NCT05256043

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,777

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

9 years

First QC Date

February 16, 2022

Last Update Submit

February 24, 2022

Conditions

Diabetes Mellitus

Keywords

Diabetes MellitusGlucose MetricsOutcome EvaluationIntensive Care Unit

Outcome Measures

Primary Outcomes (2)

  • 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

  • Length of hospital Stay

    Total days spent admitted to the hospital

    2011-2019

Study Arms (1)

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).

Diagnostic Test: Diabetes Diagnosis

Interventions

Diabetes DiagnosisDIAGNOSTIC_TEST

HbA1c \> 6.5%

Target Population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the ICU where they were subsequently diagnosed for the first time with diabetes.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients admitted for diabetic ketoacidosis.
  • Patients admitted to the ICU following cardiovascular surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stamford Health

Stamford, Connecticut, 06902, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2022

First Posted

February 25, 2022

Study Start

January 1, 2011

Primary Completion

December 31, 2019

Study Completion

January 1, 2022

Last Updated

February 25, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)