Feasibility Trial Using an Inpatient Insulin Dosing Calculator

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Initial insulin dosing using the calculator

• Registration Number: NCT06206525
• Lead Sponsor: University of Washington

Brief Summary

The goal of this feasibility trial is to test whether a novel insulin dosing calculator can improve blood glucose management for patients with type 2 diabetes mellitus on hospital admission. The main questions it aims to answer are:

* Whether using this calculator leads to no excessive hypoglycemia?

* Whether using this calculator leads to a decrease of hyperglycemia?

Participants will receive initial insulin doses by the calculator on hospital admission, and the rest of care will follow standard of care. Participants will be compared with patients in the UW observational cohort who received initial insulin doses by standard of care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-16
• Study Start: 2024-03-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Patients who are admitted to University of Washington Medical Centers
• With history of type 2 and/or steroid-induced diabetes mellitus
• Receiving insulin therapy prior to admission

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Exclusion Criteria

• Patients who are admitted to ICU or obstetrics ward
• Patients who are admitted for elective surgery or procedure
• Patients who present with diabetic ketone acidosis, hyperosmolar hyperglycemic state or require intravenous insulin infusion
• Patients who have no meal intake for 24 hours prior to admission, or planned nothing per oral (NPO) during the first 24 hours after admission
• Patients who report low appetite (25% or less) on admission or have a significantly decreased level of consciousness that they unlikely eat right after admission
• Patients who receive enteral feeding after admission

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insulin dosing calculator	Initial insulin dosing using the calculator	-

Primary Outcome Measures

Name	Time	Method
Clinical significant hypoglycemia	During the first 48 hours after admission	Participates who develop blood glucose concentration lower than 54 mg/dL

Secondary Outcome Measures

Name	Time	Method
Mean blood glucose concentration (mg/dL)	During the first 24 hours after admission
Hypoglycemia lower than 70 mg/dL	During the first 48 hours after admission	Participates who develop blood glucose concentration lower than 70 mg/dL
Clinical significant hyperglycemia	During the first 48 hours after admission	Participates who develop blood glucose concentration higher or equal to 300 mg/dL

Trial Locations

Locations (3)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

UW Medical Center - Northwest; 🇺🇸 Seattle, Washington, United States

UW Medical Center - Montlake; 🇺🇸 Seattle, Washington, United States