Developing a Model to Predict Inpatient Hypoglycemic Episodes

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hypoglycemic Events; Hyperglycemic Therapy
• Intervention / Treatment: Diagnostic test: EndoTool; Other: glucose management team; Other: standard of care glucose management

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

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Stern; Phone Number: 407.913.7232; Email: srstern@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
      • Contact: Sarah Stern; Phone Number: 407-913-7232; Email: srstern@wakehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Diagnostic test: EndoTool; EndoTool is a vendor based glucose management software
Active Comparator: Service where EndoTool is applied without the experimental hypoglycemia risk score; Service where EndoTool is applied without our experimental hypoglycemia risk score	Other: glucose management team; comparison group will be services that have not yet implemented EndoTool
Active Comparator: Standard of care glucose management; Service which has not yet implemented EndoTool - providers adjusting insulin and consulting the Glucose Management Team at their discretion	Other: standard of care glucose management; providers adjusting insulin and consulting the Glucose Management Team at their discretion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EndoTool Utilization Rates	rate of EndoTool utilization	day 90
Glucose Monitoring Team (GMT) Consult Utilization Rates	rate of GMT utilization	day 90
Inpatient hypoglycemia event rates	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)	day 90
Provider satisfaction scores	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.	day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Inpatient hospitalizations with a hyperglycemic event	Number of Inpatient hospitalizations with a hyperglycemic event within the first 10 days of the encounter minus the first 24 hours, and minus the last period before discharge if less than 24 hours. CMS defines a hyperglycemic event as a blood glucose result of >300 mg/dL, and/or a day in which a blood glucose value was not documented, and it was preceded by two consecutive days where at least one glucose value is >=200 mg/dL divided by the number of qualifying hospitalizations where the patient is 18 years or older at the start of the admission, as well as either: a diagnosis of diabetes that starts before or during the encounter; or administration of at least one dose of insulin or any hypoglycemic medication during the encounter; or presence of at least one blood glucose value >=200 mg/dL at any time during the encounter.	day 90

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Matthew Gorris, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: diabetes; hypoglycemia
• Other Study ID Numbers: IRB00079298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No