DiabetesNCT04800861
Glycemic Control in Diabetic Hospitalized Patients
An observational study of Diabetes and Diabetes Mellitus, run by AlFayhaa General Hospital at 1 site in Iraq.
Trial summary
With the advanced management of diabetes and new innovative anti-hyperglycemic therapy hyperglycemia remains a culprit factor affecting the outcome of patients admitted to the hospital in general wards. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus
- How many people
- 120 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2021to 1 Jul 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: diabetic patients admitted in the hospital
Who may be able to join
- admitted to the hospital
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glycemic Control in Diabetic Hospitalized Patients: a Cross Sectional Study
With the advanced management of diabetes and new innovative anti-hyperglycemic therapy hyperglycemia remains a culprit factor affecting the outcome of patients admitted to the hospital in general wards. Efforts from health care providers to assess and control blood sugar by a simplified method such as certified point of care hand-sized glucometers is the fruitful protocol if the results near the target that is endorsed by well-known diabetes societies. In non-critically patients the premeal blood sugar ≤140 mg /dl and ≤ 180 mg /dl after a meal. The unstable economy and political crises with the pandemic of Covid-19 making us use a glucometer to monitor and control the fluctuation of blood sugar in order to decrease the burden on the patients and health care providers in the form of a stay in the hospital and minimize wasting laboratory resources.
- Conditions
- Diabetes, Diabetes Mellitus
- Keywords
- diabetes mellitus, hyperglycemia, glycemic control, inpatient
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic control
percentage of patients with glucose measurement (Random Blood Sugar, RBS, Fasting Blood Sugar, FBS) between 140-180 measured with bedside glucometers preferably before meals and at 6 am for fasting blood sugars or as directed by the physician
Measured: From hospital admission to hospital discharge for a median of 7 days and up to 1 month
Secondary outcomes (2)
average blood glucose value per ward
average blood glucose value per ward (medical vs. surgical vs ICU/CCU
Measured: From hospital admission to hospital discharge for a median of 7 days and up to 1 month
average per patient
average blood glucose levels per patient
Measured: From hospital admission to hospital discharge for a median of 7 days and up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Jan 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlFayhaa General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AbdulSattar J Yousif, MD, Study chair, Al-Fayhaa teaching hospitalAli Hussein A Alhamza, MD, Study chair, Al-Fayhaa teaching hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800861
- Sponsor's protocol ID
- 1121
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: unidentified patient data will be shared if requested
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Control in Diabetic Hospitalized Patients: a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04800861
- Acronym / sponsor ID
- 1121
- Conditions
- Diabetes, Diabetes Mellitus
- Keywords
- diabetes mellitus, hyperglycemia, glycemic control, inpatient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AlFayhaa General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 16 Mar 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.
With the advanced management of diabetes and new innovative anti-hyperglycemic therapy hyperglycemia remains a culprit factor affecting the outcome of patients admitted to the hospital in general wards. Efforts from health care providers to assess and control blood sugar by a simplified method such as certified point of care hand-sized glucometers is the fruitful protocol if the results near the target that is endorsed by well-known diabetes societies. In non-critically patients the premeal blood sugar ≤140 mg /dl and ≤ 180 mg /dl after a meal. The unstable economy and political crises with the pandemic of Covid-19 making us use a glucometer to monitor and control the fluctuation of blood sugar in order to decrease the burden on the patients and health care providers in the form of a stay in the hospital and minimize wasting laboratory resources.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- diabetic patients admitted in the hospital
Key inclusion criteria (1 listed)
- admitted to the hospital
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
glycemic control
Time frame: From hospital admission to hospital discharge for a median of 7 days and up to 1 month
percentage of patients with glucose measurement (Random Blood Sugar, RBS, Fasting Blood Sugar, FBS) between 140-180 measured with bedside glucometers preferably before meals and at 6 am for fasting blood sugars or as directed by the physician
2 secondary outcomes
average blood glucose value per ward
Time frame: From hospital admission to hospital discharge for a median of 7 days and up to 1 month
average per patient
Time frame: From hospital admission to hospital discharge for a median of 7 days and up to 1 month
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 27 Dec 2022.
- Individual participant dataSharing planned: Undecided. unidentified patient data will be shared if requested
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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.
AbdulSattar J Yousif, MD study chair
Al-Fayhaa teaching hospital
Ali Hussein A Alhamza, MD study chair
Al-Fayhaa teaching hospital
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 Diabetes Mellitus, run by AlFayhaa General Hospital at 1 site in Iraq.
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 1 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 27 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 Iraq. 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?
glycemic control (time frame: From hospital admission to hospital discharge for a median of 7 days and up to 1 month). 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 27 Dec 2022.