Prospective Study of Personalized Approach to Inpatient Patients With Hyperglycemia

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia
• Intervention / Treatment: Drug: Insulin

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Basal-Prandial-Correctional Insulin Regimen; 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; Participants will receive long-acting insulin and/or rapid-acting insulin per protocol; Other Names: Basal insulin; Prandial insulin
Active Comparator: Standard of Care Insulin Regimen; 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; Participants will receive long-acting insulin and/or rapid-acting insulin per protocol; Other Names: Basal insulin; Prandial insulin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Smitha Pabbathi, MD, Moffitt Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Actual): October 14, 2020
• Study Completion (Actual): November 2, 2021

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: High Blood Sugar; High Blood Glucose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: MCC-19637

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes