Prospective Study of Personalized Approach to Inpatient Patients With Hyperglycemia

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomized Study of a Personalized Approach to the Inpatient Management of Hospitalized Oncology Patients With Hyperglycemia

Conditions
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Hyperglycemia

Intervention / Treatment
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* Drug: Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Provide race and ethnicity information Male or female, aged 18 years or greater Diagnosed with cancer Hospitalized at MCC in the medical, hematologic, or bone marrow transplant units Having in-hospital hyperglycemia with or without a pre-existing diagnosis of DM, with 2 measurements of BG > 180 mg/dL and/or 1 measurement of BG > 350mg/dL within the first 72 hours of admission, detected by bedside point-of-care testing and/or basic metabolic panel laboratory data. Participants enrolled in other clinical trials are admissible to this trial. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: Participants < 18 years of age Participants at the end of life and/or with limited life expectancies (< 6 months) Participants without cancer diagnoses Surgical patients and patients admitted directly to the intensive care unit, other than those in the Bone Marrow Transplant Unit, who are included Participants treated and discharged in outpatient settings (ie, direct referral center, infusion center, or clinical research unit) or those admitted for observation only (hospitalized less than 24 hours) Participants on total parenteral nutrition Participants on insulin pumps Participants admitted with diabetic ketoacidosis and hyperglycemic hyperosmolar syndrome Pregnant Participants based on medical history Participants being followed by endocrinology for hyperglycemia or hypoglycemia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Basal-Prandial-Correctional Insulin Regimen<br>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. | Drug: Insulin<br>* Participants will receive long-acting insulin and/or rapid-acting insulin per protocol<br>* Other names: Prandial insulin;|
| Active Comparator: Standard of Care Insulin Regimen<br>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. | Drug: Insulin<br>* Participants will receive long-acting insulin and/or rapid-acting insulin per protocol<br>* Other names: Prandial insulin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Blood Sugar, High Blood Glucose