Hyperglycemia
Conditions
Keywords
High Blood Sugar, High Blood Glucose
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.
Interventions
DRUGInsulin
Participants will receive long-acting insulin and/or rapid-acting insulin per protocol
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of blood glucose values within normal range | During hospital admission, up to 30 days | Proportion of blood glucose values in the 70 mg/dL to 180 mg/dL (normal) range |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of high blood glucose levels | During hospital admission, up to 30 days | Proportion of blood glucose values \>180 mg/dL |
| Proportion of low blood glucose levels | During hospital admission, up to 30 days | Proportion of blood glucose values \<70 mg/dL |
| Duration of normal blood glucose level | During hospital admission, up to 30 days | Duration of blood glucose values in the 70 mg/dL to 180 mg/dL (normal) range |
Countries
United States
Outcome results
None listed