Prospective Study of Personalized Approach to Inpatient Patients With Hyperglycemia

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03904199
• Other study ID #: MCC-19637
• Status: Completed
• Phase: Early Phase 1
• Start date: April 4, 2019
• Est. completion date: November 2, 2021

Study information

• Verified date: January 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2, 2021
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

Drug:
• Insulin
Participants will receive long-acting insulin and/or rapid-acting insulin per protocol

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of high blood glucose levels	Proportion of blood glucose values >180 mg/dL	During hospital admission, up to 30 days
Secondary	Proportion of low blood glucose levels	Proportion of blood glucose values <70 mg/dL	During hospital admission, up to 30 days
Secondary	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