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Developing a Model to Predict Inpatient Hypoglycemic Episodes

Developing a Model to Predict Inpatient Hypoglycemic Episodes

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05989256
Enrollment
0
Registered
2023-08-14
Start date
2024-10-31
Completion date
2025-01-31
Last updated
2024-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemic Therapy, Hypoglycemic Events

Keywords

diabetes, hypoglycemia

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

Interventions

DIAGNOSTIC_TESTEndoTool

EndoTool is a vendor based glucose management software

OTHERglucose management team

comparison group will be services that have not yet implemented EndoTool

OTHERstandard of care glucose management

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

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
EndoTool Utilization Ratesday 90rate of EndoTool utilization
Glucose Monitoring Team (GMT) Consult Utilization Ratesday 90rate of GMT utilization
Provider satisfaction scoresday 90provider 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 ratesday 90Total 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)

Secondary

MeasureTime frameDescription
Number of Inpatient hospitalizations with a hyperglycemic eventday 90Number 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026