Continuous Glucose Monitoring of Hospitalized Patients With Diabetes

Phase

N/A

Condition

Diabetic Kidney Disease

Diabetic Neuropathy

Diabetic Macular Edema

Treatment

Dexcom Generation 6 CGM (Dexcom Gen6) device

Clinical Study ID

NCT04230694

018-601

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 4gm per day)
Subjects with expected hospital length-of-stay of 2 or more days beyond the time ofenrollment.
Subjects willing to wear CGM device.

Exclusion

Exclusion Criteria:

Female subjects who are pregnant or lactating at the time of enrollment into thestudy. Females with childbearing potential will be queried about the possibility ofpregnancy 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 48hours.
Subjects with acute illness admitted to the ICU or expected to require admission tothe 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 deviceplacement or the accuracy of interstitial glucose measurements.
Patient with a known allergy to medical grade adhesive or isopropyl alcohol used todisinfect skin.
Patients who have had organ transplant.
Patients with any severe medical conditions such as end-stage renal disease ondialysis, status post renal transplantation, end-stage liver disease with diffuseanasarca, heart failure on inotropic support, Ejection Fraction (EF) < 15 % orsevere sepsis.
Any condition for which, in the opinion of the investigators, it would not be in thebest interest of the participant.
Legally protected subjects (under judicial protection, guardianship, orsupervision), persons deprived of their liberty, mental or language barriersrendering the subject unable to understand the nature, scope and possibleconsequences of the study.
Subjects with active substance abuse.
Subjects with infaust prognosis.

Study Design

Dexcom Generation 6 CGM (Dexcom Gen6) device

September 20, 2021

December 31, 2024

Study Description

AIM

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).

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.
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.

Connect with a study center

Baylor Scott & White Medical Center - Temple
Temple, Texas 76508
United States
Site Not Available

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