Type 2 Diabetes Clinical Trial
Official title:
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.
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