Feasibility Trial Using an Inpatient Insulin Dosing Calculator

NCT06206525 | Completed Results DMC

• 2 other identifiers: STUDY000189062T32DK007247-41
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Clinical Significant Hypoglycemia

  Participates developed blood glucose concentration lower than 54 mg/dL

  During the first 48 hours after admission

Secondary Outcomes (3)

• Mean Blood Glucose Concentration (mg/dL)

  During the first 24 hours after admission

• Clinical Significant Hyperglycemia

  During the first 48 hours after admission

• Hypoglycemia Lower Than 70 mg/dL

  During the first 48 hours after admission

Study Arms (2)

Initial insulin dosing calculator

EXPERIMENTAL

Other: Initial insulin dosing calculator

Observational cohort

NO INTERVENTION

Historical patients who received initial insulin doses by standard of care

Interventions

Initial insulin dosing calculator OTHER

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

Initial insulin dosing calculator

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

UW Medical Center - Northwest

Seattle, Washington, 98133, United States

Location

UW Medical Center - Montlake

Seattle, Washington, 98195, United States

Location

Related Publications (8)

• 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.

  PMID: 22090269 BACKGROUND

• 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.

  PMID: 35882487 BACKGROUND

• 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.

  PMID: 24641927 BACKGROUND

• 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.

  PMID: 17513708 BACKGROUND

• 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.

  PMID: 23435159 BACKGROUND

• 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.

  PMID: 22223765 BACKGROUND

• 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.

  PMID: 36116360 BACKGROUND

• 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.

  PMID: 36507644 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

* Single-arm feasibility study which does not include a control arm * Relatively small sample size to detect a rare outcome or adverse event * Single center study

Results Point of Contact

• Title: Clinician researcher
• Organization: University of Washington

htchiang@uw.edu

206-221-5705

Study Officials

• Hou-Hsien Chiang, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician researcher

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: March 22, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: May 11, 2026
• Results First Posted: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)