Trial Outcomes & Findings for 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 NCT02006342)
NCT ID: NCT02006342
Last Updated: 2017-05-16
Results Overview
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.
COMPLETED
NA
40 participants
Participants monitored from hospital admission to discharge, an average of 4 days
2017-05-16
Participant Flow
Participant milestones
| Measure |
Insulin Glargine Plus Regular Insulin
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Insulin Glargine
Regular Insulin
|
Control - Regular Insulin
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Regular Insulin
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis
Baseline characteristics by cohort
| Measure |
Insulin Glargine Plus Regular Insulin
n=20 Participants
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Insulin Glargine
Regular Insulin
|
Control - Regular Insulin
n=20 Participants
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Regular Insulin
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.5 years
n=99 Participants
|
41.5 years
n=107 Participants
|
41 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Participants monitored from hospital admission to discharge, an average of 4 daysPopulation: While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).
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.
Outcome measures
| Measure |
Insulin Glargine Plus Regular Insulin
n=20 Participants
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Insulin Glargine
Regular Insulin
|
Control - Regular Insulin
n=20 Participants
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Regular Insulin
|
|---|---|---|
|
Time to Anion Gap Closure
|
10.2 hours
Standard Error 6.8
|
11.6 hours
Standard Error 6.4
|
SECONDARY outcome
Timeframe: Participants followed for the duration of the Emergency Department stay, an expected average of 12 hoursPopulation: While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).
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.
Outcome measures
| Measure |
Insulin Glargine Plus Regular Insulin
n=20 Participants
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Insulin Glargine
Regular Insulin
|
Control - Regular Insulin
n=20 Participants
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Regular Insulin
|
|---|---|---|
|
Number of Participants Admitted to the ICU
|
6 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Participants monitored from hospital admission to discharge, an average of 4 daysPopulation: While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).
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.
Outcome measures
| Measure |
Insulin Glargine Plus Regular Insulin
n=20 Participants
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Insulin Glargine
Regular Insulin
|
Control - Regular Insulin
n=20 Participants
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Regular Insulin
|
|---|---|---|
|
Intensive Care Unit Length of Stay
|
1.8 days
Interval 1.6 to 1.9
|
1.2 days
Interval 0.8 to 1.8
|
SECONDARY outcome
Timeframe: Participants monitored from hospital admission to discharge, an average of 4 daysPopulation: While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).
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.
Outcome measures
| Measure |
Insulin Glargine Plus Regular Insulin
n=20 Participants
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Insulin Glargine
Regular Insulin
|
Control - Regular Insulin
n=20 Participants
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Regular Insulin
|
|---|---|---|
|
Hospital Length of Stay
|
3.9 days
Standard Error 3.4
|
4.6 days
Standard Error 3.6
|
SECONDARY outcome
Timeframe: Participants monitored during the 24 hours after anion gap closurePopulation: While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).
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.
Outcome measures
| Measure |
Insulin Glargine Plus Regular Insulin
n=20 Participants
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Insulin Glargine
Regular Insulin
|
Control - Regular Insulin
n=20 Participants
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Regular Insulin
|
|---|---|---|
|
Number of Participants Who Developed Hypoglycemia
|
2 participants
|
3 participants
|
Adverse Events
Insulin Glargine Plus Regular Insulin
Control - Regular Insulin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Insulin Glargine Plus Regular Insulin
n=20 participants at risk
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Insulin Glargine
Regular Insulin
|
Control - Regular Insulin
n=20 participants at risk
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Regular Insulin
|
|---|---|---|
|
Metabolism and nutrition disorders
hypoglycemia
|
10.0%
2/20 • Number of events 2 • 24 hours after anion gap closure
Participants were systematically assessed for hypoglycemia. 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.
|
15.0%
3/20 • Number of events 3 • 24 hours after anion gap closure
Participants were systematically assessed for hypoglycemia. 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.
|
Additional Information
Dr. Pratik B. Doshi
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place