search
Back to results

Prospective Study of Personalized Approach to Inpatient Patients With Hyperglycemia

Primary Purpose

Hyperglycemia

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Insulin
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hyperglycemia focused on measuring High Blood Sugar, High Blood Glucose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Moffitt Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Basal-Prandial-Correctional Insulin Regimen

Standard of Care Insulin Regimen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of high blood glucose levels
Proportion of blood glucose values >180 mg/dL
Proportion of low blood glucose levels
Proportion of blood glucose values <70 mg/dL
Duration of normal blood glucose level
Duration of blood glucose values in the 70 mg/dL to 180 mg/dL (normal) range

Full Information

First Posted
April 3, 2019
Last Updated
January 19, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03904199
Brief Title
Prospective Study of Personalized Approach to Inpatient Patients With Hyperglycemia
Official Title
A Prospective Randomized Study of a Personalized Approach to the Inpatient Management of Hospitalized Oncology Patients With Hyperglycemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 4, 2019 (Actual)
Primary Completion Date
October 14, 2020 (Actual)
Study Completion Date
November 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
High Blood Sugar, High Blood Glucose

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Basal-Prandial-Correctional Insulin Regimen
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care Insulin Regimen
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
Basal insulin, Prandial insulin
Intervention Description
Participants will receive long-acting insulin and/or rapid-acting insulin per protocol
Primary Outcome Measure Information:
Title
Proportion of blood glucose values within normal range
Description
Proportion of blood glucose values in the 70 mg/dL to 180 mg/dL (normal) range
Time Frame
During hospital admission, up to 30 days
Secondary Outcome Measure Information:
Title
Proportion of high blood glucose levels
Description
Proportion of blood glucose values >180 mg/dL
Time Frame
During hospital admission, up to 30 days
Title
Proportion of low blood glucose levels
Description
Proportion of blood glucose values <70 mg/dL
Time Frame
During hospital admission, up to 30 days
Title
Duration of normal blood glucose level
Description
Duration of blood glucose values in the 70 mg/dL to 180 mg/dL (normal) range
Time Frame
During hospital admission, up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Smitha Pabbathi, MD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prospective Study of Personalized Approach to Inpatient Patients With Hyperglycemia

We'll reach out to this number within 24 hrs