Developing a Model to Predict Inpatient Hypoglycemic Episodes

NCT05989256 | Withdrawn FDA Device

• 1 other identifier: IRB00079298
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Hypoglycemic Events; Hyperglycemic Therapy

Keywords

diabetes; hypoglycemia

Outcome Measures

Primary Outcomes (4)

• EndoTool Utilization Rates

  rate of EndoTool utilization

  day 90

• Glucose Monitoring Team (GMT) Consult Utilization Rates

  rate of GMT utilization

  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

• 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

Secondary Outcomes (1)

• Number of Inpatient hospitalizations with a hyperglycemic event

  day 90

Study Arms (3)

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

EXPERIMENTAL

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

Diagnostic Test: EndoTool

Service where EndoTool is applied without the experimental hypoglycemia risk score

ACTIVE COMPARATOR

Service where EndoTool is applied without our experimental hypoglycemia risk score

Other: glucose management team

Standard of care glucose management

ACTIVE COMPARATOR

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

Interventions

EndoTool DIAGNOSTIC_TEST

EndoTool is a vendor based glucose management software

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

glucose management team OTHER

comparison group will be services that have not yet implemented EndoTool

Service where EndoTool is applied without the experimental hypoglycemia risk score

standard of care glucose management OTHER

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

Standard of care glucose management

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Providers not on the chosen services

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Matthew Gorris, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 14, 2023
• Study Start: October 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 29, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)