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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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The purpose of this study is to determine whether insulin administered by a subcutaneous injection is effective in the treatment of a diabetic crisis and to determine if beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous Insulin | Active Comparator | Aspart Insulin administered subcutaneously 0.2 units/kg/sq every 2 hours |
|
| IV Regular Insulin | Active Comparator | Intravenous Regular Insulin 0.1 units/kg/hour |
|
| Intravenous Novolog Insulin | Active Comparator | Intravenous Novolog Insulin 0.1 units/kg/hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin (Aspart Insulin [Novolog], Regular Insulin) | Drug | Aspart Insulin 0.2units/sq q 2 hours Regular Insulin 0.1units/kg/hr intravenous Aspart Insulin 0.1 units/kg/hr intravenous |
| Measure | Description | Time Frame |
|---|---|---|
| Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6 | q 2 hours | |
| Hours to achieve blood glucose less than 200mg/dl | q 1 hour |
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Inclusion Criteria: age 18 or older
venous pH < 7.3 or arterial < 7.35
at least 2 of the following 3:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rema A Gupta, MD | Rush University Medical Center | Principal Investigator |
| David Baldwin, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D016883 | Diabetic Ketoacidosis |
| ID | Term |
|---|---|
| D007662 | Ketosis |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |