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Prospective Study of Personalized Approach to Inpatient Patients With Hyperglycemia

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ClinicalTrials.gov Identifier: NCT03904199
Recruitment Status : Active, not recruiting
First Posted : April 5, 2019
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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

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Study Type : Interventional  (Clinical Trial)
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 : April 4, 2019
Actual Primary Completion Date : October 14, 2020
Estimated Study Completion Date : April 3, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Proportion of blood glucose values within normal range [ Time Frame: 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 [ Time Frame: During hospital admission, up to 30 days ]
    Proportion of blood glucose values >180 mg/dL

  2. Proportion of low blood glucose levels [ Time Frame: During hospital admission, up to 30 days ]
    Proportion of blood glucose values <70 mg/dL

  3. Duration of normal blood glucose level [ Time Frame: During hospital admission, up to 30 days ]
    Duration of blood glucose values in the 70 mg/dL to 180 mg/dL (normal) range



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904199


Locations
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United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Principal Investigator: Smitha Pabbathi, MD Moffitt Cancer Center
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT03904199    
Other Study ID Numbers: MCC-19637
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs