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Completed

NCT Number: NCT06206525

Feasibility Trial Using an Inpatient Insulin Dosing Calculator

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harborview Medical Center, Seattle, Washington, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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 study team does not think they are going to eat right after admission
  • Patients who receive enteral feeding after admission
  • Patients who develop severe acute kidney injury needing dialysis therapy

Treatment and study plan

Initial insulin dosing calculator

Other

Participants received initial insulin doses by the calculator on hospital admission.

Primary outcomes

  1. Clinical Significant Hypoglycemia

    Time frame: During the first 48 hours after admission

    Participates developed blood glucose concentration lower than 54 mg/dL

Secondary outcomes

  1. Mean Blood Glucose Concentration (mg/dL)

    Time frame: During the first 24 hours after admission

    Mean of all the point-of-care blood glucose readings during the first 24 hours after admission

  2. Clinical Significant Hyperglycemia

    Time frame: During the first 48 hours after admission

    Participates developed blood glucose concentration higher or equal to 300 mg/dL

  3. Hypoglycemia Lower Than 70 mg/dL

    Time frame: During the first 48 hours after admission

    Participates developed blood glucose concentration lower than 70 mg/dL

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Feasibility Trial Using an Insulin Dosing Calculator for Patients With Type 2 Diabetes Mellitus on Hospital Admission

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2024
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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