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OpenTrials
Completed

NCT Number: NCT03904199

Prospective Study of Personalized Approach to Inpatient Patients With Hyperglycemia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin

Drug

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

Other names: Basal insulin, Prandial insulin

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 5, 2019
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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