Diabetes Mellitus Type II, Clinical Trial
Official title:
E-support for Healthcare Processes - DIABETES
The purpose of the study is to clinically evaluate a new approach to treatment of patients
with diabetes mellitus type II by using specially developed mobile-internet software
solution.
The effect of information and communication technologies (ICT) to improve the integrated
care of people with diabetes will be identified, developed, introduced and clinically
evaluated.
The investigators expect that usage of an e-Health application in health care of patients
with diabetes mellitus type II could improve the following healthcare outcomes: results of
the laboratory tests (with emphasis on HbA1C value), regular medication usage, blood
pressure values, Body mass index (BMI) values, diet, regular exercise and quality of life.
Diabetes mellitus (DM) is defined as a "group of common metabolic disorders that share the
phenotype of hyperglycemia". It is generally agreed that in Caucasian populations the
prevalence rate is between 2% and 6%. Prevalence rate of DM in SLovenia is about 5%. Type 2
DM accounts for 90% to 95% of all diabetes cases.
Results of many clinical studies demonstrated the great potential of information and
communication technology (ICT) applications to improve health care of patients with chronic
diseases including diabetes mellitus.
In this study an ICT mobile environment to improve the process of an integrated care of
people with Diabetes mellitus will be identified, developed, introduced and clinically
evaluated. The study will include 140 patients diagnosed with diabetes mellitus type II who
are managed in primary care. The study will use and evaluation questionnaire that will cover
issues regarding the patient quality of life.
Subjects with a blood pressure meter and a scale, will be able to enter the value of the
systolic and diastolic blood pressure and the body weight.
Subjects will be motivated to regularly enter data about their blood pressure, body weight,
dietary misconducts and to complete available questioners. In addition to this, users can
enter values about their physical activity (type, duration, intensity).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care