Clinical trial NCT06206525: Feasibility Trial Using an Inpatient Insulin Dosing Calculator
Official title: Feasibility Trial Using an Insulin Dosing Calculator for Patients With Type 2 Diabetes Mellitus on Hospital Admission
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-01-16
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical significant hypoglycemia
timeFrame: During the first 48 hours after admission
Secondary outcomes:
measure: Mean blood glucose concentration (mg/dL)
timeFrame: During the first 24 hours after admission
measure: Clinical significant hyperglycemia
timeFrame: During the first 48 hours after admission
measure: Hypoglycemia lower than 70 mg/dL
timeFrame: During the first 48 hours after admission
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: UW Medical Center - Northwest
state: Washington
city: Seattle
country: United States
facility: UW Medical Center - Montlake
state: Washington
Study officials:
affiliation: University of Washington
name: Hou-Hsien Chiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.