Diabetes Mellitus, Type 2SadkornaNCT04230382
The Proportion of Patients With Non-diagnosed Diabetes Type 2
An observational study of Diabetes Mellitus, Type 2, run by Institute of Nutrition, Slovenia (Nutris) at 1 site in Slovenia.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Diagnosis of diabetes (OGTT)
- How many people
- 563 participants
- Where
- 1 siteSlovenia
- Study dates
- 20 Jan 2020to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Representative population for Slovenia
Who may be able to join
- Completed Slovenian National Health and Health System Survey 2019
- Without diagnosed diabetes (self-reported information from the survey)
- Signed study conscent
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Odkrijmo Sladkorno": The Proportion of Patients With Diabetes Type 2 Who Don't Treat Disease With Medication and the Proportion of People With an Unrecognized Diabetes
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.
Read the detailed 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Diagnosis of diabetes (OGTT)
- Keywords
- Type 2 Diabetes, Untreated diabetes, Epidemiology, OGTT, oral glucose tolerance test, HbA1c, Serum magnesium
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of diabetes (OGTT)Diagnostic test
Blood sample will be collected for glucose, HbA1c and magnesium. Standard OGTT will be conducted with 75g of glucose (repeated, if disgnostic).
| Study group | Role | What they receive |
|---|---|---|
| Adults | Adults (above 18 years) with completed National Health and Health System Survey 2019 (without diagnosis of diabetes) Receives: Diagnostic Test: Diagnosis of diabetes (OGTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
OGTT
Positive oral glucose tolerance test
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start20 Jan 2020
- Primary completion15 Sep 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Public Health, Slovenia, Ministry of Health of Republic of Slovenia, Slovenian Research Agency
- Responsible party
- Sponsor
- Investigators
- Ivan Erzen, PhD, Study chair, National Institute of Public Health, SloveniaJelka Zaletel, PhD, Principal investigator, National Institute of Public Health, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230382
- Sponsor's protocol ID
- KME/0120-490/2019/9
- Acronym
- Sadkorna
- Status last verified
- Dec 2022
- First submitted
- 13 Jan 2020
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Odkrijmo Sladkorno": The Proportion of Patients With Diabetes Type 2 Who Don't Treat Disease With Medication and the Proportion of People With an Unrecognized Diabetes
- ClinicalTrials.gov ID
- NCT04230382
- Acronym / sponsor ID
- Sadkorna / KME/0120-490/2019/9
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 Diabetes, Untreated diabetes, Epidemiology, OGTT, oral glucose tolerance test, HbA1c, Serum magnesium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)University, hospital or other
- Collaborators
- National Institute of Public Health, Slovenia, Ministry of Health of Republic of Slovenia, Slovenian Research Agency
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults | – | Diagnostic Test: Diagnosis of diabetes (OGTT)Adults (above 18 years) with completed National Health and Health System Survey 2019 (without diagnosis of diabetes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Representative population for Slovenia
Key inclusion criteria (3 listed)
- Completed Slovenian National Health and Health System Survey 2019
- Without diagnosed diabetes (self-reported information from the survey)
- Signed study conscent
Key exclusion criteria (1 listed)
- /
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis of diabetes (OGTT)Blood sample will be collected for glucose, HbA1c and magnesium. Standard OGTT will be conducted with 75g of glucose (repeated, if disgnostic). | Diagnostic test | Adults |
Primary outcome
OGTT
Time frame: 2 months
Positive oral glucose tolerance test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- NIJZ Project web-site (in Slovenian language)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan Erzen, PhD study chair
National Institute of Public Health, Slovenia
Jelka Zaletel, PhD principal investigator
National Institute of Public Health, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Institute of Nutrition, Slovenia (Nutris) at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OGTT (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.