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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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The investigators anticipate that the use of Detemir will decrease the duration of an insulin drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care unit) length of stay, improve glycemic control, and prevent rebound hyperglycemias when the insulin drip is discontinued.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard insulin drip therapy | No Intervention | ||
| Insulin drip and Detemir | Active Comparator | Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Detemir | Drug | Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl) | Number of participants exhibiting rebound hyperglycemia (blood glucose levels over 180 mg/dl) | within 48 hours of discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Duration of Insulin Drip Therapy and Reduction in Total and Average Per Hour Insulin Drip Dose | within one week of insulin drip therapy | |
| Reduction in ICU Length of Stay | within two weeks of hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris Draznin, MD., Ph.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Insulin Drip Therapy | Continuous IV insulin infusion without added detemir |
| FG001 | Insulin Drip and Detemir | Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Insulin Drip Therapy | Continuous IV insulin infusion without added detemir |
| BG001 | Insulin Drip and Detemir | Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl) | Number of participants exhibiting rebound hyperglycemia (blood glucose levels over 180 mg/dl) | Posted | Count of Participants | Participants | within 48 hours of discontinuation |
|
1 Week
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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 | Standard Insulin Drip Therapy | Continuous IV insulin infusion without added detemir |
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We have no information regarding whether many of the outcome measure were collected or analyzed. The PI has retired, and CU Clinical Research Administration has contacted the study team and PI on numerous occasions to try and obtain the data, but have not been able to do so. Therefore, several outcome measures cannot be reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Administration | University of Colorado Denver | 3037241111 | clinicalresearchsupportcenter@ucdenver.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Equal or Improved Diabetes Control | within two weeks of hospitalization |
| Reduction in Time to Get Back to Control of Glycemia (140-180 mg/dl) if Rebound Hyperglycemia Occurs | within one week post insulin drip |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Reduction in Duration of Insulin Drip Therapy and Reduction in Total and Average Per Hour Insulin Drip Dose | We have no information regarding whether this outcome measure was collected or analyzed. The PI has retired, and CU Clinical Research Administration has contacted the study team and PI on numerous occasions to try and obtain the data, but have not been able to do so. Therefore, this outcome measure cannot be reported. | Posted | within one week of insulin drip therapy |
|
|
| Secondary | Reduction in ICU Length of Stay | We have no information regarding whether this outcome measure was collected or analyzed. The PI has retired, and CU Clinical Research Administration has contacted the study team and PI on numerous occasions to try and obtain the data, but have not been able to do so. Therefore, this outcome measure cannot be reported. | Posted | within two weeks of hospitalization |
|
|
| Secondary | Equal or Improved Diabetes Control | We have no information regarding whether this outcome measure was collected or analyzed. The PI has retired, and CU Clinical Research Administration has contacted the study team and PI on numerous occasions to try and obtain the data, but have not been able to do so. Therefore, this outcome measure cannot be reported. | Posted | within two weeks of hospitalization |
|
|
| Secondary | Reduction in Time to Get Back to Control of Glycemia (140-180 mg/dl) if Rebound Hyperglycemia Occurs | We have no information regarding whether this outcome measure was collected or analyzed. The PI has retired, and CU Clinical Research Administration has contacted the study team and PI on numerous occasions to try and obtain the data, but have not been able to do so. Therefore, this outcome measure cannot be reported. | Posted | within one week post insulin drip |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Insulin Drip and Detemir | Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy | 0 | 16 | 0 | 16 | 0 | 16 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |