Continuous Glucose Monitoring of Hospitalized Patients With Diabetes (NCT04230694) | Clinical Trial Compass
CompletedNot Applicable
Continuous Glucose Monitoring of Hospitalized Patients With Diabetes
United States40 participantsStarted 2021-09-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Hypoglycemia Events during hospitalization