Trial · NCT01101867
Prandial Insulin Dosing in Hospitalized Patients
NCT01101867, Phase 4, Completed, Kathleen Dungan; results first posted 2013-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prandial Insulin Dosing in Hospitalized Patients. Trials, record NCT01101867. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01101867
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prandial Insulin Dosing in Hospitalized Patients
- NCT number
- NCT01101867
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 126 participants, actual
- Lead sponsor
- Kathleen Dungan
- Conditions
- Diabetes, Admitting Hospital, Non-critically Ill
- Interventions
- Aspart fixed dose, Aspart flexible dose
- First posted
- 2010-04-12
- Last updated
- 2018-01-31
- Results first posted
- 2013-07-02
- Limitations and caveats
- Miscalculation of meal doses, mistimed doses, lack of complete documentation of carbohydrate intake, and dosing conducted by an experienced clinician may have contributed to the findings.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Glucose | day 3 | Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3 |
| Secondary | Postprandial Glucose | day 3 | Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3. |
| Secondary | Hypoglycemia | 72 hour | Number of patients with any hypoglycemic event (\<70 mg/dl or \<40 mg/dl) |
| Secondary | Change in Glucose | 72 hour | Change in mean glucose from day 1 to day 3, measured as difference in mean glucose day 3 minus mean glucose day 1. |
| Secondary | Treatment Satisfaction | day 3 | treatment satisfaction questionnaire validated in-hospital, 19 item questionnaire using 0-6 point likert scale, for minimum zero to maximum of 102 points (with 102 indicating best satisfaction). Items are summed to find the total score. |
| Secondary | 1,5-anhydroglucitol Change | day 1 to day 3 | change in short-term measure of glycemia |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Glucose | day 3 | Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status. | mg/dl | MEAN |
| SECONDARY | Postprandial Glucose | day 3 | Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status. | mg/dl | MEAN |
| SECONDARY | Hypoglycemia | 72 hour | participants | NUMBER | |
| SECONDARY | Change in Glucose | 72 hour | intention to treat population | mg/dl | MEAN |
| SECONDARY | Treatment Satisfaction | day 3 | all participants who completed the survey | points on a scale | MEAN |
| SECONDARY | 1,5-anhydroglucitol Change | day 1 to day 3 | subjects with complete data | mcg/ml | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Glucose | Flexible Dose | 158 | Standard Deviation 47 | mg/dl | |
| Mean Glucose | Fixed Dose | 171 | Standard Deviation 49 | mg/dl | |
| Postprandial Glucose | Flexible Dose | 175 | Standard Deviation 51 | mg/dl | |
| Postprandial Glucose | Fixed Dose | 203 | Standard Deviation 74 | mg/dl | |
| Hypoglycemia | Flexible Dose | 24 | participants | ||
| Hypoglycemia | Fixed Dose | 14 | participants | ||
| Change in Glucose | Aspart Flexible Dose | -4.2 | Standard Deviation 35 | mg/dl | |
| Change in Glucose | Aspart Fixed Dose | -8.1 | Standard Deviation 54 | mg/dl | |
| Treatment Satisfaction | Flexible Dose | 69 | Standard Deviation 14 | points on a scale | |
| Treatment Satisfaction | Fixed Dose | 68 | Standard Deviation 13 | points on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Flexible Dose | 63 | |
| Overall Study | STARTED | Fixed Dose | 63 | |
| Overall Study | COMPLETED | Flexible Dose | 62 | |
| Overall Study | COMPLETED | Fixed Dose | 59 | |
| Overall Study | NOT COMPLETED | Flexible Dose | 1 | |
| Overall Study | NOT COMPLETED | Fixed Dose | 4 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypoglycemia (BG <70 mg/dl) | Endocrine disorders | Flexible Dose | 24 | 62 | |
| other | Hypoglycemia (BG <70 mg/dl) | Endocrine disorders | Fixed Dose | 14 | 59 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Flexible Dose | ||
| Total, all-cause mortality | Fixed Dose | ||
| Total, other adverse events | Flexible Dose | 24 | 62 |
| Total, other adverse events | Fixed Dose | 14 | 59 |
| Total, serious adverse events | Flexible Dose | 0 | 62 |
| Total, serious adverse events | Fixed Dose | 0 | 59 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Flexible Dose vs Fixed Dose: Hypoglycemia | Trial comparisons |
| Flexible Dose vs Fixed Dose: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01101867
GET https://conductscience.org/api/trials/v1/NCT01101867/registered