Evaluating the True Magnitude of HYPOglycemic Events After THE Initiation of Sulfonylurea

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating the True Magnitude of HYPOglycemic Events After THE Initiation of Sulfonylurea, by Continuous Glucose monItoring System: A Multicenter Study. The HYPOTHESIS Trial

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Observational


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T2DM at SU initiation<br>T2DM newly prescribed a SU | Other: Observational<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total incidence rate of hypoglycemia episode |  | One week after initiation of the SU | 
| Total incidence rate of hypoglycemia episode |  | One week at 3-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Sulfonylurea, Hypoglycemia, Quality of life