Clinical trial NCT03904199: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hyperglycemia
Keywords: High Blood Sugar
High Blood Glucose
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Proportion of blood glucose values within normal range
timeFrame: During hospital admission, up to 30 days
Secondary outcomes:
measure: Proportion of high blood glucose levels
timeFrame: During hospital admission, up to 30 days
measure: Proportion of low blood glucose levels
timeFrame: During hospital admission, up to 30 days
measure: Duration of normal blood glucose level
timeFrame: During hospital admission, up to 30 days
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Smitha Pabbathi, MD
role: PRINCIPAL_INVESTIGATOR
References: