Type 1 Diabetes Mellitus Clinical Trial
Official title:
Development and Efficacy of Individualized Professional Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus
Continuous glucose monitoring (CGM) and insulin pump, a new medical device, have been proved
and highly recommended in the treatment of type 1 diabetes patients worldwide, and related
technology development and market are growing rapidly.
In order to maximize the medical and socioeconomic effects of the latest blood glucose
devices including CGM and insulin pump, structured education is necessary. In this study, we
will develop patient-oriented structured education for patients with type 1 diabetes mellitus
when applying CGM, and we will assess the efficacy of this education protocol for patients
with type 1 diabetes using CGM.
In 50 patients with type 1 diabetes with over 7% of glycated hemoglobin, whose blood glucose
level is not well controlled, and who are undergoing multiple daily insulin injection therapy
or insulin pump therapy, continuous glucose monitoring (CGM) is applied to obtain basal
continuous glucose levels for 1 week (window period of 2 week).
These 50 patients are 1:1 randomly assigned to 2 groups including control group and
intervention group. Control group (n=25) applied CGM without structured education and after 3
months of applying CGM, continuous glucose data for 2 consecutive weeks and HbA1c level, and
other glycometabolic parameters are collected. As a sequential extension clinical trial,
those 25 patients in control group are provided structured education, followed by applying
CGM for 3 months. Continuous glucose levels for 2 consecutive weeks and HbA1c level, and
other glycometabolic parameters are collected.
In Intervention group (n=25), structured education program is provided for each patient from
the time of enrollment, followed by applying CGM for 3 months. Continuous glucose levels for
2 consecutive weeks and HbA1c level and other blood tests are performed after the 3 months.
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