Prospective Study of Personalized Approach to Inpatient Patients With Hyperglycemia

NCT ID: NCT03904199

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-04
• Study Completion Date: 2021-11-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Insulin

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Insulin

Intervention Type: DRUG

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

Interventions

Insulin

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

Intervention Type: DRUG

Other Intervention Names

Basal insulin; Prandial insulin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Smitha Pabbathi, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Moffitt Cancer Center

Tampa, Florida, United States

Countries

United States

Other Identifiers

MCC-19637

Identifier Type: -

Identifier Source: org_study_id