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To determine if co-administration of subcutaneous (SQ)Insulin glargine in combination with intravenous (IV) insulin decreases the time to resolution of ketoacidosis and requirement for ICU admission compared to IV insulin with delayed administration of SQ glargine for the treatment of diabetic ketoacidosis (DKA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Glargine plus Regular Insulin | Experimental | 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. |
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| Control - Regular Insulin | Active Comparator | Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to 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. Results reported are adjusted for initial anion gap, etiology of diabetic ketoacidosis, and comorbidities. | Participants monitored from hospital admission to discharge, an average of 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Admitted to the ICU | 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. | Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pratik B Doshi, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon B Johnson Hospital | Houston | Texas | 77026 | United States | ||
| Memorial Herman Hospital-Texas Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17508198 | Background | Shankar V, Haque A, Churchwell KB, Russell W. Insulin glargine supplementation during early management phase of diabetic ketoacidosis in children. Intensive Care Med. 2007 Jul;33(7):1173-1178. doi: 10.1007/s00134-007-0674-3. Epub 2007 May 17. | |
| 26013711 | Result | Doshi P, Potter AJ, De Los Santos D, Banuelos R, Darger BF, Chathampally Y. Prospective randomized trial of insulin glargine in acute management of diabetic ketoacidosis in the emergency department: a pilot study. Acad Emerg Med. 2015 Jun;22(6):657-62. doi: 10.1111/acem.12673. Epub 2015 May 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Regular Insulin |
| Drug |
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| Intensive Care Unit Length of Stay |
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. |
| Participants monitored from hospital admission to discharge, an average of 4 days |
| Hospital Length of Stay | 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. | Participants monitored from hospital admission to discharge, an average of 4 days |
| Number of Participants Who Developed Hypoglycemia | 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. | Participants monitored during the 24 hours after anion gap closure |
| Houston |
| Texas |
| 77030 |
| United States |
| Control - Regular Insulin |
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring. Regular Insulin |
| COMPLETED |
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| NOT COMPLETED |
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All who were enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control - Regular Insulin | Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring. Regular Insulin |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to 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. Results reported are adjusted for initial anion gap, etiology of diabetic ketoacidosis, and comorbidities. | While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis). | Posted | Mean | Standard Error | hours | Participants monitored from hospital admission to discharge, an average of 4 days |
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| Secondary | Number of Participants Admitted to the ICU | 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. | While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis). | Posted | Number | participants | Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours |
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| ||||||||||||||||||||||||||||||
| Secondary | Intensive Care Unit Length of Stay | 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. | While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis). | Posted | Median | Inter-Quartile Range | days | Participants monitored from hospital admission to discharge, an average of 4 days |
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| Secondary | Hospital Length of Stay | 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. | While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis). | Posted | Mean | Standard Error | days | Participants monitored from hospital admission to discharge, an average of 4 days |
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| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Developed Hypoglycemia | 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. | While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis). | Posted | Number | participants | Participants monitored during the 24 hours after anion gap closure |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 20 | 2 | 20 | ||
| EG001 | Control - Regular Insulin | Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring. Regular Insulin | 0 | 20 | 3 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pratik B. Doshi | The University of Texas Health Science Center at Houston | 713-608-6537 | Pratik.B.Doshi@uth.tmc.edu |
| ID | Term |
|---|---|
| D016883 | Diabetic Ketoacidosis |
| D003920 | Diabetes Mellitus |
| D000138 | Acidosis |
| ID | Term |
|---|---|
| D007662 | Ketosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011384 | Proinsulin |
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| Male |
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