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Clinical Trials/NCT05989256
NCT05989256
Withdrawn
Not Applicable

Developing a Model to Predict Inpatient Hypoglycemic Episodes

Wake Forest University Health Sciences1 site in 1 countryOctober 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypoglycemic Events
Sponsor
Wake Forest University Health Sciences
Locations
1
Primary Endpoint
EndoTool Utilization Rates
Status
Withdrawn
Last Updated
last year

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
October 2024
End Date
January 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

EndoTool Utilization Rates

Time Frame: day 90

rate of EndoTool utilization

Provider satisfaction scores

Time Frame: day 90

provider satisfaction with the alert system via survey data - 10 question survey asking Providers about their thoughts about the hypoglycemia risk score - range will be reported as their a-e answers - The provider satisfaction score ranges from 0-10 with higher scores meaning higher satisfaction.

Inpatient hypoglycemia event rates

Time Frame: day 90

Total number of hypoglycemic events (\<70 mg/dL) that were preceded by administration of rapid/short-acting insulin within 12 hours or an anti-diabetic agent other than short-acting insulin within 24 hours, were not followed by another glucose value greater than 80 mg/dL within five minutes, and were at least 20 hours apart divided by the total number of hospital days with at least one anti-diabetic agent administered)

Glucose Monitoring Team (GMT) Consult Utilization Rates

Time Frame: day 90

rate of GMT utilization

Secondary Outcomes

  • Number of Inpatient hospitalizations with a hyperglycemic event(day 90)

Study Sites (1)

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