Developing a Model to Predict Inpatient Hypoglycemic Episodes

NCT ID: NCT05989256

Last Updated: 2024-08-29

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-01-31

Brief Summary

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This study will create a new model to predict hypoglycemic events in diabetic inpatients on anti-hyperglycemic therapy using retrospective data with the goal of developing a model that will accurately predict hypoglycemic episodes in the patient population - piloting the risk score that was developed in the context of EndoTool being rolled out at the institution, to determine the feasibility and acceptability of viewing the risk score in the Electronic Health Record

Detailed Description

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Design a model to predict hypoglycemic episodes in real time, rather than retrospectively identifying high risk patients who experienced a hypoglycemic event at some point during their hospitalization, as has been done prior. Potential predictors of hypoglycemia identified in prior work and additional predictors identified by the clinical team to develop a discrete-time multinomial logistic regression model to predict hypoglycemic events in real time. The risk score then will be piloted in the context of our institution's EndoTool Subcutaneous implementation determine the feasibility and acceptability of viewing the risk score in the Electronic Health Record

Conditions

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Hypoglycemic Events Hyperglycemic Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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experimental hypoglycemia risk score is applied on a service which has already implemented EndoTool

Service where the experimental hypoglycemia risk score is applied on a service which has already implemented EndoTool

Group Type EXPERIMENTAL

EndoTool

Intervention Type DIAGNOSTIC_TEST

EndoTool is a vendor based glucose management software

Service where EndoTool is applied without the experimental hypoglycemia risk score

Service where EndoTool is applied without our experimental hypoglycemia risk score

Group Type ACTIVE_COMPARATOR

glucose management team

Intervention Type OTHER

comparison group will be services that have not yet implemented EndoTool

Standard of care glucose management

Service which has not yet implemented EndoTool - providers adjusting insulin and consulting the Glucose Management Team at their discretion

Group Type ACTIVE_COMPARATOR

standard of care glucose management

Intervention Type OTHER

providers adjusting insulin and consulting the Glucose Management Team at their discretion

Interventions

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EndoTool

EndoTool is a vendor based glucose management software

Intervention Type DIAGNOSTIC_TEST

glucose management team

comparison group will be services that have not yet implemented EndoTool

Intervention Type OTHER

standard of care glucose management

providers adjusting insulin and consulting the Glucose Management Team at their discretion

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Providers taking care of adult patients (18 years and older) on the selected medical floors who are receiving anti-hyperglycemic medications on the chosen services (EndoTool and risk score implementation) and comparison groups (one group with EndoTool implementation and the other group without EndoTool implementation)

Exclusion Criteria

* Providers not on the chosen services
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Gorris, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00079298

Identifier Type: -

Identifier Source: org_study_id

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