Continuous Glucose Monitoring of Hospitalized Patients With Diabetes

Completed · Not applicable

Conditions studied: Diabetes, Diabetes Mellitus, Glucose, High Blood, Glucose, Low Blood

In brief

Systematic continuous glucose monitoring (CGM) is commonly provided as a treatment option to patients with diabetes in ambulatory care settings yet is rarely provided during hospitalization. CGM of inpatients has the potential to be the care delivery innovation that is feasible, cost effective and can improve glucose control, especially by reducing hypoglycemic events. Studies of CGM use in the ICU setting have been found to be helpful for reducing hypoglycemia in some studies while less so in others, however, these studies were performed with earlier generation glucose monitoring devices(5). ICU studies have confirmed accuracy of CGM measurements compared with capillary glucose even in settings with use of vasopressors and large-volume resuscitation. A limited number of studies have evaluated glycemic outcomes in the inpatient non-ICU setting. Studies of non-ICU patients (6-10) are limited by very small sample size, short study duration, and use of older CGM devices. There is, therefore, a critical need to systematically investigate the use of CGM in the inpatient care of patients with diabetes mellitus who are receiving care in a hospital setting that is typical of inpatient care.

Key facts

Study ID

NCT04230694

Run by

Baylor Research Institute

People needed

40

Starts

2021-09-20

Expected to finish

2024-12-31

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 beyond the time of enrollment.
• Subjects willing to wear CGM device.

You may not qualify if…

• 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 or procedure in the next 48 hours.
• 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.
• 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 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.

Where it is running

• Baylor Scott & White Medical Center - Temple — Temple, Texas, United States

Full record on ClinicalTrials.gov

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