Trial Outcomes & Findings for Continuous Glucose Monitoring in Hospitalized Patients With Diabetes Mellitus (NCT NCT04653454)
NCT ID: NCT04653454
Last Updated: 2025-07-31
Results Overview
The absolute relative difference (ARD) was defined as the absolute difference between control - point of care (POC) glucose reading and the corresponding CGM reading divided by POC glucose reading and expressed as percentage. ARD was calculated as mean absolute relative difference (MARD) with standard deviation. MARD was calculated between matched pairs of POC (point of care) glucose readings and the closest CGM reading. MARD was summarized as mean (standard deviation) or median (range) for glucose readings \<70 mg/dl, 70-180 mg/dL, \>180 mg/dl, 181-250mg/dl, \>250 mg/dl respectively.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
142 participants
Primary outcome timeframe
From date of enrollment and until discharge from the hospital up to 30 days.
Results posted on
2025-07-31
Participant Flow
Participant milestones
| Measure |
CGM Patients
Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff.
Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time.
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|---|---|
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Overall Study
STARTED
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142
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Overall Study
COMPLETED
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101
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Overall Study
NOT COMPLETED
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41
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Reasons for withdrawal
| Measure |
CGM Patients
Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff.
Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Physician Decision
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40
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Baseline Characteristics
Continuous Glucose Monitoring in Hospitalized Patients With Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
CGM Patients
n=142 Participants
Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff.
Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time.
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|---|---|
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Age, Continuous
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59.97 years
STANDARD_DEVIATION 12.68 • n=5 Participants
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Sex: Female, Male
Female
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48 Participants
n=5 Participants
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Sex: Female, Male
Male
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94 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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4 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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135 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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2 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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6 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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19 Participants
n=5 Participants
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Race (NIH/OMB)
White
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112 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=5 Participants
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Region of Enrollment
United States
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142 participants
n=5 Participants
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PRIMARY outcome
Timeframe: From date of enrollment and until discharge from the hospital up to 30 days.Population: 3316 total CGM-POC readings pairs were collected. Those 3316 POC-CGM reading pairs were further broken down into the following categories based on the POC value: CGM-POC Pairs with POC\<70 mg/dL, CGM-POC Pairs with POC between 70-180 mg/dL, CGM-POC Pairs with POC between 181-250mg/dl, CGM-POC Pairs with POC\>250 mg/dl, respectively.
The absolute relative difference (ARD) was defined as the absolute difference between control - point of care (POC) glucose reading and the corresponding CGM reading divided by POC glucose reading and expressed as percentage. ARD was calculated as mean absolute relative difference (MARD) with standard deviation. MARD was calculated between matched pairs of POC (point of care) glucose readings and the closest CGM reading. MARD was summarized as mean (standard deviation) or median (range) for glucose readings \<70 mg/dl, 70-180 mg/dL, \>180 mg/dl, 181-250mg/dl, \>250 mg/dl respectively.
Outcome measures
| Measure |
CGM Patients
n=3316 CGM-POC pairs
Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff.
Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time.
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|---|---|
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Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD)
MARD for CGM-POC pairs with POC <70 mg/dL
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22.6 MARD percentage
Standard Deviation 19.5
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Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD)
MARD for CGM-POC pairs with POC between 70-180 mg/dL
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14.6 MARD percentage
Standard Deviation 12.8
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Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD)
MARD for CGM-POC pairs with POC between 181-250 mg/dL
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11.7 MARD percentage
Standard Deviation 10.1
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Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD)
MARD for CGM-POC pairs with POC>250 mg/dL
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10.4 MARD percentage
Standard Deviation 8.7
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Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD)
MARD for all CGM-POC pairs
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13.7 MARD percentage
Standard Deviation 12.3
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SECONDARY outcome
Timeframe: From date of enrollment and until discharge from the hospital up to 30 days.The incidence of hypoglycemic episodes
Outcome measures
| Measure |
CGM Patients
n=101 Participants
Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff.
Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time.
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|---|---|
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CGM Recorded Hypoglycemia Episodes
Hypoglycemic Episodes <54 mg/dL
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0.47 Hypoglycemic Episodes
Standard Deviation 1.94
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CGM Recorded Hypoglycemia Episodes
Hypoglycemic Episodes <70 mg/dL
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1.45 Hypoglycemic Episodes
Standard Deviation 3.33
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SECONDARY outcome
Timeframe: From date of enrollment and until discharge from the hospital up to 30 days.CGM recorded duration of hypoglycemic episodes
Outcome measures
| Measure |
CGM Patients
n=101 Participants
Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff.
Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time.
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|---|---|
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CGM Recorded Duration of Hypoglycemic Episodes
Hypoglycemic Episodes <54 mg/dL
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37.810 Minutes
Standard Deviation 191.77
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CGM Recorded Duration of Hypoglycemic Episodes
Hypoglycemic Episodes <70 mg/dL
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162.81 Minutes
Standard Deviation 572.29
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SECONDARY outcome
Timeframe: From date of enrollment and until discharge from the hospital up to 30 days.The incidence of hyperglycemic episodes
Outcome measures
| Measure |
CGM Patients
n=101 Participants
Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff.
Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time.
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|---|---|
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CGM Recorded Hyperglycemic Episodes
Hyperglycemic Episodes >180 mg/dL
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10.216 Hyperglycemic Episodes
Standard Deviation 12.794
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CGM Recorded Hyperglycemic Episodes
Hyperglycemic Episodes >250 mg/dL
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5.935 Hyperglycemic Episodes
Standard Deviation 8.958
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SECONDARY outcome
Timeframe: From date of enrollment and until discharge from the hospital up to 30 days.The duration of hyperglycemic episodes
Outcome measures
| Measure |
CGM Patients
n=101 Participants
Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff.
Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time.
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|---|---|
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CGM Recorded Duration of Hyperglycemic Episodes
Hyperglycemic Episodes >250 mg/dL
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801.99 Minutes
Standard Deviation 1171.28
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CGM Recorded Duration of Hyperglycemic Episodes
Hyperglycemic Episodes >180 mg/dL
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2419.44 Minutes
Standard Deviation 2804.85
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SECONDARY outcome
Timeframe: From date of enrollment and until discharge from the hospital up to 30 days.The correlation between MARD point of care (POC) and Creatinine, Glomerular Filtration Rate (GFR), Bicarbonate, Hemoglobin (Hb), Mean Arterial Pressure (MAP), and Peripheral Oxygen Saturation (SpO2). The Spearman's rank correlation method was used to calculate the correlation coefficient.
Outcome measures
| Measure |
CGM Patients
n=101 Participants
Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff.
Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time.
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|---|---|
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Variation in Mean Absolute Relative Difference (MARD) in Relation to Pharmacological and Physiological Parameters
Creatinine
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-0.08 Correlation Coefficient
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Variation in Mean Absolute Relative Difference (MARD) in Relation to Pharmacological and Physiological Parameters
139GFR
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-0.02 Correlation Coefficient
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Variation in Mean Absolute Relative Difference (MARD) in Relation to Pharmacological and Physiological Parameters
Bicarbonate
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0.024 Correlation Coefficient
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Variation in Mean Absolute Relative Difference (MARD) in Relation to Pharmacological and Physiological Parameters
Hb
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-0.012 Correlation Coefficient
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Variation in Mean Absolute Relative Difference (MARD) in Relation to Pharmacological and Physiological Parameters
MAP
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0.003 Correlation Coefficient
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Variation in Mean Absolute Relative Difference (MARD) in Relation to Pharmacological and Physiological Parameters
SpO2
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0.034 Correlation Coefficient
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SECONDARY outcome
Timeframe: From date of enrollment and until discharge from the hospital up to 30 days.Mortality during index hospitalization
Outcome measures
| Measure |
CGM Patients
n=101 Participants
Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff.
Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time.
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|---|---|
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In Hospital Mortality
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2 Participants
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SECONDARY outcome
Timeframe: From date of enrollment and until discharge from the hospital up to 30 days.Duration of hospital stay in hours
Outcome measures
| Measure |
CGM Patients
n=101 Participants
Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff.
Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time.
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|---|---|
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Hospitalization Length of Stay
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116.5 Hours
Interval 74.73 to 215.43
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SECONDARY outcome
Timeframe: From date of enrollment up to 60 days.Mortality rate at 30 days post discharge from the hospital
Outcome measures
| Measure |
CGM Patients
n=101 Participants
Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff.
Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time.
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|---|---|
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Mortality Rate at 30 Days
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0 Participants
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SECONDARY outcome
Timeframe: From date of enrollment up to 60 days.Number of re-hospitalization events that occurred at the same institution within 30 days from the discharge date of the preceding admission.
Outcome measures
| Measure |
CGM Patients
n=188 Hospitalizations Events
Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff.
Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time.
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|---|---|
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Number of Re-hospitalization Events at the Same Institution Within 30 Days From the Discharge Date of the Preceding Admission.
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60 Hospitalizations Events
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Adverse Events
CGM Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place