Evaluating the True Magnitude of HYPOglycemic Events After THE Initiation of Sulfonylurea
Evaluating the True Magnitude of HYPOglycemic Events After THE Initiation of Sulfonylurea, by Continuous Glucose monItoring System: A Multicenter Study. The HYPOTHESIS Trial
Sulfonylurea are known to be associated with a risk of hypoglycaemia. However, little is known about the real frequency of asymptomatic or unreported hypoglycemia and their impact on glycemic control and quality of life among patients using sulfonylureas (SUs). The frequency of hypoglycemia is probably underestimated since self-monitoring of blood glucose (SMBG) fail to identify asymptomatic episodes, especially among patients with higher risk of hypoglycemia unawareness (longer diabetes duration, elderly, recurrent hypoglycemia, etc.). No previous studies have reported total hypoglycemia as measured by continuous glucose monitoring system (CGMS) in a large group of Canadians, therefore underestimating the true incidence of these events. As with age hypoglycemia perception is reduced and consequences can be increased due to frailty, elderly could be especially sensitive to the risk of hypoglycemia. Documentation of the total number of hypoglycemia is a relevant objective to really appreciate the potential impact of SUs in the Canadian context.
The investigators propose a multicenter observational prospective study in order to study the incidence of hypoglycaemia measured by CGMS among patients with type 2 diabetes mellitus (T2DM) newly prescribed a SU. The investigators propose to perform a baseline testing (pre-initiation of the SU), at initiation (first week after the first dose of the SU) and after a 3 months follow-up of treatment, including medical history measures, quality of life and diabetes treatment satisfaction.
In patients with T2DM not at goal (A1c >7.0 mmol/L), and newly prescribed a SU, the objectives and hypotheses of the study are to estimate the incidence rate of hypoglycaemia as measured by continuous glucose monitoring system (CGMS) over a total of 3 weeks period following the initiation of the SU.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5C2T2
- University of Toronto
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Quebec
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Montreal、Quebec、加拿大、H2W1R7
- Institut de recherches cliniques de Montréal
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Type 2 diabetes according to Canadian Diabetes Association definition
- Initiation of a SU at baseline
- A1c: 7.0% to 10.0%
- Willing and able to comply with study procedures
Exclusion Criteria:
- Current or previous usage (during the last 3 months) of insulin or repaglinide
- Use of medication known to interfere with glucose metabolism
- Insulin requiring patient: catabolic state and/or ketonuria
- Currently using CGMS or within the last 3 months
- Recent severe hypoglycemia (<3 months)
- Pregnancy or breast-feeding
- Limited life expectancy, high level of functional dependency, extensive coronary disease at high risk of short term ischemic events or multiple major co-morbidities
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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T2DM at SU initiation
T2DM newly prescribed a SU
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Investigators propose to perform a one-week baseline testing (pre-initiation of the SU), at initiation (first week after the first dose of the SU) and after a 3 months follow-up of treatment with a SU, including CGMS reading, medical history measures, quality of life and diabetes treatment satisfaction.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Total incidence rate of hypoglycemia episode
大体时间:One week after initiation of the SU
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One week after initiation of the SU
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Total incidence rate of hypoglycemia episode
大体时间:One week at 3-month follow-up
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One week at 3-month follow-up
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合作者和调查者
调查人员
- 首席研究员:Rémi Rabasa-Lhoret, MD,PhD、IRCM
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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