Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04230382 |
| Other study ID # |
KME/0120-490/2019/9 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2020 |
| Est. completion date |
April 30, 2022 |
Study information
| Verified date |
December 2022 |
| Source |
Nutrition Institute, Slovenia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aims of the study are to determine the prevalence of diabetes in subgroups of the
population with certain characteristics (age, gender, socioeconomic status, geographical area
of residence), to estimate the proportion of those patients with diabetes treated without
drugs, to estimate the proportion of the patients in which diabetes is not yet diagnosed, and
to develop a proposal and recommendations for the development, implementation and evaluation
of programs for the prevention and early diagnosis of diabetes.
An analysis of the prevalence of diabetes in population subgroups and an estimate of the
proportion of those patients who have non-drug treated diabetes will be drawn upon the data
from the National Health and Health System Survey 2019, run by National Institute of Public
Health. Methodologically it is a cross-sectional survey using a survey questionnaire based on
the European Health Interview Survey. A sample of 16,000 inhabitants is invited to
participate. The database contains sets of questions about health status, health markers and
health care, and contains all the information that the research project covers. All those
interviewees from the National Health and Health System Survey 2019 who are not aware to have
diabetes will be invited to the health examination survey. They will be invited to perform an
oral glucose tolerance test (once or twice, based on the results). In this way, diabetes can
be diagnosed in those individuals who already have diabetes, but have not yet been aware of
it. Secondary analyses of the data and the measurement of HbA1c from the sample of blood
taken at the same collection will also give the opportunity to assess for example, the
prevalence of impaired fasting glucose, impaired glucose tolerance, their combinations, and
obtain more data on the clinical meaning of oral glucose tolerance test versus HbA1c in
diagnosing diabetes in Slovenian context. We estimate that approximately 1500-2000 people
will perform the health examination survey part.
Description:
National Diabetes Program 2010-2020 is a strategic document of Slovenia aimed at reducing the
incidence of type 2 diabetes, preventing type 2 diabetes in people at highreducing the
incidence of type 2 diabetes, preventing type 2 diabetes in people at high risk, early
diagnosis of diabetes and reducing complications and diabetes mortality. Diabetes is one of
the most common reasons why the inhabitants of Slovenia visit a doctor, while extending life
expectancy and aging of the population will additionally increase these needs. In order to
evaluate the activities that are already being implemented and to guide further activities in
Slovenia, a high-quality analysis is needed to evaluate the prevalence of diabetes in people
with specific characteristics, the estimation of the proportion of patients who are treating
diabetes without drugs and the estimate of the proportion of those patients whose diabetes is
not yet detected.
The prevalence of diabetes in certain population subgroups, in particular in relation to age,
gender, socioeconomic status and geographical area of residence, is important for assessing
the current burden of the disease and for predicting the needs in the future. These analyses
can lead to adaptation of measures in the health system and, depending on the needs
identified, also outside health system. A more accurate estimate of the proportion of
patients who are treating diabetes without drugs will enable a more accurate calculation of
the number of patients with diabetes in Slovenia. This will also improve the accuracy of
calculating the burden of the disease today and in the future. Above all, in order to be
accurate in predicting the burden in the future, a reliable estimate of the proportion of
patients who already have diabetes but who are not already aware of it and their
characteristics are important. Such an analysis is also a key feedback on the effectiveness
of existing prevention and early detection programs for diabetes and a basis for adjusting
measures in this area.
The aims of the research project are therefore to determine the prevalence of diabetes in
subgroups of the population with certain characteristics (age, gender, socioeconomic status,
geographical area of residence), to estimate the proportion of those patients with diabetes
treated without drugs, to estimate the proportion of the patients in which diabetes is not
yet diagnosed, and to develop a proposal and recommendations for the development,
implementation and evaluation of programs for the prevention and early diagnosis of diabetes.
An analysis of the prevalence of diabetes in population subgroups and an estimate of the
proportion of those patients who have non-drug treated diabetes will be drawn upon the data
from the National Health and Health System Survey 2019, run by National Institute of Public
Health. Methodologically it is a cross-sectional survey using a survey questionnaire based on
the European Health Interview Survey.
A sample of 16,000 inhabitants was invited to participate. The database contains sets of
questions about health status, health markers and health care, and contains all the
information that the research project covers. Secondary analyses of the collected data will
also allow evaluation of some other characteristics of the population, such as, for example,
lifestyle characteristics, body weight, score by FINDRISC for the assessment of the risk of
diabetes, and considering that the survey is conducted for the third time, some of the trends
that are important for the analysis of future needs and proper planning of the activity in
the future can also be developed. In order to prepare a methodologically relevant assessment
of the proportion of patients with diabetes in Slovenia in whom diabetes is not yet
diagnosed, a cross-sectional survey will be carried out using a Health Examination Survey
approach. All those interviewees from the National Health and Health System Survey 2019 who
are not aware to have diabetes will be invited to the health examination survey. An oral
glucose tolerance test Will be performed (once or twice, based on the results). In this way,
diabetes can be diagnoses in those individuals who already have diabetes, but have not yet
been aware of it. Secondary analyses of the data and the measurement of HbA1c from the sample
of blood taken at the same collection will also give the opportunity to assess for example,
the prevalence of impaired fasting glucose, impaired glucose tolerance, their combinations,
and obtain more data on the clinical meaning of oral glucose tolerance test versus HbA1c in
diagnosing diabetes in Slovenian context. It is estimated that approximately 1500-2000 people
will perform the health examination survey part. The research protocol was approved by the
Republic Medical Ethics Committee. The survey will be conducted in accordance with all
ethical standards that relates to the volunteers in such studies, including providing
feedback, what is the importance of the results for in such studies, including providing
feedback, what is the importance of the results for them personally, and will give them the
instructions for the use of healthcare system, if appropriate. Data and their identity will
also be protected.
In 2007 and 2014, the constellation of questions in national health and health system surveys
already gave an estimate of the prevalence of diabetes in specific population subgroups. The
study will, in addition to the cross-sectional descriptions, also provide a more robust
description of the trends. On the basis of these results, an assessment of the management of
the incidence of diabetes in individual population groups in the past can be made, as well as
recommendations for the development and implementation of appropriate activities in the
future, such as the further upgrading of health promotion centres, upgrading health care
activities carried out by family medicine, and in the preparation of targeted measures in
individual population groups, including through the involvement of partners outside health
care, and with approaches to reducing inequalities and other activities of the implementation
of National Diabetes Plan 2020- 2030.
The assessment of the proportion of people with undiagnosed type 2 diabetes mellitus and
their characteristics will be made for the first time in Slovenia. People with unrecognized
chronic illnesses, including type 2 diabetes, represent those individuals with the greatest
burden of the disease, both in health and, for example, in financial and psychosocial
aspects. Undertaking approaches to reducing the proportion of people with an unrecognized
chronic disease is therefore one of the greatest health and society challenges in the next
decade, as it is an indispensable measure to ensure the sustainability of the health system
and to ensure the well-being of society.
The final task of this research project is the development of a report that will include a
proposal and recommendations for the development, implementation and evaluation of programs
for the prevention and early diagnosis of diabetes, which will represent the so-called
evidence-informed policy making, risk, early diagnosis of diabetes and reducing complications
and diabetes mortality.
