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The purpose of this study is to compare the outcomes between hospitalized cancer patients with high blood sugar receiving the current standard of care of administering insulin, and hospitalized cancer patients receiving a new, individualized method of insulin administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basal-Prandial-Correctional Insulin Regimen | Experimental | Participants hospitalized in the medical, hematologic, or bone marrow transplant units will begin with basal long-acting insulin glargine with correctional and prandial rapid-acting insulin that is personalized and precise, to achieve target blood glucose levels with daily assessments during hospitalization. Adjustments will be made in real time to reach the target range. |
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| Standard of Care Insulin Regimen | Active Comparator | Participants hospitalized in the medical, hematologic, or bone marrow transplant units' blood sugar levels will be managed with sliding scale insulin or a combination of long- and short-acting insulin as per standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | Participants will receive long-acting insulin and/or rapid-acting insulin per protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of blood glucose values within normal range | Proportion of blood glucose values in the 70 mg/dL to 180 mg/dL (normal) range | During hospital admission, up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of high blood glucose levels | Proportion of blood glucose values >180 mg/dL | During hospital admission, up to 30 days |
| Proportion of low blood glucose levels | Proportion of blood glucose values <70 mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Smitha Pabbathi, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| During hospital admission, up to 30 days |
| Duration of normal blood glucose level | Duration of blood glucose values in the 70 mg/dL to 180 mg/dL (normal) range | During hospital admission, up to 30 days |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |