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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

During the first 48 hours after admission

Results posted on

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

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

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 admission

Population: 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

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 admission

Population: 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

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 admission

Participates developed blood glucose concentration higher or equal to 300 mg/dL

Outcome measures

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 admission

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Observational Cohort

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinician researcher

University of Washington

Phone: 206-221-5705

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place