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Clinical Trial 19637

Cancer Type: Multiple
Study Type: Supportive Care
NCT#: NCT03904199

Phase: N/A
Prinicipal Investigator: Smitha Pabbathi

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

A Prospective Single-Arm Feasibility Study of a Personalized Approach to the Inpatient Management of Hospitalized Oncology Patients with Hyperglycemia

Summary

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.

Objective

Primary Objective: To correctly implement the basal-prandial-correctional insulin protocol in hospitalized oncology patients in medical units, in order to achieve euglycemia. Important Secondary Objectives: To demonstrate that the correct implementation of basal-prandial-correctional insulin in hospitalized Hispanic patients will reduce the disparity between outcomes for Hispanic and non-Hispanic patients, thereby closing a cancer health disparity gap.

Treatments

Therapies

Medications

Insulin ()

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 48 hours of hospitalization, 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 > Patients of non-Hispanic descent
  • Participants at the end of life and/or with limited life expectancies (>Participants without cancer diagnoses
  • Surgical participants and participants 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

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.