Diabetes Mellitus
Conditions
Brief summary
Several observational studies have shown that uncontrolled hyperglycemia in hospitalized patients in the non-critical care, non-Intensive Care Unit (non-ICU) setting is associated with prolonged length of stay, increased mortality and an increased incidence of infections. Randomized clinical trials in both the critical and the non-ICU settings have shown that by improving glucose control there is a decrease in the incidence of infections, length of stay and inpatient health care costs. Continuous glucose monitoring (CGM) systems have evolved as useful devices providing excellent clinical care in patients with Diabetes Mellitus (DM). These systems detect glucose in subcutaneous interstitial fluid using a glucose sensor that transmits glucose measurements to a receiving device that reads out average glucose levels every couple of minutes. In this clinical trial the investigators propose to examine the clinical use of CGM in hospitalized patients with Diabetes Mellitus type 2 (DM2). CGM use may improve glucometric values and clinical outcomes in hospitalized individuals with Diabetes Mellitus type 2 (DM2). We use CGM devices to monitor but also to transmit glucose values wirelessly to monitoring devices that are in the nursing station. Half of the participants are placed on Real Time CGM (alarms turned on) and half of them are placed on blinded CGM values (alarms turned off). Nursing staff will be notified when glucose is \<85 mg/dl , in order to treat and potentially prevent a potential hypoglycemic episode.
Interventions
DEVICEContinuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose
Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose
Testing Blood Glucose levels with Point of Care (POC) blood glucose
Sponsors
DexCom, Inc.
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of Diabetes Mellitus type 2 (DM2) on insulin
Exclusion criteria
* Patients that are expected to require a hospital stay ≤3 days * Pregnant patients * Subjects that have significant hyperglycemia or Diabetic Ketoacidosis (DKA) that requires treatment with intravenous insulin infusion * Patients receiving glucocorticosteroids in doses (equivalent) to ≥ 20 mg of hydrocortisone/day * Any mental condition rendering the subject incapable of understanding the objectives and potential consequences of the study * Patients that need hospitalization in the critical care (ICU) setting. * History of Diabetes Mellitus type 1 (DM1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Time Spent in Hyperglycemia > 180 mg/dL | Through study completion, during hospital stay, an average of 1 week |
| Percentage of Time Spent in Significant Hyperglycemia (>300 mg/dL) | Through study completion, during hospital stay, an average of 1 week |
| Number of Participants With Hypoglycemic Events (< 70mg/dL) | Through study completion, during hospital stay, an average of 1 week |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuous Glucose Monitoring and Point of Care Blood Glucose Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose
Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose: Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose | 6 |
| Point of Care (POC) Blood Glucose Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only
Point of Care (POC) blood glucose: Testing Blood Glucose levels with Point of Care (POC) blood glucose | 7 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Minor Bleeding at site of device insertion | 1 | 0 |
| Overall Study | Transferred to ICU | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Continuous Glucose Monitoring and Point of Care Blood Glucose | Total | Point of Care (POC) Blood Glucose |
|---|---|---|---|
| A1c, % | 7.6 % of glycated hemoglobin STANDARD_DEVIATION 1.3 | 8.0 % of glycated hemoglobin STANDARD_DEVIATION 1.8 | 8.4 % of glycated hemoglobin STANDARD_DEVIATION 2.4 |
| Age, Continuous | 70.2 years STANDARD_DEVIATION 6.4 | 69.1 years STANDARD_DEVIATION 8 | 67.9 years STANDARD_DEVIATION 9.6 |
| Body Mass Index | 33.1 kg/m^2 STANDARD_DEVIATION 9.3 | 32.0 kg/m^2 STANDARD_DEVIATION 7.1 | 30.9 kg/m^2 STANDARD_DEVIATION 4.9 |
| DM duration | 22 years STANDARD_DEVIATION 12.9 | 20.2 years STANDARD_DEVIATION 9.7 | 18.4 years STANDARD_DEVIATION 6.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 12 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 7 |
| other Total, other adverse events | 2 / 6 | 0 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 |
Outcome results
Primary
Number of Participants With Hypoglycemic Events (< 70mg/dL)
Time frame: Through study completion, during hospital stay, an average of 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitoring and Point of Care Blood Glucose | Number of Participants With Hypoglycemic Events (< 70mg/dL) | 2 Participants |
| Point of Care (POC) Blood Glucose | Number of Participants With Hypoglycemic Events (< 70mg/dL) | 6 Participants |
Primary
Percentage of Time Spent in Hyperglycemia > 180 mg/dL
Time frame: Through study completion, during hospital stay, an average of 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring and Point of Care Blood Glucose | Percentage of Time Spent in Hyperglycemia > 180 mg/dL | 35.47 percentage of time spent > 180mg/dL | Standard Deviation 14.71 |
| Point of Care (POC) Blood Glucose | Percentage of Time Spent in Hyperglycemia > 180 mg/dL | 35.25 percentage of time spent > 180mg/dL | Standard Deviation 29.38 |
Primary
Percentage of Time Spent in Significant Hyperglycemia (>300 mg/dL)
Time frame: Through study completion, during hospital stay, an average of 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring and Point of Care Blood Glucose | Percentage of Time Spent in Significant Hyperglycemia (>300 mg/dL) | 3.28 percent of time spent > 300mg/dL | Standard Deviation 5.65 |
| Point of Care (POC) Blood Glucose | Percentage of Time Spent in Significant Hyperglycemia (>300 mg/dL) | 5.52 percent of time spent > 300mg/dL | Standard Deviation 12.64 |