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Clinical Trial NCT04230694 for Diabetes, Diabetes Mellitus, Glucose, High Blood, Glucose, Low Blood is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Continuous Glucose Monitoring of Hospitalized Patients With Diabetes 40
Clinical Trial NCT04230694 is an interventional study for Diabetes, Diabetes Mellitus, Glucose, High Blood, Glucose, Low Blood that is active, not recruiting. It started on 20 September 2021 with plans to enroll 40 participants. Led by Baylor Research Institute, it is expected to complete by 31 December 2024. The latest data from ClinicalTrials.gov was last updated on 3 December 2024.
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 ...Show More
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 f...
Show MoreOfficial Title
Continuous Glucose Monitoring of Hospitalized Patients With Diabetes: A Pilot Study to Establish Evidence
Conditions
DiabetesDiabetes MellitusGlucose, High BloodGlucose, Low BloodPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 018-601
NCT ID Number
Start Date (Actual)
2021-09-20
Last Update Posted
2024-12-03
Completion Date (Estimated)
2024-12-31
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
diabetes
Primary Purpose
Diagnostic
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorControl 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. | Dexcom Generation 6 CGM (Dexcom Gen6) device Standing orders for blood sugars less than 100 will allow for administration of glucose replacement in the intervention group based on Dexcom Gen6 readings. |
ExperimentalTreatment Group 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. | Dexcom Generation 6 CGM (Dexcom Gen6) device Standing orders for blood sugars less than 100 will allow for administration of glucose replacement in the intervention group based on Dexcom Gen6 readings. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of Hypoglycemia Events during hospitalization | Dexcom Gen6 readings | Up to 10 days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of Hyperglycemia Events during hospitalization | Dexcom Gen6 readings | Up to 10 days |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
Baylor Research InstituteNo contact data.
1 Study Locations in 1 Countries
Texas
Baylor Scott & White Medical Center - Temple, Temple, Texas, 76508, United States