Diabetes MellitusNCT05256043
Investigation of Critically Ill Patients With Newly Diagnosed Diabetes
An observational study of Diabetes Mellitus, run by Stamford Hospital at 1 site in United States.
Trial summary
The purpose of this study is to investigate the clinical outcomes and glucose control metrics of critically ill patients with previously undiagnosed diabetes compared to those with known diabetes at the time of admission to the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Diabetes Diagnosis
- How many people
- 1,777 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2011to 1 Jan 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU where they were subsequently diagnosed for the first time with diabetes.
Who may be able to join
- Patients admitted between 9/14/2011 and 11/30/19 with HbA1c available on admission and at least four documented blood glucose tests during their ICU stay.
Who cannot join
- Patients admitted for diabetic ketoacidosis.
- Patients admitted to the ICU following cardiovascular surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case-control Investigation of Critically Ill Patients With Newly Diagnosed Diabetes: Clinical Characteristics, Glucose Metrics and Outcomes
The purpose of this study is to investigate the clinical outcomes and glucose control metrics of critically ill patients with previously undiagnosed diabetes compared to those with known diabetes at the time of admission to the intensive care unit (ICU).
Read the detailed description
This case control study compares previously undiagnosed diabetic patients (defined as HbA1c > 6.5% and no history of diabetes), to those with known diabetes, using 1:1 matching. Patients met inclusion criteria by having HbA1c available on ICU admission and at least four blood glucose tests during their ICU stay. Primary outcomes included ICU length of stay and inpatient mortality. Secondary outcomes included glucose metrics: mean blood glucose, coefficient of variation and percentage of patients who developed hypoglycemia.
- Conditions
- Diabetes Mellitus
- Being tested
- Diabetes Diagnosis
- Keywords
- Diabetes Mellitus, Glucose Metrics, Outcome Evaluation, Intensive Care Unit
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes DiagnosisDiagnostic test
HbA1c > 6.5%
| Study group | Role | What they receive |
|---|---|---|
| Target Population | Adult patients age ≥ 18 admitted to the Stamford Hospital ICU between 9/14/11 and 11/30/19 with HbA1c available on admission and at least 4 blood glucose (BG) tests during ICU stay. Two groups were created; patients with previously undiagnosed diabetes (NDDM) compared to those with known diabetes (KDM) at the time of admission to the intensive care unit (ICU). Receives: Diagnostic Test: Diabetes Diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inpatient mortality
Estimates the risk of short-term mortality based on data from the initial 24 hours of intensive care unit (ICU) admission. Acute Physiology and Chronic Health Evaluation (APACHE) IV
Measured: 2011-2019
Length of hospital Stay
Total days spent admitted to the hospital
Measured: 2011-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Jan 2011
- Primary completion31 Dec 2019
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,777 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stamford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256043
- Sponsor's protocol ID
- TSH_InternalMedicine_2021010
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 25 Feb 2022
- 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 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-control Investigation of Critically Ill Patients With Newly Diagnosed Diabetes: Clinical Characteristics, Glucose Metrics and Outcomes
- ClinicalTrials.gov ID
- NCT05256043
- Acronym / sponsor ID
- TSH_InternalMedicine_2021010
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Glucose Metrics, Outcome Evaluation, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,777 participants (actual)
- Lead sponsor
- Stamford HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 25 Feb 2022 (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 purpose of this study is to investigate the clinical outcomes and glucose control metrics of critically ill patients with previously undiagnosed diabetes compared to those with known diabetes at the time of admission to the intensive care unit (ICU).
Detailed description
This case control study compares previously undiagnosed diabetic patients (defined as HbA1c > 6.5% and no history of diabetes), to those with known diabetes, using 1:1 matching. Patients met inclusion criteria by having HbA1c available on ICU admission and at least four blood glucose tests during their ICU stay. Primary outcomes included ICU length of stay and inpatient mortality. Secondary outcomes included glucose metrics: mean blood glucose, coefficient of variation and percentage of patients who developed hypoglycemia.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Target Population | – | Diagnostic Test: Diabetes DiagnosisAdult patients age ≥ 18 admitted to the Stamford Hospital ICU between 9/14/11 and 11/30/19 with HbA1c available on admission and at least 4 blood glucose (BG) tests during ICU stay. Two groups were created; patients with previously undiagnosed diabetes (NDDM) compared to those with known diabetes (KDM) at the time of admission to the intensive care unit (ICU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU where they were subsequently diagnosed for the first time with diabetes.
Key inclusion criteria (1 listed)
- Patients admitted between 9/14/2011 and 11/30/19 with HbA1c available on admission and at least four documented blood glucose tests during their ICU stay.
Key exclusion criteria (2 listed)
- Patients admitted for diabetic ketoacidosis.
- Patients admitted to the ICU following cardiovascular surgery.
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 |
|---|---|---|
| Diabetes DiagnosisHbA1c > 6.5% | Diagnostic test | Target Population |
Primary outcome
Inpatient mortality
Time frame: 2011-2019
Estimates the risk of short-term mortality based on data from the initial 24 hours of intensive care unit (ICU) admission. Acute Physiology and Chronic Health Evaluation (APACHE) IV
Length of hospital Stay
Time frame: 2011-2019
Total days spent admitted to the hospital
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 25 Feb 2022.
- 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 Mellitus, run by Stamford Hospital at 1 site in United States.
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 2 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 25 Feb 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 United States. 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?
Inpatient mortality (time frame: 2011-2019). The study lists 2 primary outcomes in all. 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 25 Feb 2022.