Trial Outcomes & Findings for Managing Type 1 and High Risk Type 2 Diabetes in the Hospital Setting: Glucose as a Vital Sign (NCT NCT03068273)
NCT ID: NCT03068273
Last Updated: 2025-10-15
Results Overview
Percentage of time a person's blood glucose level stays within a specific range of 70-180 mg/dL
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
157 participants
Primary outcome timeframe
Up to 30 days
Results posted on
2025-10-15
Participant Flow
Participant milestones
| Measure |
Intervention
Patients in the intervention group, CGM data will be viewed real-time.
Real-time CGM data
|
Control
Patients in the control group, CGM data is blinded to all and only gathered for comparison purposes to intervention group.
Real-time CGM data
|
Observational T1D
Hospitalized patients with T1D placed on a CGM
|
|---|---|---|---|
|
Overall Study
STARTED
|
57
|
53
|
47
|
|
Overall Study
COMPLETED
|
57
|
53
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing data at hospital admission.
Baseline characteristics by cohort
| Measure |
Intervention
n=57 Participants
For type 2 patients in the intervention group, CGM data will be viewed real-time.
Real-time CGM data
|
Control
n=53 Participants
For type 2 patients in the control group, CGM data is blinded to all and only gathered for comparison purposes to intervention group.
Real-time CGM data
|
Observational T1D
n=47 Participants
For type 1 patients in the observational group, CGM data will be viewed real-time.
Real-time CGM data
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.88 years
STANDARD_DEVIATION 14.01 • n=57 Participants
|
60.94 years
STANDARD_DEVIATION 12.37 • n=53 Participants
|
43.6 years
STANDARD_DEVIATION 12.73 • n=47 Participants
|
61.94 years
STANDARD_DEVIATION 13.22 • n=157 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=57 Participants
|
30 Participants
n=53 Participants
|
22 Participants
n=47 Participants
|
82 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=57 Participants
|
23 Participants
n=53 Participants
|
25 Participants
n=47 Participants
|
75 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=57 Participants • Missing data at hospital admission.
|
42 Participants
n=52 Participants • Missing data at hospital admission.
|
16 Participants
n=47 Participants • Missing data at hospital admission.
|
97 Participants
n=156 Participants • Missing data at hospital admission.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=57 Participants • Missing data at hospital admission.
|
10 Participants
n=52 Participants • Missing data at hospital admission.
|
31 Participants
n=47 Participants • Missing data at hospital admission.
|
59 Participants
n=156 Participants • Missing data at hospital admission.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=57 Participants • Missing data at hospital admission.
|
0 Participants
n=52 Participants • Missing data at hospital admission.
|
0 Participants
n=47 Participants • Missing data at hospital admission.
|
0 Participants
n=156 Participants • Missing data at hospital admission.
|
|
Region of Enrollment
United States
|
57 participants
n=57 Participants
|
53 participants
n=53 Participants
|
47 participants
n=47 Participants
|
110 participants
n=157 Participants
|
|
Type 2 Diabetes Duration
|
16.23 years
STANDARD_DEVIATION 9.74 • n=56 Participants • Missing data at hospital admission. Explanation: Data not assessed in T1D observational arm
|
18.51 years
STANDARD_DEVIATION 12.04 • n=51 Participants • Missing data at hospital admission. Explanation: Data not assessed in T1D observational arm
|
—
|
17.37 years
STANDARD_DEVIATION 10.89 • n=107 Participants • Missing data at hospital admission. Explanation: Data not assessed in T1D observational arm
|
|
HbA1c at Hospital Admission
|
9.5 percentage
n=49 Participants • HbA1c was missing on patients
|
8.65 percentage
n=44 Participants • HbA1c was missing on patients
|
9.5 percentage
n=47 Participants • HbA1c was missing on patients
|
9.075 percentage
n=140 Participants • HbA1c was missing on patients
|
|
Point of Care (POC) Blood Glucose Testing at Hospital Admission
|
261 mg/dL
n=55 Participants • Missing data at hospital admission.
|
245.5 mg/dL
n=52 Participants • Missing data at hospital admission.
|
334.00 mg/dL
n=47 Participants • Missing data at hospital admission.
|
253.25 mg/dL
n=154 Participants • Missing data at hospital admission.
|
|
Serum Creatinine at Hospital Admission
|
1.00 mg/dL
n=57 Participants • Range not determined in this T1D observational arm
|
1.00 mg/dL
n=53 Participants • Range not determined in this T1D observational arm
|
—
|
1.00 mg/dL
n=110 Participants • Range not determined in this T1D observational arm
|
|
BMI
|
29.9 kg/m2
n=56 Participants • Missing data at hospital admission. Explanation: BMI not collected in this T1D observational arm
|
30.65 kg/m2
n=48 Participants • Missing data at hospital admission. Explanation: BMI not collected in this T1D observational arm
|
—
|
30.27 kg/m2
n=104 Participants • Missing data at hospital admission. Explanation: BMI not collected in this T1D observational arm
|
PRIMARY outcome
Timeframe: Up to 30 daysPercentage of time a person's blood glucose level stays within a specific range of 70-180 mg/dL
Outcome measures
| Measure |
Intervention
n=57 Participants
For type 2 patients in the intervention group, CGM data will be viewed real-time.
Real-time CGM data
|
Control
n=53 Participants
For type 2 patients in the control group, CGM data is blinded to all and only gathered for comparison purposes to intervention group.
Real-time CGM data
|
Observational T1D
n=47 Participants
For type 1 patients in the observational group, real-time CGM data was collected.
|
|---|---|---|---|
|
Type 2 Diabetes Blood Glucose Time in Range (70-180 mg/dL)
|
25.31 percentage of time during CGM use
Interval 11.78 to 42.97
|
19.89 percentage of time during CGM use
Interval 3.34 to 40.09
|
26.04 percentage of time during CGM use
Interval 10.4 to 49.57
|
PRIMARY outcome
Timeframe: Up to 30 daysPercentage of time a person's blood glucose level stays within a specific range on 70-200 mg/dL
Outcome measures
| Measure |
Intervention
n=57 Participants
For type 2 patients in the intervention group, CGM data will be viewed real-time.
Real-time CGM data
|
Control
n=53 Participants
For type 2 patients in the control group, CGM data is blinded to all and only gathered for comparison purposes to intervention group.
Real-time CGM data
|
Observational T1D
n=47 Participants
For type 1 patients in the observational group, real-time CGM data was collected.
|
|---|---|---|---|
|
Type 2 Diabetes Blood Glucose Time in Range (70-200 mg/dL)
|
42.82 percentage of time during CGM use
Interval 25.66 to 58.53
|
33.38 percentage of time during CGM use
Interval 10.9 to 55.74
|
33.57 percentage of time during CGM use
Interval 18.19 to 61.54
|
PRIMARY outcome
Timeframe: Up to 30 daysPercentage of time a person's blood glucose level stays within a specific range on 70-250 mg/dL
Outcome measures
| Measure |
Intervention
n=57 Participants
For type 2 patients in the intervention group, CGM data will be viewed real-time.
Real-time CGM data
|
Control
n=53 Participants
For type 2 patients in the control group, CGM data is blinded to all and only gathered for comparison purposes to intervention group.
Real-time CGM data
|
Observational T1D
n=47 Participants
For type 1 patients in the observational group, real-time CGM data was collected.
|
|---|---|---|---|
|
Type 2 Diabetes Blood Glucose Time in Range (70-250 mg/dL)
|
72.83 percentage of time during CGM use
Interval 59.03 to 83.57
|
63.95 percentage of time during CGM use
Interval 31.25 to 77.95
|
65.97 percentage of time during CGM use
Interval 44.1 to 87.0
|
SECONDARY outcome
Timeframe: Up to 30 daysPercentage of time a person's blood glucose level stays within a specific range \< 70 mg/dL
Outcome measures
| Measure |
Intervention
n=57 Participants
For type 2 patients in the intervention group, CGM data will be viewed real-time.
Real-time CGM data
|
Control
n=53 Participants
For type 2 patients in the control group, CGM data is blinded to all and only gathered for comparison purposes to intervention group.
Real-time CGM data
|
Observational T1D
n=47 Participants
For type 1 patients in the observational group, real-time CGM data was collected.
|
|---|---|---|---|
|
Percentage Time in Hypoglycemia (<70 mg/dL)
|
0 percentage of time during CGM use
Interval 0.0 to 0.0
|
0 percentage of time during CGM use
Interval 0.0 to 0.0
|
0 percentage of time during CGM use
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 30 daysPercentage of time a person's blood glucose level stays within a specific range \> 250 mg/dL
Outcome measures
| Measure |
Intervention
n=57 Participants
For type 2 patients in the intervention group, CGM data will be viewed real-time.
Real-time CGM data
|
Control
n=53 Participants
For type 2 patients in the control group, CGM data is blinded to all and only gathered for comparison purposes to intervention group.
Real-time CGM data
|
Observational T1D
n=47 Participants
For type 1 patients in the observational group, real-time CGM data was collected.
|
|---|---|---|---|
|
Percentage Time in Hyperglycemia (>250 mg/dL)
|
27.00 percentage of time during CGM use
Interval 16.01 to 40.97
|
32.96 percentage of time during CGM use
Interval 20.4 to 68.75
|
34.04 percentage of time during CGM use
Interval 5.9 to 55.9
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Observational T1D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 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