Feasibility Trial Using an Inpatient Insulin Dosing Calculator

NCT ID: NCT06206525

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-22

Study Completion Date

2025-05-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin dosing calculator

Group Type EXPERIMENTAL

Initial insulin dosing using the calculator

Intervention Type OTHER

Participants will receive initial insulin doses by the calculator on hospital admission.

Interventions

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Initial insulin dosing using the calculator

Participants will receive initial insulin doses by the calculator on hospital admission.

Intervention Type OTHER

Eligibility Criteria

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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 they unlikely eat right after admission
* Patients who receive enteral feeding after admission
* Patients who develop severe acute kidney injury needing dialysis therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Hou-Hsien Chiang

Clinician researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hou-Hsien Chiang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Harborview Medical Center

Seattle, Washington, United States

Site Status

UW Medical Center - Northwest

Seattle, Washington, United States

Site Status

UW Medical Center - Montlake

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Murad MH, Coburn JA, Coto-Yglesias F, Dzyubak S, Hazem A, Lane MA, Prokop LJ, Montori VM. Glycemic control in non-critically ill hospitalized patients: a systematic review and meta-analysis. J Clin Endocrinol Metab. 2012 Jan;97(1):49-58. doi: 10.1210/jc.2011-2100. Epub 2011 Nov 16.

Reference Type BACKGROUND
PMID: 22090269 (View on PubMed)

Farrugia Y, Mangion J, Fava MC, Vella C, Gruppetta M. Inpatient hyperglycaemia, and impact on morbidity, mortality and re-hospitalisation rates. Clin Med (Lond). 2022 Jul;22(4):325-331. doi: 10.7861/clinmed.2022-0112.

Reference Type BACKGROUND
PMID: 35882487 (View on PubMed)

Bersoux S, Cook CB, Kongable GL, Shu J, Zito DR. Benchmarking glycemic control in u.s. Hospitals. Endocr Pract. 2014 Sep;20(9):876-83. doi: 10.4158/EP13516.OR.

Reference Type BACKGROUND
PMID: 24641927 (View on PubMed)

Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, Puig A, Mejia R. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). Diabetes Care. 2007 Sep;30(9):2181-6. doi: 10.2337/dc07-0295. Epub 2007 May 18.

Reference Type BACKGROUND
PMID: 17513708 (View on PubMed)

Umpierrez GE, Smiley D, Hermayer K, Khan A, Olson DE, Newton C, Jacobs S, Rizzo M, Peng L, Reyes D, Pinzon I, Fereira ME, Hunt V, Gore A, Toyoshima MT, Fonseca VA. Randomized study comparing a Basal-bolus with a basal plus correction insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes: basal plus trial. Diabetes Care. 2013 Aug;36(8):2169-74. doi: 10.2337/dc12-1988. Epub 2013 Feb 22.

Reference Type BACKGROUND
PMID: 23435159 (View on PubMed)

Umpierrez GE, Hellman R, Korytkowski MT, Kosiborod M, Maynard GA, Montori VM, Seley JJ, Van den Berghe G; Endocrine Society. Management of hyperglycemia in hospitalized patients in non-critical care setting: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2012 Jan;97(1):16-38. doi: 10.1210/jc.2011-2098.

Reference Type BACKGROUND
PMID: 22223765 (View on PubMed)

Chiang HH, Surampudi P, Sood A. Determinants of initial insulin therapy for hospitalized patients with diabetes mellitus. J Diabetes Complications. 2022 Oct;36(10):108307. doi: 10.1016/j.jdiacomp.2022.108307. Epub 2022 Sep 8.

Reference Type BACKGROUND
PMID: 36116360 (View on PubMed)

ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 16. Diabetes Care in the Hospital: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S267-S278. doi: 10.2337/dc23-S016.

Reference Type BACKGROUND
PMID: 36507644 (View on PubMed)

Other Identifiers

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2T32DK007247-41

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00018906

Identifier Type: -

Identifier Source: org_study_id

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