DiabetesNCT04694326
The Incidence of Diabetes Unawareness in Patients Hospitalized Outside Internal Medicine Services and Related Factors
An observational study of Diabetes and Hba1c, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
Our purpose is to determine the prevalence of undiagnosed diabetes by checking HbA1c in patients hospitalized outside internal medicine services and assess whether or not there is a difference between those without diabetes awareness and those with known diabetes in terms of age, sex, education status, presence of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Hba1c, Inpatient Facililty Diagnoses
- What is being tested?
- HbA1c
- How many people
- 630 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2017to 31 Dec 2017
- How long will I take part?
- 14 Days
- 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
- Adult, Older adult
Study population: The study was conducted at two different tertiary healthcare institutions located in Istanbul in Turkey. Patientswho were inpatients of units other than internal medicine services and internal medicine side-branch services at or over the age of 18 whose anthropometric measurements could be made were included. . The internal units included neurology, dermatology, physiotherapy and rehabilitation, cardiology, infectious diseases and pulmonology services, while the surgical units included general surgery, cardiovascular surgery, pulmonary surgery, orthopedics and traumatology, brain surgery, ophthalmology, urology, gynecology and plastic surgery services.
Who may be able to join
- Inpatients of units other than internal medicine services and internal medicine side-branch services at or
- Over the age of 18
- Anthropometric measurements could be made were included
Who cannot join
- Had comorbidities that could affect their anthropometric measurements (heart failure, edema, liver cirrhosis, cancer, cachexia, Cushing syndrome, etc.),
- Who had been using steroids for more than a month,
- Pregnant
- Postoperative period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan Abdülhamid Han Training and Research Hospital
Istanbul, 34660
About this study
Official title: The Incidence of Diabetes Unawareness in Patients Hospitalized Outside Internal Medicine Services and Related Factors: A Multidisciplinary Study for Detecting Undiagnosed Diabetes
Our purpose is to determine the prevalence of undiagnosed diabetes by checking HbA1c in patients hospitalized outside internal medicine services and assess whether or not there is a difference between those without diabetes awareness and those with known diabetes in terms of age, sex, education status, presence of comorbidity and Body Mass Index (BMI).
Read the detailed description
The study included 630 patients hospitalized outside internal medicine services and internal medicine side-branch services at or over the age of 18 whose anthropometric measurements could be made. The sociodemographic properties and comorbidities of the patients were recorded. Their anthropometric measurements, fasting blood glucose and HbA1c measurements were made. Those with a previous diagnosis of diabetes were grouped as 'Known Diabetes', those without a known diabetes diagnosis but with an HbA1c value of ≥6.5% during hospitalization were grouped as 'Diabetes Unaware', and those with an HbA1C value of <6.5% were grouped as 'No Diabetes'. Whether or not there were differences among the 3 groups based on sociodemographic characteristics, anthropometric measurements and disease statuses was examined.
- Conditions
- Diabetes, Hba1c, Inpatient Facililty Diagnoses
- Being tested
- HbA1c
- Keywords
- Diabetes Mellitus, Diabetes Unawareness, İnpatient, HbA1c
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HbA1cDiagnostic test
Also called Anthropometric measures, Glucose
The participants' age, sex, education level, known diseases, unit of hospitalization and inpatient diagnosis were questioned and recorded. Height, weight and waist circumference measurements were taken. Fasting blood sugar and HbA1c measurements were made
| Study group | Role | What they receive |
|---|---|---|
| Inpatients | Patients who were inpatients of units other than internal medicine services and internal medicine side-branch services Receives: Diagnostic Test: HbA1c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Unawaraness Prevalance
Diabetes unawaraness prevalance in inpatient settings
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start20 Apr 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 630 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694326
- Sponsor's protocol ID
- INPATİENTA1C
- Status last verified
- Jan 2021
- First submitted
- 1 Jan 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Diabetes Unawareness in Patients Hospitalized Outside Internal Medicine Services and Related Factors: A Multidisciplinary Study for Detecting Undiagnosed Diabetes
- ClinicalTrials.gov ID
- NCT04694326
- Acronym / sponsor ID
- INPATİENTA1C
- Conditions
- Diabetes, Hba1c, Inpatient Facililty Diagnoses
- Keywords
- Diabetes Mellitus, Diabetes Unawareness, İnpatient, HbA1c
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 5 Jan 2021 (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.
Our purpose is to determine the prevalence of undiagnosed diabetes by checking HbA1c in patients hospitalized outside internal medicine services and assess whether or not there is a difference between those without diabetes awareness and those with known diabetes in terms of age, sex, education status, presence of comorbidity and Body Mass Index (BMI).
Detailed description
The study included 630 patients hospitalized outside internal medicine services and internal medicine side-branch services at or over the age of 18 whose anthropometric measurements could be made. The sociodemographic properties and comorbidities of the patients were recorded. Their anthropometric measurements, fasting blood glucose and HbA1c measurements were made. Those with a previous diagnosis of diabetes were grouped as 'Known Diabetes', those without a known diabetes diagnosis but with an HbA1c value of ≥6.5% during hospitalization were grouped as 'Diabetes Unaware', and those with an HbA1C value of <6.5% were grouped as 'No Diabetes'. Whether or not there were differences among the 3 groups based on sociodemographic characteristics, anthropometric measurements and disease statuses was examined.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 14 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatients | – | Diagnostic Test: HbA1cPatients who were inpatients of units other than internal medicine services and internal medicine side-branch services |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study was conducted at two different tertiary healthcare institutions located in Istanbul in Turkey. Patientswho were inpatients of units other than internal medicine services and internal medicine side-branch services at or over the age of 18 whose anthropometric measurements could be made were included. . The internal units included neurology, dermatology, physiotherapy and rehabilitation, cardiology, infectious diseases and pulmonology services, while the surgical units included general surgery, cardiovascular surgery, pulmonary surgery, orthopedics and traumatology, brain surgery, ophthalmology, urology, gynecology and plastic surgery services.
Key inclusion criteria (3 listed)
- Inpatients of units other than internal medicine services and internal medicine side-branch services at or
- Over the age of 18
- Anthropometric measurements could be made were included
Key exclusion criteria (4 listed)
- Had comorbidities that could affect their anthropometric measurements (heart failure, edema, liver cirrhosis, cancer, cachexia, Cushing syndrome, etc.),
- Who had been using steroids for more than a month,
- Pregnant
- Postoperative period
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 |
|---|---|---|
| HbA1cAlso: Anthropometric measures, GlucoseThe participants' age, sex, education level, known diseases, unit of hospitalization and inpatient diagnosis were questioned and recorded. Height, weight and waist circumference measurements were taken. Fasting blood sugar and HbA1c measurements were made | Diagnostic test | Inpatients |
Primary outcome
Diabetes Unawaraness Prevalance
Time frame: 14 days
Diabetes unawaraness prevalance in inpatient settings
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 5 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Hba1c, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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 4 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 5 Mar 2021. 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 Turkey (Türkiye). 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?
Diabetes Unawaraness Prevalance (time frame: 14 days). 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 5 Mar 2021.