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| ID | Type | Description | Link |
|---|---|---|---|
| 2T32DK007247-41 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial insulin dosing calculator | Experimental |
| |
| Observational cohort | No Intervention | Historical patients who received initial insulin doses by standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Initial insulin dosing calculator | Other | Participants received initial insulin doses by the calculator on hospital admission. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Significant Hypoglycemia | Participates developed blood glucose concentration lower than 54 mg/dL | During the first 48 hours after admission |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Blood Glucose Concentration (mg/dL) | Mean of all the point-of-care blood glucose readings during the first 24 hours after admission | During the first 24 hours after admission |
| Clinical Significant Hyperglycemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hou-Hsien Chiang, MD, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview Medical Center | Seattle | Washington | 98104 | United States | ||
| UW Medical Center - Northwest |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22090269 | Background | 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. | |
| 35882487 | 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. |
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Data sharing will be considered only on a collaborative basis with PIs, after evaluation of the proposed study protocol and statistical analysis plan.
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The observational cohort arm was historical 140 participants, and therefore, were not included in the enrollment number.
Participants were recruited by PI: Hou-Hsien Chiang at University of Washington - Montlake, Harborview and Northwest hospitals from March 2024 to May 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Initial Insulin Dosing Calculator | Participants received initial insulin doses by the calculator on hospital admission |
| FG001 | Observational Cohort | Historical patients who received initial insulin doses by standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Initial Insulin Dosing Calculator | Participants received initial insulin doses by the calculator on hospital admission |
| BG001 | Observational Cohort | Historical patients who received initial insulin doses by standard of care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Significant Hypoglycemia | Participates developed blood glucose concentration lower than 54 mg/dL | All participants received at least the first dose by the calculator before clinicians adjusted their insulin doses | Posted | Count of Participants | Participants | During the first 48 hours after admission |
|
from hospital admission until 48 hours after admission
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Initial Insulin Dosing Calculator | Participants received initial insulin doses by the calculator on hospital admission |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinician researcher | University of Washington | 206-221-5705 | htchiang@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2025 | Mar 8, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Participates developed blood glucose concentration higher or equal to 300 mg/dL
| During the first 48 hours after admission |
| Hypoglycemia Lower Than 70 mg/dL | Participates developed blood glucose concentration lower than 70 mg/dL | During the first 48 hours after admission |
| Seattle |
| Washington |
| 98133 |
| United States |
| UW Medical Center - Montlake | Seattle | Washington | 98195 | United States |
| 24641927 | 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. |
| 17513708 | 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. |
| 23435159 | 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. |
| 22223765 | 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. |
| 36116360 | 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. |
| 36507644 | 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. |
| BG002 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body weight | Median | Inter-Quartile Range | kg |
|
| Body mass index | Median | Inter-Quartile Range | kg/m² |
|
| eGFR | Median | Inter-Quartile Range | mL/min/1.73m² |
|
| HbA1c | Median | Inter-Quartile Range | % HbA1c |
|
| Glucocorticoid use | Count of Participants | Participants |
|
| Home insulin total daily dose | Median | Inter-Quartile Range | units/day |
|
| First blood glucose on presentation | Median | Inter-Quartile Range | mg/dL |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Mean Blood Glucose Concentration (mg/dL) | Mean of all the point-of-care blood glucose readings during the first 24 hours after admission | All participants received at least the first dose by the calculator before clinicians adjusted their insulin doses | Posted | Mean | Standard Deviation | mg/dL | During the first 24 hours after admission |
|
|
|
|
| Secondary | Clinical Significant Hyperglycemia | Participates developed blood glucose concentration higher or equal to 300 mg/dL | Posted | Count of Participants | Participants | During the first 48 hours after admission |
|
|
|
|
| Secondary | Hypoglycemia Lower Than 70 mg/dL | Participates developed blood glucose concentration lower than 70 mg/dL | All participants received at least the first dose by the calculator before clinicians adjusted their insulin doses | Posted | Count of Participants | Participants | During the first 48 hours after admission |
|
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Observational Cohort | Historical patients who received initial insulin doses by standard of care | 0 | 140 | 0 | 140 | 0 | 140 |
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| D004700 | Endocrine System Diseases |