Baltimore VA Medical Center
Baltimore, Maryland, 21201, United States
Location contact
Ilias Spanakis, MD
PRINCIPAL_INVESTIGATOR
Jade Churchill, BS
CONTACT
410 605 7000 ext. 53593
William H Scott, MA
CONTACT
410-605-7000 ext. 53558
NCT Number: NCT07221812
Among the diffident groups of patients, those with chronic and severe medical conditions are more likely to be readmitted to the hospital. It is not surprising therefore that patients with diabetes have high readmission rates. Patients with diabetes have 40% higher re-hospitalization rates compared with those patients without diabetes, with 30-day readmission rates reported to range between 14% and 26%. It should be noted that almost 30% of the patients with diabetes are experiencing two or more hospital admissions per year, accounting for more than 50% of total hospitalizations and hospital health care costs. This research application will evaluate whether the initiation of Continuous Glucose Monitor (CGM) devices at the time of hospital discharge will lead to better glucose control and health outcomes compared to the use of "finger sticks" Point of Care (POC) following hospital discharge among patients with diabetes. This study will be a two arm (Real Time CGM vs POC) single center RCT at the Baltimore VA Medical Center. One hundred and twenty individuals will be recruited and randomly assigned (1:1) to either Real Time CGM or to POC following hospital discharge. All subjects will be followed from for 3 months post hospital discharge.
Trial opening soon.
Get Notified18 year–90 year
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21201, United States
Ilias Spanakis, MD
PRINCIPAL_INVESTIGATOR
Jade Churchill, BS
CONTACT
410 605 7000 ext. 53593
William H Scott, MA
CONTACT
410-605-7000 ext. 53558
Utilizing CGM devices for patients with diabetes at hospital discharge can be a feasible and easily to implement intervention, improving glycemic control. Compared to Point of Care (POC) glucose testing, CGM devices can provide an easier and painless method for monitoring blood glucose levels. By checking glucose values every couple of minutes, having alarm features and by having the ability to provide remote glucose monitoring (with software applications -smartphones-Bluetooth and internet), CGMs can have many benefits for patients with diabetes following hospital discharge: They can help patients with diabetes and their providers to achieve better glucose control after hospital discharge, reducing hyperglycemia, hypoglycemia and glucose variability, conditions that are associated with adverse outcomes among patients with diabetes. As extreme glucose values (hyperglycemia -hypoglycemia- glucose variability) are more common during illness in patients with diabetes, frequent glucose monitoring by CGMs can help patients as also medical providers to utilize them as another "vital sign", leading to early interventions.
These early interventions can have many other potential beneficial health effects. By monitoring glucose values closely, they can decrease hyperglycemia and hypoglycemia leading to better glucose control, reduced post discharge complications and as a result decrease readmission rates and mortality. Hospital readmissions, especially when they occur during the early period after hospital discharge, represent a marker of poor-quality healthcare delivery and have been associated with increased health care costs. In an effort to reduce readmission rates, the Centers for Medicare and Medicaid Services (CMS) Readmissions Reduction Program penalizes hospitals with high 30-day readmission rates. Among patients, those with diabetes have high readmission rates, ranging between 14% and 26%. This is translated to increased hospital expenses: It has been estimated that the cost of 30-day readmissions for patients with diabetes is nearly $25 billion. In addition, using CGM devices early upon discharge can lead to decreasing Emergency Department (ED) visits and post discharge mortality.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Dexcom G7 (real-time data) will be placed on all individuals randomized to the Intervention group. Their data will be shared with health care providers using a CGM software application. Providers will use this information during scheduled contact visits to make treatment decisions.
The control group will use "finger sticks", usual Point of Care (POC), to measure blood glucose values. This information will be shared with providers and used for all treatment decisions at scheduled visits.
Time frame: 90 days
HbA1c
Time frame: 90 days
Hypoglycemia < 70 mg/dL
Time frame: 90 days
Glucose Variability- Coefficient of Variation (CV%)
Time frame: 90 days
Change TIR (70-180 mg/dL)
Time frame: 90 days
GRI (Hyperglycemia Component/Hypoglycemia Component)
Time frame: 90 days
Change in Average glucose values (mg/dL)
Time frame: 30 days
Change in readmission rates
Time frame: 60 days
Change in 60-day admission rates
Time frame: 90 days
Change in 90-day readmission
Time frame: 30 days
Change in ED visits at 30 days
Time frame: 60 days
Change in ED visits at 60 days
Time frame: 90 days
Change in ED visits at 90 days
Time frame: 30 days
Change in Mortality rates at 30 days
Time frame: 60 days
Change in mortality rates at 60 days.
Time frame: 90 days
Change in mortality rates at 90 days
Contact information is provided by the study sponsor or research team.
Jade Churchill, BS
CONTACT
410 605 7000 ext. 53595
William H Scott, MA
CONTACT
410 605 7000 ext. 53558
University of Maryland, Baltimore
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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