Trial · NCT02006342
Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis
NCT02006342, Not applicable, Completed, The University of Texas Health Science Center, Houston; results first posted 2017-05-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis. Trials, record NCT02006342. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02006342
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis
- NCT number
- NCT02006342
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 40 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Diabetic Ketoacidosis
- Interventions
- Insulin Glargine, Regular Insulin
- First posted
- 2013-12-10
- Last updated
- 2017-05-16
- Results first posted
- 2017-05-16
- Limitations and caveats
- The study had a limited sample size; therefore, the results cannot definitively answer the research question. Also, because a convenience sample was used, there might be selection bias.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Anion Gap Closure | Participants monitored from hospital admission to discharge, an average of 4 days | Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production. Results reported are adjusted for initial anion gap, etiology of diabetic ketoacidosis, and comorbidities. |
| Secondary | Number of Participants Admitted to the ICU | Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours | The goal was to determine if the amount of patients admitted to the ICU could be reduced by providing more efficient resolution of the critical condition which is the acidosis. |
| Secondary | Intensive Care Unit Length of Stay | Participants monitored from hospital admission to discharge, an average of 4 days | Determine the amount of time patient is admitted to the intensive care unit with the goal of assessing if more efficient correction of the acidosis results in decreased time in the intensive care unit for the patients. |
| Secondary | Hospital Length of Stay | Participants monitored from hospital admission to discharge, an average of 4 days | Hospital length of stay was determined to assess whether a more efficient correction of the acidosis will result in decreased time that the patient is admitted to the hospital. Results reported are adjusted for age, hospital site, and etiology of diabetic ketoacidosis. |
| Secondary | Number of Participants Who Developed Hypoglycemia | Participants monitored during the 24 hours after anion gap closure | To determine whether it is safe to administer both IV and subcutaneous insulin, it is important to assure that patient's glucose does not drop to critically low level and lead to adverse events. Hypoglycemia was defined as less than or equal to 60mg/dL during 24 hours after anion gap closure. Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Anion Gap Closure | Participants monitored from hospital admission to discharge, an average of 4 days | While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis). | hours | MEAN |
| SECONDARY | Number of Participants Admitted to the ICU | Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours | While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis). | participants | NUMBER |
| SECONDARY | Intensive Care Unit Length of Stay | Participants monitored from hospital admission to discharge, an average of 4 days | While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis). | days | MEDIAN |
| SECONDARY | Hospital Length of Stay | Participants monitored from hospital admission to discharge, an average of 4 days | While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis). | days | MEAN |
| SECONDARY | Number of Participants Who Developed Hypoglycemia | Participants monitored during the 24 hours after anion gap closure | While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Anion Gap Closure | Insulin Glargine Plus Regular Insulin | 10.2 | Standard Error 6.8 | hours | |
| Time to Anion Gap Closure | Control - Regular Insulin | 11.6 | Standard Error 6.4 | hours | |
| Number of Participants Admitted to the ICU | Insulin Glargine Plus Regular Insulin | 6 | participants | ||
| Number of Participants Admitted to the ICU | Control - Regular Insulin | 4 | participants | ||
| Intensive Care Unit Length of Stay | Insulin Glargine Plus Regular Insulin | 1.8 | Inter-Quartile Range 1.6 to 1.9 | days | |
| Intensive Care Unit Length of Stay | Control - Regular Insulin | 1.2 | Inter-Quartile Range 0.8 to 1.8 | days | |
| Hospital Length of Stay | Insulin Glargine Plus Regular Insulin | 3.9 | Standard Error 3.4 | days | |
| Hospital Length of Stay | Control - Regular Insulin | 4.6 | Standard Error 3.6 | days | |
| Number of Participants Who Developed Hypoglycemia | Insulin Glargine Plus Regular Insulin | 2 | participants | ||
| Number of Participants Who Developed Hypoglycemia | Control - Regular Insulin | 3 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Insulin Glargine Plus Regular Insulin | 20 | |
| Overall Study | STARTED | Control - Regular Insulin | 20 | |
| Overall Study | COMPLETED | Insulin Glargine Plus Regular Insulin | 19 | |
| Overall Study | COMPLETED | Control - Regular Insulin | 20 | |
| Overall Study | NOT COMPLETED | Insulin Glargine Plus Regular Insulin | 1 | |
| Overall Study | NOT COMPLETED | Control - Regular Insulin | 0 |
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 | Metabolism and nutrition disorders | Insulin Glargine Plus Regular Insulin | 2 | 20 | 2 |
| other | hypoglycemia | Metabolism and nutrition disorders | Control - Regular Insulin | 3 | 20 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Insulin Glargine Plus Regular Insulin | ||
| Total, all-cause mortality | Control - Regular Insulin | ||
| Total, other adverse events | Insulin Glargine Plus Regular Insulin | 2 | 20 |
| Total, other adverse events | Control - Regular Insulin | 3 | 20 |
| Total, serious adverse events | Insulin Glargine Plus Regular Insulin | 0 | 20 |
| Total, serious adverse events | Control - Regular Insulin | 0 | 20 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Insulin Glargine Plus Regular Insulin vs Control - Regular Insulin: Number of Participants Who Developed Hypoglycemia | Trial comparisons |
| Insulin Glargine Plus Regular Insulin vs Control - Regular Insulin: Number of Participants Admitted to the ICU | Trial comparisons |
| Insulin Glargine Plus Regular Insulin vs Control - Regular Insulin: 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/NCT02006342
GET https://conductscience.org/api/trials/v1/NCT02006342/registered