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Clinical Trial 19637

Cancer Type: Multiple
Interventions:Insulin

Study Type: Supportive Care
Phase of Study: N/A
Investigators:

  • Smitha Pabbathi

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

Study Title

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

Summary

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.

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 >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