Investigation of Critically Ill Patients With Newly Diagnosed Diabetes

Completed

• Conditions: Diabetes Mellitus
• Interventions: Diagnostic Test: Diabetes Diagnosis

• Registration Number: NCT05256043
• Lead Sponsor: Stamford Hospital

Brief 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).

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 Timeline

• Study Start: 2011-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2022-01-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-24
• Last Update Submitted: 2022-02-24
• Study First Posted: 2022-02-25
• Last Update Posted: 2022-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1777

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Target Population	Diabetes Diagnosis	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).

Primary Outcome Measures

Name	Time	Method
Inpatient mortality	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	2011-2019	Total days spent admitted to the hospital

Trial Locations

Locations (1)

Stamford Health; 🇺🇸 Stamford, Connecticut, United States