Clinical trial NCT04230694: Continuous Glucose Monitoring of Hospitalized Patients With Diabetes
Official title: Continuous Glucose Monitoring of Hospitalized Patients With Diabetes: A Pilot Study to Establish Evidence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes
Diabetes Mellitus
Glucose, High Blood
Glucose, Low Blood
Keywords: diabetes
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dexcom Generation 6 CGM (Dexcom Gen6) device
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: AIM

1) Test the health impact of CGM of inpatients as defined by rates of hypo- and hyperglycemia and the derivative of time in appropriate glucose range. Forty (40) patients will be randomized 1:1 into one of two conditions. In the treatment condition, patients will receive a Dexcom Gen6 device and the clinical staff (i.e., nursing and medical staff assigned to the patient's care) will be trained to use readings from the Dexcom Gen6 for the management of the patient's glucose levels below 100. In the control condition, patients will receive a Dexcom Gen6 device, but the clinical staff (i.e., nursing and medical staff assigned to the patient's care) will not have access to the readings and will provide usual care (four glucose checks per 24 hours and use of insulin or other diabetic agent ordered by the admitting and rounding providers to determine glucose management).

1. Hypothesis 1: Patients in the treatment condition will experience fewer episodes of hypoglycemia as compared to patients in the control condition as measured by the Dexcom Gen6 readings.
2. Hypothesis 2: Patients in the treatment condition will experience less frequent hyperglycemia events as compared to patients in the control condition as measured by the Dexcom Gen6 readings.

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 beyond the time of enrollment.
* 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 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.

Primary outcomes:
measure: Number of Hypoglycemia Events during hospitalization
timeFrame: Up to 10 days
Secondary outcomes:
measure: Number of Hyperglycemia Events during hospitalization
timeFrame: Up to 10 days
Other outcomes:
Locations:
city: Temple
country: United States
facility: Baylor Scott & White Medical Center - Temple
state: Texas
Study officials:
affiliation: Baylor Scott & White Medical Center - Temple
name: Tresa McNeal, MD
role: PRINCIPAL_INVESTIGATOR
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