Continuous Glucose Monitoring of Hospitalized Patients With Diabetes
Diabetes, Diabetes Mellitus, Glucose, High Blood
About this trial
This is an interventional diagnostic trial for Diabetes focused on measuring diabetes
Eligibility Criteria
Inclusion Criteria:
- Patients with Type 1 and Type 2 diabetes.
- Subjects 18 years of age or older with diabetes.
- Subjects willing to avoid using high dose acetaminophen (defined as greater than 4 gm per day)
- Subjects with expected hospital length-of-stay of 2 or more days.
- Subjects willing to wear CGM device.
Exclusion Criteria:
- Female subjects who are pregnant or lactating at the time of enrollment into the study. Females with childbearing potential will be queried about the possibility of pregnancy and a serum pregnancy test will be performed.
- Subjects with greater than 4gm use of Tylenol/24 hr.
- Surgical patients or patients with pre-planned surgery during the study.
- Subjects with acute illness admitted to the ICU or expected to require admission to the ICU.
- Patients who may potentially require IV insulin.
- Patients with skin lesions, severe psoriasis, burns, tattoos, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
- Patient with a known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Patients who have had organ transplant.
- Hematocrit outside specification of the study-assigned blood glucose meter (hematocrit ≤ 30% or ≥ 55%).
- Patients with any severe medical conditions such as end-stage renal disease on dialysis, status post renal transplantation, end-stage liver disease with diffuse anasarca, heart failure on inotropic support, Ejection Fraction (EF) < 15 % or pulmonary disease requiring Non-Invasive Positive Pressure Ventilation (NIPPV) or severe sepsis.
- Any condition for which, in the opinion of the investigators, it would not be in the best interest of the participant.
- Legally protected subjects (under judicial protection, guardianship, or supervision), persons deprived of their liberty, mental or language barriers rendering the subject unable to understand the nature, scope and possible consequences of the study.
- Subjects with active substance abuse.
- Subjects with infaust prognosis.
Sites / Locations
- Baylor Scott & White Medical Center - Temple
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Control Group
Treatment Group
Control Group subjects will wear the CGM device during their hospitalization, up to 10 days, but glucose readings will NOT be continuously monitored. Control Group subjects will have their glucose management guided by routine standard of care finger sticks. The readings from the CGM device are recorded and reviewed retrospectively, but not used for glucose management during the hospital stay.
Treatment Group subjects will wear the CGM device during their hospitalization, up to 10 days, and glucose readings WILL be continuously monitored. Treatment Group subjects will have their glucose management guided by readings from the CGM device and standard of care finger sticks.