Investigation of Critically Ill Patients With Newly Diagnosed Diabetes

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).

Completed

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stamford Health

Stamford, Connecticut, 06902, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Treatment and study plan

Diabetes Diagnosis

Diagnostic Test

HbA1c > 6.5%

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Stamford Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2019
Study completion: 2022
First posted: Feb 25, 2022
Registry last updated: Feb 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed