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.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Ontario
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Toronto、Ontario、カナダ、M5C2T2
- University of Toronto
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Quebec
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Montreal、Quebec、カナダ、H2W1R7
- Institut de recherches cliniques de Montreal
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Total incidence rate of hypoglycemia episode
時間枠: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
時間枠:One week at 3-month follow-up
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One week at 3-month follow-up
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協力者と研究者
捜査官
- 主任研究者:Rémi Rabasa-Lhoret, MD,PhD、IRCM
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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