About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years of age
Patients with diabetes who are anticipated to be treated with any type of insulin after hospital discharge and with or without non-insulin medications (excluding those who are expected to be treated with correctional-sliding scale insulin regimens only
Uncontrolled glycemic control, defined as hyperglycemia with HbA1c ≥8%
Disqualifiers
Patients with diabetes who are anticipated to be treated with diet only, any combination of non-insulin antidiabetic drugs only, sliding scale correctional insulins (with or without non-insulin medications) after hospital discharge.
Patients at the time of screening on insulin pumps or CGMs
Pregnant patients
Patients with extensive skin disease or allergies that preclude wearing the CGM sensor
Trial design
Parallel
Treatments tested in this trial
Continuous Glucose Monitor
DeviceThe 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.
Control Group
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in glycemic control
HbA1c
Change in hypoglycemia events
Hypoglycemia \< 70 mg/dL
Change in Glucose Variability
Glucose Variability- Coefficient of Variation (CV%)
Change in Time In Range (TIR)
Change TIR (70-180 mg/dL)
Secondary outcomes
Change in 30-day readmission rates
Change in readmission rates
Change in 60-day readmission rates
Change in 60-day admission rates
Change in 90-day readmission rates
Change in 90-day readmission
Change in Emergency Department (ED) visits at 30-days
Change in ED visits at 30 days
Sponsors and contacts
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University of Maryland, Baltimore
Lead sponsor
DexCom, Inc.
Collaborator
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