Feasibility Trial Using an Inpatient Insulin Dosing Calculator

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206525
• Other study ID #: STUDY00018906
• Secondary ID: 2T32DK007247-41
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2024
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: Hou-Hsien Chiang, MD, PhD
• Phone: 206-221-5705
• Email: htchiang[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Initial insulin dosing using the calculator
Participants will receive initial insulin doses by the calculator on hospital admission.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington
United States	UW Medical Center - Montlake	Seattle	Washington
United States	UW Medical Center - Northwest	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical significant hypoglycemia	Participates who develop blood glucose concentration lower than 54 mg/dL	During the first 48 hours after admission
Secondary	Mean blood glucose concentration (mg/dL)		During the first 24 hours after admission
Secondary	Clinical significant hyperglycemia	Participates who develop blood glucose concentration higher or equal to 300 mg/dL	During the first 48 hours after admission
Secondary	Hypoglycemia lower than 70 mg/dL	Participates who develop blood glucose concentration lower than 70 mg/dL	During the first 48 hours after admission