 minutes after meal consumption(90 minutes after meal consumption)
Number of patients for whom hypoglycemia was corrected 35 minutes after hypoglycemic treatment(35 minutes after hypoglycemic treatment)
Number of hypoglycemic events corrected 35 minutes after hypoglycemic treatment(35 minutes after hypoglycemic treatment)
Change in glucose levels 45 minutes after hypoglycemic treatment(45 minutes after hypoglycemic treatment)
Number of patients for whom hypoglycemia was corrected 10 minutes after hypoglycemic treatment(10 minutes after hypoglycemic treatment)
Number of patients for whom hypoglycemia was corrected 25 minutes after hypoglycemic treatment(25 minutes after hypoglycemic treatment)
Number of patients for whom hypoglycemia symptoms disappeared 15 minutes after hypoglycemic treatment(15 minutes after hypoglycemic treatment)
Number of patients for whom hypoglycemia symptoms disappeared 35 minutes after hypoglycemic treatment(35 minutes after hypoglycemic treatment)
Number of patients requiring a second treatment 40 minutes after the first hypoglycemic treatment(40 minutes after the first hypoglycemic treatment)
Number of participants with glucose levels above 8.0 mmol/L 1 hour after hypoglycemia correction(60 minutes after hypoglycemia correction)
Number of participants with glucose levels above 10.0 mmol/L 1 hour after hypoglycemia correction(60 minutes after hypoglycemia correction)
Number of patients for whom hypoglycemia symptoms disappeared 10 minutes after hypoglycemic treatment(10 minutes after hypoglycemic treatment)
Number of patients for whom hypoglycemia symptoms disappeared 25 minutes after hypoglycemic treatment(25 minutes after hypoglycemic treatment)
Number of patients requiring a second treatment 15 minutes after the first hypoglycemic treatment(15 minutes after the first hypoglycemic treatment)
Number of patients for whom hypoglycemia was corrected 15 minutes after hypoglycemic treatment(15 minutes after hypoglycemic treatment)
Number of patients for whom hypoglycemia was corrected 30 minutes after hypoglycemic treatment(30 minutes after hypoglycemic treatment)
Number of hypoglycemic events corrected 10 minutes after hypoglycemic treatment(10 minutes after hypoglycemic treatment)
Number of hypoglycemic events corrected 25 minutes after hypoglycemic treatment(25 minutes after hypoglycemic treatment)
Number of hypoglycemic events corrected 30 minutes after hypoglycemic treatment(30 minutes after hypoglycemic treatment)
Number of patients for whom hypoglycemia symptoms disappeared 20 minutes after hypoglycemic treatment(20 minutes after hypoglycemic treatment)
Number of patients for whom hypoglycemia symptoms disappeared 30 minutes after hypoglycemic treatment(30 minutes after hypoglycemic treatment)

研究者

发起方

Institut de Recherches Cliniques de Montreal

申办方类型

Other

责任方

Principal Investigator

主要研究者

Rémi Rabasa-Lhoret

Full professor

Institut de Recherches Cliniques de Montreal

研究点 (1)

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