Diabetes Mellitus, Type 2
Conditions
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.
Interventions
OTHERInitial insulin dosing calculator
Participants received initial insulin doses by the calculator on hospital admission.
Sponsors
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Significant Hypoglycemia | During the first 48 hours after admission | Participates developed blood glucose concentration lower than 54 mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Blood Glucose Concentration (mg/dL) | During the first 24 hours after admission | Mean of all the point-of-care blood glucose readings during the first 24 hours after admission |
| Clinical Significant Hyperglycemia | During the first 48 hours after admission | Participates developed blood glucose concentration higher or equal to 300 mg/dL |
| Hypoglycemia Lower Than 70 mg/dL | During the first 48 hours after admission | Participates developed blood glucose concentration lower than 70 mg/dL |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHou-Hsien Chiang, MD, PhD
University of Washington
Participant flow
Recruitment details
Participants were recruited by PI: Hou-Hsien Chiang at University of Washington - Montlake, Harborview and Northwest hospitals from March 2024 to May 2025.
Pre-assignment details
The observational cohort arm was historical 140 participants, and therefore, were not included in the enrollment number.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.6 year |
| Body mass index | 30.0 kg/m² |
| Body weight | 88.3 kg |
| eGFR | 50.3 mL/min/1.73m² |
| First blood glucose on presentation | 207 mg/dL |
| Glucocorticoid use | 14 Participants |
| HbA1c | 7.7 % HbA1c |
| Home insulin total daily dose | 40 units/day |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 140 |
| other Total, other adverse events | 0 / 38 | 0 / 140 |
| serious Total, serious adverse events | 0 / 38 | 0 / 140 |
Outcome results
None listed