Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| OCAST HR06-13 |
Not provided
Not provided
Not provided
study terminated due to lack of enrollment
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| Name | Class |
|---|---|
| Oklahoma Center for the Advancement of Science and Technology | OTHER |
Not provided
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To determine whether intensive glucose control results in improved mortality and reduced hospital stay length by performing a randomized trial of intensive glucose management (blood glucose goal 110 mg/dl) using continuous IV insulin and glucose vs. non-intensive glucose management (goal 200 mg/dl)
TO determine whether there are fewer infections, days without a fever, days on antibiotics given for an infection and time to marrow engraftment are improved by intensive glucose management; and to determine whether there is evidence of a reduction in measures of inflammation in patients randomized to intensive glucose management and whether reduction of inflammation is associated with outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Regular Sliding Scale Insulin administration for hyperglycemia |
|
| Arm 2 | Experimental | MiniMed Paradigm monitoring device for hyperglycemia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular Insulin | Drug | Use of sliding scale insulin as per Appendix 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT) | 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Infection | About 100 days | |
| Reduced Length of In-hospital Stay | About 100 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Selby, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
Not provided
Recruitment was not satisfactory to study completion; study terminated early.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin |
| FG001 | Arm 2 | Baseline IV Insulin infusion begins with: >220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime Sliding Scale IV Insulin adjustments based on: >201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin |
| BG001 | Arm 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Reduction of Infection | Not Posted | About 100 days | Participants | ||||||||||||
| Secondary | Reduced Length of In-hospital Stay | Not Posted | About 100 days | Participants | ||||||||||||
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin |
Not provided
Not provided
This study was terminated early due to lack of enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Selby, MD | University of Oklahoma Health Sciences Center | 405-271-4022 | george-selby@ouhsc.edu |
Not provided
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Deployment of the MiniMed Paradigm monitoring device |
| Device |
Automated insulin delivery system |
|
Baseline IV Insulin infusion begins with:
>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime
Sliding Scale IV Insulin adjustments based on:
>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary |
| Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT) |
Due to early termination, data not analyzed |
| Posted |
| 100 days |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Arm 2 | Baseline IV Insulin infusion begins with: >220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime Sliding Scale IV Insulin adjustments based on: >201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion | 0 | 5 | 0 | 5 |
Not provided
Not provided
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |