Investigation of Critically Ill Patients With Newly Diagnosed Diabetes

NCT ID: NCT05256043

Last Updated: 2022-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1777 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2022-01-01

Brief Summary

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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

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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

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Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

Diabetes Diagnosis

Intervention Type DIAGNOSTIC_TEST

HbA1c \> 6.5%

Interventions

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Diabetes Diagnosis

HbA1c \> 6.5%

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stamford Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stamford Health

Stamford, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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TSH_InternalMedicine_2021010

Identifier Type: -

Identifier Source: org_study_id

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