Prospective Study of Personalized Approach to Inpatient Patients With Hyperglycemia

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03904199
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperglycemia	Drug: Insulin	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Prospective Randomized Study of a Personalized Approach to the Inpatient Management of Hospitalized Oncology Patients With Hyperglycemia
• Actual Study Start Date: Apr 4, 2019
• Actual Primary Completion Date: Oct 14, 2020
• Anticipated Study Completion Date: Apr 3, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of blood glucose values within normal range [During hospital admission, up to 30 days]

   Proportion of blood glucose values in the 70 mg/dL to 180 mg/dL (normal) range

Secondary Outcome Measures

1. Proportion of high blood glucose levels [During hospital admission, up to 30 days]

   Proportion of blood glucose values >180 mg/dL

2. Proportion of low blood glucose levels [During hospital admission, up to 30 days]

   Proportion of blood glucose values <70 mg/dL

3. Duration of normal blood glucose level [During hospital admission, up to 30 days]

   Duration of blood glucose values in the 70 mg/dL to 180 mg/dL (normal) range

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moffitt Cancer Center	Tampa	Florida	United States	33612

Sponsors and Collaborators

• H. Lee Moffitt Cancer Center and Research Institute

Investigators

• Principal Investigator: Smitha Pabbathi, MD, Moffitt Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• ClinicalTrials.gov Identifier: NCT03904199
• Other Study ID Numbers: MCC-19637
• First Posted: Apr 5, 2019
• Last Update Posted: Aug 17, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by H. Lee Moffitt Cancer Center and Research Institute: High Blood Sugar; High Blood Glucose
• Additional relevant MeSH terms: Hyperglycemia; Insulin; Insulin, Globin Zinc

Study Results

No Results Posted as of Aug 17, 2022