Prospective Study of Personalized Approach to Inpatient Patients With Hyperglycemia

NCT03904199 | Completed Early Phase 1 FDA Drug

• 1 other identifier: MCC-19637
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperglycemia

Keywords

High Blood Sugar; High Blood Glucose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of high blood glucose levels

  During hospital admission, up to 30 days

• Proportion of low blood glucose levels

  During hospital admission, up to 30 days

• Duration of normal blood glucose level

  During hospital admission, up to 30 days

Study Arms (2)

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.

Drug: Insulin

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.

Drug: Insulin

Interventions

Insulin DRUG

Participants will receive long-acting insulin and/or rapid-acting insulin per protocol

Also known as: Basal insulin, Prandial insulin

Basal-Prandial-Correctional Insulin Regimen; Standard of Care Insulin Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Hyperglycemia

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Smitha Pabbathi, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 5, 2019
• Study Start: April 4, 2019
• Primary Completion: October 14, 2020
• Study Completion: November 2, 2021
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)