Investigation of Critically Ill Patients With Newly Diagnosed Diabetes

Diabetes Mellitus Clinical Trial

Official title:

Case-control Investigation of Critically Ill Patients With Newly Diagnosed Diabetes: Clinical Characteristics, Glucose Metrics and Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05256043
• Other study ID #: TSH_InternalMedicine_2021010
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: January 1, 2022

Study information

• Verified date: February 2022
• Source: Stamford Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1777
• Est. completion date: January 1, 2022
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:20

• 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.

Exclusion Criteria:

• Patients admitted for diabetic ketoacidosis.

• Patients admitted to the ICU following cardiovascular surgery.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Diagnostic Test:
• Diabetes Diagnosis
HbA1c > 6.5%

Locations

Country	Name	City	State
United States	Stamford Health	Stamford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Stamford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2011-2019
Primary	Length of hospital Stay	Total days spent admitted to the hospital	2011-2019