Trial Outcomes & Findings for Expanding Use of CGM in Critical Care: Impact on Nurse Work Patterns and Patient Outcomes (NCT NCT05571397)
NCT ID: NCT05571397
Last Updated: 2026-02-06
Results Overview
Percent of time in target glycemic ranges: 100-180 mg/dl, 70-180mg/dl, 140-180mg/d
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
201 participants
Primary outcome timeframe
For duration of MICU stay which was an average of 7.6 ± 4.1 days/patient
Results posted on
2026-02-06
Participant Flow
Participant milestones
| Measure |
Dexcom CGM
Dexcom G6
Dexcom G6: Continuous Glucose Monitor
|
Historical Controls
Matched historical controls
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Dexcom CGM
Dexcom G6
Dexcom G6: Continuous Glucose Monitor
|
Historical Controls
Matched historical controls
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Expanding Use of CGM in Critical Care: Impact on Nurse Work Patterns and Patient Outcomes
Baseline characteristics by cohort
| Measure |
Dexcom CGM
n=100 Participants
Dexcom G6
Dexcom G6: Continuous Glucose Monitor
|
Historical Controls
n=100 Participants
Matched historical controls
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 15.3 • n=41 Participants
|
52.7 years
STANDARD_DEVIATION 15.4 • n=1581 Participants
|
53.7 years
STANDARD_DEVIATION 15.3 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=41 Participants
|
53 Participants
n=1581 Participants
|
100 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=41 Participants
|
47 Participants
n=1581 Participants
|
100 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=41 Participants
|
98 Participants
n=1581 Participants
|
198 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=41 Participants
|
19 Participants
n=1581 Participants
|
34 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
83 Participants
n=41 Participants
|
77 Participants
n=1581 Participants
|
160 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=41 Participants
|
100 participants
n=1581 Participants
|
200 participants
n=4626 Participants
|
|
Type of Diabetes
Type 2 Diabetes
|
59 Participants
n=41 Participants
|
60 Participants
n=1581 Participants
|
119 Participants
n=4626 Participants
|
|
Type of Diabetes
Type 1 Diabetes
|
26 Participants
n=41 Participants
|
32 Participants
n=1581 Participants
|
58 Participants
n=4626 Participants
|
|
Type of Diabetes
No history of diabetes
|
14 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
22 Participants
n=4626 Participants
|
|
Type of Diabetes
Other type of diabetes
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: For duration of MICU stay which was an average of 7.6 ± 4.1 days/patientPercent of time in target glycemic ranges: 100-180 mg/dl, 70-180mg/dl, 140-180mg/d
Outcome measures
| Measure |
Dexcom CGM
n=100 Participants
Dexcom G6
Dexcom G6: Continuous Glucose Monitor
|
Historical Controls
n=100 Participants
Matched historical controls
|
|---|---|---|
|
Percentage of Time in Target Glycemic Ranges
140-180mg/dl
|
37 percentage of time in target ranges
Interval 34.0 to 40.0
|
30 percentage of time in target ranges
Interval 27.0 to 33.0
|
|
Percentage of Time in Target Glycemic Ranges
70-180mg/dl
|
76 percentage of time in target ranges
Interval 72.0 to 79.0
|
65 percentage of time in target ranges
Interval 61.0 to 69.0
|
|
Percentage of Time in Target Glycemic Ranges
100-180mg/dl
|
69 percentage of time in target ranges
Interval 66.0 to 73.0
|
61 percentage of time in target ranges
Interval 56.0 to 64.0
|
SECONDARY outcome
Timeframe: For duration of MICU stay which was an average of 7.6 ± 4.1 days/patientPercent of time in hypoglycemic ranges \<70mg/dl and \<55mg/dl
Outcome measures
| Measure |
Dexcom CGM
n=100 Participants
Dexcom G6
Dexcom G6: Continuous Glucose Monitor
|
Historical Controls
n=100 Participants
Matched historical controls
|
|---|---|---|
|
Percent of Time in Hypoglycemic Ranges
<54mg/dl
|
0.06 Percent of time in hypoglycemic ranges
Interval 0.0 to 0.16
|
0.08 Percent of time in hypoglycemic ranges
Interval 0.0 to 0.17
|
|
Percent of Time in Hypoglycemic Ranges
<70mg/dl
|
0.41 Percent of time in hypoglycemic ranges
Interval 0.08 to 0.73
|
0.19 Percent of time in hypoglycemic ranges
Interval 0.04 to 0.34
|
Adverse Events
Dexcom CGM
Serious events: 0 serious events
Other events: 8 other events
Deaths: 22 deaths
Historical Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 23 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexcom CGM
n=100 participants at risk
Dexcom G6
Dexcom G6: Continuous Glucose Monitor
|
Historical Controls
n=100 participants at risk
Matched historical controls
|
|---|---|---|
|
Investigations
Failure to Reconsent
|
8.0%
8/100 • Number of events 8 • Adverse event data was collected for each individual while they were enrolled in the study and wearing the continuous glucose monitor. This was an average of 7.6 ± 4.1 days.
|
0.00%
0/100 • Adverse event data was collected for each individual while they were enrolled in the study and wearing the continuous glucose monitor. This was an average of 7.6 ± 4.1 days.
|
|
Investigations
Failure to remove CGM when transition to hospice care
|
2.0%
2/100 • Number of events 2 • Adverse event data was collected for each individual while they were enrolled in the study and wearing the continuous glucose monitor. This was an average of 7.6 ± 4.1 days.
|
0.00%
0/100 • Adverse event data was collected for each individual while they were enrolled in the study and wearing the continuous glucose monitor. This was an average of 7.6 ± 4.1 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60