Towards Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes With Oral Glucose at a Higher Blood Glucose Threshold
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time spent of glucose levels < 4.0 mmol/L
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. In practice, only 32-50% of patients follow the current guidelines. In addition, recent studies suggest that under current intensive insulin therapies, an initial correction with 15g of oral glucose may be insufficient to rapidly correct mild-to-moderate hypoglycemia. With the development and increasing usage of newer glucose monitoring technologies, the community is witnessing a shift in hypoglycemia management, from a reactive to a proactive approach (e.g., prevent imminent episodes rather than treating established episodes).
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 old
- •Clinical diagnosis of type 1 diabetes for at least one year
- •Treatment with multiple daily insulin injections or insulin pump therapy with insulin analogs (rapid, ultra-rapid and basal insulin)
- •A glycated hemoglobin A1c ≤ 10%
排除标准
- •Clinically significant microvascular complications: nephropathy (eGFR < 40 ml/min), severe proliferative retinopathy as judged by the investigator, neuropathy (particularly diagnosed gastroparesis)
- •Recent (< 3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)
- •Known significant cardiac rhythm abnormality based on investigator's judgement
- •Known significant neurological abnormality (e.g., seizure disorder) based on investigator's judgement
- •Ongoing pregnancy or breastfeeding
- •Severe hypoglycemia episode within 1 month of screening
- •Known uncorrected hypokalemia within the past 3 months (potassium < 3.5 mmol/L)
研究组 & 干预措施
16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L
16g of carbohydrates will be given when glucose levels are equal or below 4.5 mmol/L.
干预措施: Dexcom G6 (Device)
16g of carbohydrates - Plasma glucose < 4.0 mmol/L
16g of carbohydrates will be given when glucose levels are below 4.0 mmol/L (management per guidelines)
干预措施: Insulin (Drug)
16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L
16g of carbohydrates will be given when glucose levels are equal or below 4.5 mmol/L.
干预措施: Test to induce a decline in plasma glucose (Other)
16g of carbohydrates - Plasma glucose < 4.0 mmol/L
16g of carbohydrates will be given when glucose levels are below 4.0 mmol/L (management per guidelines)
干预措施: Test to induce a decline in plasma glucose (Other)
16g of carbohydrates - Plasma glucose < 4.0 mmol/L
16g of carbohydrates will be given when glucose levels are below 4.0 mmol/L (management per guidelines)
干预措施: Dexcom G6 (Device)
16g of carbohydrates - Plasma glucose < 4.0 mmol/L
16g of carbohydrates will be given when glucose levels are below 4.0 mmol/L (management per guidelines)
干预措施: Dex4 (Other)
16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L
16g of carbohydrates will be given when glucose levels are equal or below 4.5 mmol/L.
干预措施: Dex4 (Other)
16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L
16g of carbohydrates will be given when glucose levels are equal or below 4.5 mmol/L.
干预措施: Insulin (Drug)
16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L
16g of carbohydrates will be given when glucose levels are equal or below 5.0 mmol/L.
干预措施: Test to induce a decline in plasma glucose (Other)
16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L
16g of carbohydrates will be given when glucose levels are equal or below 5.0 mmol/L.
干预措施: Dexcom G6 (Device)
16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L
16g of carbohydrates will be given when glucose levels are equal or below 5.0 mmol/L.
干预措施: Dex4 (Other)
16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L
16g of carbohydrates will be given when glucose levels are equal or below 5.0 mmol/L.
干预措施: Insulin (Drug)
结局指标
主要结局
Time spent of glucose levels < 4.0 mmol/L
时间窗: 60 minutes after carbohydrates consumption
次要结局
- Plasma glucose levels at 15 minutes after carbohydrates consumption(15 minutes after carbohydrates consumption)
- Plasma glucose levels at 5 minutes after carbohydrates consumption(5 minutes after carbohydrates consumption)
- Plasma glucose levels at 10 minutes after carbohydrates consumption(10 minutes after carbohydrates consumption)
- Plasma glucose levels at 30 minutes after carbohydrates consumption(30 minutes after carbohydrates consumption)
- Percentage of participants for whom hypoglycemia was corrected at 30 minutes after CHO consumption(30 minutes after carbohydrates consumption)
- Percentage of participants for whom hypoglycemia was corrected at 35 minutes after CHO consumption(35 minutes after carbohydrates consumption)
- Percentage of hypoglycemic events that were corrected at 10 minutes after CHO consumption(10 minutes after carbohydrates consumption)
- Percentage of hypoglycemic events that were corrected at 20 minutes after CHO consumption(20 minutes after carbohydrates consumption)
- Percentage of participants requiring a second treatment with carbohydrates at 20 minutes after the first CHO consumption(20 minutes after carbohydrates consumption)
- Plasma glucose levels at 45 minutes after carbohydrates consumption(45 minutes after carbohydrates consumption)
- Time from CHO consumption to the lowest plasma glucose level reached(60 minutes after carbohydrates consumption)
- Plasma glucose levels at 20 minutes after carbohydrates consumption(20 minutes after carbohydrates consumption)
- Plasma glucose levels at 60 minutes after carbohydrates consumption(60 minutes after carbohydrates consumption)
- Lowest plasma glucose level eached after CHO consumption(60 minutes after carbohydrates consumption)
- Time from CHO consumption to plasma glucose < 3.5 mmol/L(60 minutes after carbohydrates consumption)
- Percentage of participants reaching hypoglycemia (< 4.0 mmol/L) after CHO consumption(60 minutes after carbohydrates consumption)
- Percentage of participants for whom hypoglycemia was corrected at 10 minutes after CHO consumption(10 minutes after carbohydrates consumption)
- Percentage of participants for whom hypoglycemia was corrected at 15 minutes after CHO consumption(15 minutes after carbohydrates consumption)
- Percentage of participants for whom hypoglycemia was corrected at 20 minutes after CHO consumption(20 minutes after carbohydrates consumption)
- Percentage of participants for whom hypoglycemia was corrected at 25 minutes after CHO consumption(25 minutes after carbohydrates consumption)
- Percentage of hypoglycemic events that were corrected at 15 minutes after CHO consumption(15 minutes after carbohydrates consumption)
- Percentage of hypoglycemic events that were corrected at 25 minutes after CHO consumption(25 minutes after carbohydrates consumption)
- Percentage of hypoglycemic events that were corrected at 30 minutes after CHO consumption(30 minutes after carbohydrates consumption)
- Percentage of hypoglycemic events that were corrected at 35 minutes after CHO consumption(35 minutes after carbohydrates consumption)
- Percentage of participants requiring a second treatment with carbohydrates at 40 minutes after the first CHO consumption(40 minutes after carbohydrates consumption)
- Percentage of participants requiring a second treatment with carbohydrates at 60 minutes after the first CHO consumption(60 minutes after carbohydrates consumption)
- Percentage of participants experiencing a rebound hyperglycemia (≥ 10.0 mmol/L) within the first hour following the first carbobydrates consumption(60 minutes after carbohydrates consumption)
研究者
Rémi Rabasa-Lhoret
Full professor
Institut de Recherches Cliniques de Montreal