Trial Outcomes & Findings for Dexcom Continuous Glucose Monitoring in Long-term Care (NCT NCT04818242)
NCT ID: NCT04818242
Last Updated: 2023-11-13
Results Overview
The number of participants with hypoglycemia detected, where hypoglycemia is defined as blood glucose (BG) of less than 70 mg/dL.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
During hospitalization (up to 60 days of admission)
Results posted on
2023-11-13
Participant Flow
Participants were recruited from the Emory Wesley Woods Hospital and A.G. Rhodes nursing home in Atlanta, Georgia. Participant enrollment began April 19, 2021 and all follow-up assessments were completed by October 21, 2022.
Participant milestones
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
Patients in the standard of care study arm wearing a blinded continuous glucose monitoring (CGM) and receiving point-of-care (POC) testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
Patients in the continuous glucose monitoring (CGM) with glucose telemetry system (CGM-GTS) study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=50 Participants
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=47 Participants
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.5 years
STANDARD_DEVIATION 10.6 • n=50 Participants
|
75.0 years
STANDARD_DEVIATION 11.8 • n=47 Participants
|
74.7 years
STANDARD_DEVIATION 11.0 • n=97 Participants
|
|
Age, Customized
Age 70 or greater
|
32 Participants
n=50 Participants
|
31 Participants
n=47 Participants
|
63 Participants
n=97 Participants
|
|
Age, Customized
Age less than 70
|
18 Participants
n=50 Participants
|
16 Participants
n=47 Participants
|
34 Participants
n=97 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=50 Participants
|
29 Participants
n=47 Participants
|
65 Participants
n=97 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=50 Participants
|
18 Participants
n=47 Participants
|
32 Participants
n=97 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
50 participants
n=50 Participants
|
47 participants
n=47 Participants
|
97 participants
n=97 Participants
|
|
Body mass index (BMI)
|
29.4 kg/m^2
STANDARD_DEVIATION 7.3 • n=50 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 8.6 • n=47 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 7.9 • n=97 Participants
|
|
HbA1c
|
8.14 percent of RBCs with glycated hemoglobin
STANDARD_DEVIATION 2.5 • n=50 Participants
|
7.97 percent of RBCs with glycated hemoglobin
STANDARD_DEVIATION 1.9 • n=47 Participants
|
8.06 percent of RBCs with glycated hemoglobin
STANDARD_DEVIATION 2.2 • n=97 Participants
|
PRIMARY outcome
Timeframe: During hospitalization (up to 60 days of admission)Population: POC data is unavailable for one participant in the POC study arm.
The number of participants with hypoglycemia detected, where hypoglycemia is defined as blood glucose (BG) of less than 70 mg/dL.
Outcome measures
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=49 Participants
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=47 Participants
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Number of Participants Experiencing Hypoglycemia (BG<70 mg/dL)
|
4 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: During hospitalization (up to 60 days of admission)Clinically significant hypoglycemia is defined as blood glucose levels less than 54 mg/dL.
Outcome measures
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=50 Participants
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=47 Participants
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Number of Participants Experiencing Clinically Significant Hypoglycemia (BG<54 mg/dL)
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: During hospitalization (up to 60 days of admission)Glycemic control is measured by time that blood glucose levels are in the range of 70 to 180 mg/dL.
Outcome measures
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=50 Participants
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=47 Participants
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Time in Range (TIR) Between 70-180 mg/dL
|
48.8 percentage of time
Standard Deviation 28.0
|
53.4 percentage of time
Standard Deviation 30.2
|
SECONDARY outcome
Timeframe: During hospitalization (up to 60 days of admission)The average number of events of nocturnal hypoglycemic events across all participants for BG \< 70 mg/dL and \<54 mg/dL occurring between 22:00 and 06:00.
Outcome measures
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=50 Participants
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=47 Participants
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Number of Events of Nocturnal Hypoglycemia
Blood glucose <70 mg/dL
|
0.42 events
Standard Deviation 1.23
|
0.55 events
Standard Deviation 1.54
|
|
Number of Events of Nocturnal Hypoglycemia
Blood glucose <54 mg/dL
|
0.28 events
Standard Deviation 0.88
|
0.19 events
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: During hospitalization (up to 60 days of admission)Population: POC data is unavailable for one participant in the POC study arm.
The total number of events of hypoglycemia events (BG \<70 mg/dL and \<54 mg/dL) across participants.
Outcome measures
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=49 Participants
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=47 Participants
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Number of Hypoglycemia Events
Blood glucose <70 mg/dL
|
4 events
|
13 events
|
|
Number of Hypoglycemia Events
Blood glucose <54 mg/dL
|
0 events
|
1 events
|
SECONDARY outcome
Timeframe: During hospitalization (up to 60 days of admission)The percent of time in hypoglycemia, defined as blood glucose level \<70 mg/dL, is assessed.
Outcome measures
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=50 Participants
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=47 Participants
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Time in Hypoglycemia (BG<70 mg/dL)
|
1.18 percentage of time
Standard Deviation 3.5
|
0.83 percentage of time
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: During hospitalization (up to 60 days of admission)The percentage of time in hypoglycemia with blood glucose levels less than 54 mg/dL.
Outcome measures
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=50 Participants
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=47 Participants
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Percent of Time in Hypoglycemia (BG<54 mg/dL)
|
0.6 percentage of time
Standard Deviation 2.2
|
0.2 percentage of time
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: During hospitalization (up to 60 days of admission)The percentage of time in hyperglycemia with blood glucose levels greater than 180 mg/dL.
Outcome measures
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=50 Participants
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=47 Participants
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Percent of Time in Hyperglycemia (BG > 180 mg/dL)
|
49.1 percentage of time
Standard Deviation 28.1
|
45.8 percentage of time
Standard Deviation 30.7
|
SECONDARY outcome
Timeframe: During hospitalization (up to 60 days of admission)The percentage of time in hyperglycemia with blood glucose levels \>250 mg/dL.
Outcome measures
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=50 Participants
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=47 Participants
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Percent of Time in Hyperglycemia (BG>250 mg/dL)
|
17.8 percentage of time
Standard Deviation 22.8
|
16.5 percentage of time
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: During hospitalization (up to 60 days of admission)The number of events of prolonged hypoglycemia, defined as \> 1 and 2 hours, as determined by CGM.
Outcome measures
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=50 Participants
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=47 Participants
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Number of Events of Prolonged Hypoglycemia
Blood glucose <70 mg/dL
|
0.12 prologed hypoglycemia events
Standard Deviation 0.52
|
0.04 prologed hypoglycemia events
Standard Deviation 0.29
|
|
Number of Events of Prolonged Hypoglycemia
Blood glucose <54 mg/dL
|
0.12 prologed hypoglycemia events
Standard Deviation 0.52
|
0.04 prologed hypoglycemia events
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: During hospitalization (up to 60 days of admission)The number of hypoglycemia events during the day and night in the POC testing group and the CGM-GTS group.
Outcome measures
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=50 Participants
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=47 Participants
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Number of Hypoglycemia Events During the Day and Night
Blood glucose <70 mg/dL
|
1.04 events
Standard Deviation 2.72
|
1.70 events
Standard Deviation 3.21
|
|
Number of Hypoglycemia Events During the Day and Night
Blood glucose <54 mg/dL
|
0.58 events
Standard Deviation 2.00
|
0.64 events
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: During hospitalization (up to 60 days of admission)Number of events of hyperglycemia \> 180 mg/dL during the day and night between POC testing group and CGM-GTS group
Outcome measures
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=96 blood glucose tests
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=97 blood glucose tests
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Number of Events of Hyperglycemia > 180 mg/dL
|
77 blood glucose tests
|
96 blood glucose tests
|
SECONDARY outcome
Timeframe: During hospitalization (up to 60 days of admission)Number of events of hyperglycemia \> 240 mg/dL during the day and night between POC testing group and CGM-GTS group
Outcome measures
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=96 blood glucose tests
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=97 blood glucose tests
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Number of Events of Hyperglycemia > 240 mg/dL
|
54 blood glucose tests
|
75 blood glucose tests
|
SECONDARY outcome
Timeframe: During hospitalization (up to 60 days of admission)Population: POC data is unavailable for one participant in the POC study arm.
The percentage of POC blood glucose readings within the target BG range of 70 and 180 mg/dL.
Outcome measures
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=49 Participants
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=47 Participants
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Percentage of POC BG Readings Within Target BG of 70 and 180 mg/dL
|
68 percentage of tests
Standard Deviation 33
|
61 percentage of tests
Standard Deviation 27
|
SECONDARY outcome
Timeframe: During hospitalization (up to 60 days of admission)Mean amplitude of glycemic excursions (MAGE), together with mean and standard deviation (SD), is the parameter for assessing glycemic variability and is calculated based on the arithmetic mean of differences between consecutive peaks and nadirs of differences greater than one SD of mean glycemia. It is designated to assess major glucose swings and exclude minor ones.
Outcome measures
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=50 Participants
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=47 Participants
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE)
|
62.17 mg/dL
Standard Deviation 24.0
|
64.03 mg/dL
Standard Deviation 27.5
|
SECONDARY outcome
Timeframe: During hospitalization (up to 60 days of admission)The number of participants who experienced problems or issues while the sensor was being inserted was documented.
Outcome measures
| Measure |
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
n=50 Participants
Patients in the standard of care study arm wearing a blinded CGM and receiving POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
|
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
n=47 Participants
Patients in the CGM-GTS study arm having a single daily fasting POC testing and wearing a real-time Dexcom G6 with GTS, with providers adjusting oral or insulin therapy based on CGM-GTS profile information.
|
|---|---|---|
|
Number of Participants With Problems With Sensor Insertion
|
0 Participants
|
0 Participants
|
Adverse Events
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)
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