Trial Outcomes & Findings for Feasibility Trial Using an Inpatient Insulin Dosing Calculator (NCT NCT06206525)
NCT ID: NCT06206525
Last Updated: 2026-05-11
Results Overview
Participates developed blood glucose concentration lower than 54 mg/dL
COMPLETED
NA
38 participants
During the first 48 hours after admission
2026-05-11
Participant Flow
Participants were recruited by PI: Hou-Hsien Chiang at University of Washington - Montlake, Harborview and Northwest hospitals from March 2024 to May 2025.
The observational cohort arm was historical 140 participants, and therefore, were not included in the enrollment number.
Participant milestones
| Measure |
Initial Insulin Dosing Calculator
Participants received initial insulin doses by the calculator on hospital admission
|
Observational Cohort
Historical patients who received initial insulin doses by standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
140
|
|
Overall Study
COMPLETED
|
38
|
140
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Initial Insulin Dosing Calculator
n=38 Participants
Participants received initial insulin doses by the calculator on hospital admission
|
Observational Cohort
n=140 Participants
Historical patients who received initial insulin doses by standard of care
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 year
n=38 Participants
|
63.6 year
n=140 Participants
|
63.6 year
n=178 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=38 Participants
|
60 Participants
n=140 Participants
|
74 Participants
n=178 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=38 Participants
|
80 Participants
n=140 Participants
|
104 Participants
n=178 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body weight
|
88.5 kg
n=38 Participants
|
88.3 kg
n=140 Participants
|
88.4 kg
n=178 Participants
|
|
Body mass index
|
28.7 kg/m²
n=38 Participants
|
30.0 kg/m²
n=140 Participants
|
29.7 kg/m²
n=178 Participants
|
|
eGFR
|
50.3 mL/min/1.73m²
n=38 Participants
|
55.9 mL/min/1.73m²
n=140 Participants
|
54.7 mL/min/1.73m²
n=178 Participants
|
|
HbA1c
|
7.8 % HbA1c
n=38 Participants
|
7.7 % HbA1c
n=140 Participants
|
7.7 % HbA1c
n=178 Participants
|
|
Glucocorticoid use
|
3 Participants
n=38 Participants
|
14 Participants
n=140 Participants
|
17 Participants
n=178 Participants
|
|
Home insulin total daily dose
|
36 units/day
n=38 Participants
|
40 units/day
n=140 Participants
|
40 units/day
n=178 Participants
|
|
First blood glucose on presentation
|
207 mg/dL
n=38 Participants
|
198 mg/dL
n=140 Participants
|
200 mg/dL
n=178 Participants
|
PRIMARY outcome
Timeframe: During the first 48 hours after admissionPopulation: All participants received at least the first dose by the calculator before clinicians adjusted their insulin doses
Participates developed blood glucose concentration lower than 54 mg/dL
Outcome measures
| Measure |
Insulin Dosing Calculator
n=38 Participants
Participants received initial insulin doses by the calculator on hospital admission
|
Observational Cohort
n=140 Participants
Historical patients who received initial insulin doses by standard of care
|
|---|---|---|
|
Clinical Significant Hypoglycemia
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During the first 24 hours after admissionPopulation: All participants received at least the first dose by the calculator before clinicians adjusted their insulin doses
Mean of all the point-of-care blood glucose readings during the first 24 hours after admission
Outcome measures
| Measure |
Insulin Dosing Calculator
n=38 Participants
Participants received initial insulin doses by the calculator on hospital admission
|
Observational Cohort
n=140 Participants
Historical patients who received initial insulin doses by standard of care
|
|---|---|---|
|
Mean Blood Glucose Concentration (mg/dL)
|
184.5 mg/dL
Standard Deviation 40.3
|
204.0 mg/dL
Standard Deviation 63.4
|
SECONDARY outcome
Timeframe: During the first 48 hours after admissionParticipates developed blood glucose concentration higher or equal to 300 mg/dL
Outcome measures
| Measure |
Insulin Dosing Calculator
n=38 Participants
Participants received initial insulin doses by the calculator on hospital admission
|
Observational Cohort
n=140 Participants
Historical patients who received initial insulin doses by standard of care
|
|---|---|---|
|
Clinical Significant Hyperglycemia
|
1 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: During the first 48 hours after admissionPopulation: All participants received at least the first dose by the calculator before clinicians adjusted their insulin doses
Participates developed blood glucose concentration lower than 70 mg/dL
Outcome measures
| Measure |
Insulin Dosing Calculator
n=38 Participants
Participants received initial insulin doses by the calculator on hospital admission
|
Observational Cohort
n=140 Participants
Historical patients who received initial insulin doses by standard of care
|
|---|---|---|
|
Hypoglycemia Lower Than 70 mg/dL
|
0 Participants
|
2 Participants
|
Adverse Events
Initial Insulin Dosing Calculator
Observational Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place