Trial Outcomes & Findings for Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety After Gastric Surgery (NCT NCT03353415)
NCT ID: NCT03353415
Last Updated: 2023-08-28
Results Overview
The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is \<70 mg/dl, comparing the masked versus the unmasked phases.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Results posted on
2023-08-28
Participant Flow
Patients with post-gastric surgery hypoglycemia were recruited from the Hypoglycemia Clinic at Joslin Diabetes Center, directed by Dr. Patti. The study was explained to potential participants initially in the clinical setting or during a subsequent telephone screening session. Recruitment took place between February of 2019 through December of 2021. The dexcom G4 was available for the first 13 participants. The remaining 10 participants wore the dexcom G6.
After enrollment, 1 participant was withdrawn and did not complete baseline evaluation (visit 1) due to hospitalization. Following baseline evaluation (visit 1), 2 participants were lost to followup and did not complete the masked CGM wear period. One additional participant was excluded due to missing data and therefore could not be included in the analyses.
Participant milestones
| Measure |
CGM Use
Each participant wore the Dexcom continuous glucose monitor (CGM) available at their time of participation. The Dexcom G4 became unavailable during the course of the study and later participants wore the Dexcom G6. During the first two weeks (Dexcom G4) or first 10 days (Dexcom G6), participants were not able to read the sensor glucose levels. In the second two weeks (Dexcom G4) or second 10 days (Dexcom G6), participants were able to read the sensor glucose levels. Frequency of hypoglycemia was compared between the two phases of the study (masked versus unmasked CGM).
Dexcom CGM: The CGM monitored sensor glucose levels in all participants. During the first two weeks (Dexcom G4) or first 10 days (Dexcom G6) of the study, participants were masked to the sensor glucose levels and needed to use other methods, such as a blood sample from a finger stick, to check their blood sugar. During the second two weeks (Dexcom G4) or second10 days (Dexcom G6), participants were able to see the sensor glucose levels displayed from the CGM. Participants were instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels developed.
|
|---|---|
|
Masked CGM Wear
STARTED
|
25
|
|
Masked CGM Wear
COMPLETED
|
23
|
|
Masked CGM Wear
NOT COMPLETED
|
2
|
|
Unmasked CGM Wear
STARTED
|
23
|
|
Unmasked CGM Wear
COMPLETED
|
22
|
|
Unmasked CGM Wear
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
CGM Use
Each participant wore the Dexcom continuous glucose monitor (CGM) available at their time of participation. The Dexcom G4 became unavailable during the course of the study and later participants wore the Dexcom G6. During the first two weeks (Dexcom G4) or first 10 days (Dexcom G6), participants were not able to read the sensor glucose levels. In the second two weeks (Dexcom G4) or second 10 days (Dexcom G6), participants were able to read the sensor glucose levels. Frequency of hypoglycemia was compared between the two phases of the study (masked versus unmasked CGM).
Dexcom CGM: The CGM monitored sensor glucose levels in all participants. During the first two weeks (Dexcom G4) or first 10 days (Dexcom G6) of the study, participants were masked to the sensor glucose levels and needed to use other methods, such as a blood sample from a finger stick, to check their blood sugar. During the second two weeks (Dexcom G4) or second10 days (Dexcom G6), participants were able to see the sensor glucose levels displayed from the CGM. Participants were instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels developed.
|
|---|---|
|
Masked CGM Wear
Lost to Follow-up
|
2
|
|
Unmasked CGM Wear
Excluded due to missing data.
|
1
|
Baseline Characteristics
Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety After Gastric Surgery
Baseline characteristics by cohort
| Measure |
CGM Use
n=25 Participants
Each participant wore the Dexcom continuous glucose monitor (CGM) available at their time of participation. The Dexcom G4 became unavailable during the course of the study and later participants wore the Dexcom G6. During the first two weeks (Dexcom G4) or first 10 days (Dexcom G6), participants were not able to read the sensor glucose levels. In the second two weeks (Dexcom G4) or second 10 days (Dexcom G6), participants were able to read the sensor glucose levels. Frequency of hypoglycemia was compared between the two phases of the study (masked versus unmasked CGM).
Dexcom CGM: The CGM monitored sensor glucose levels in all participants. During the first two weeks (Dexcom G4) or first 10 days (Dexcom G6) of the study, participants were masked to the sensor glucose levels and needed to use other methods, such as a blood sample from a finger stick, to check their blood sugar. During the second two weeks (Dexcom G4) or second10 days (Dexcom G6), participants were able to see the sensor glucose levels displayed from the CGM. Participants were instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels developed.
|
|---|---|
|
Age, Continuous
|
51.1 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
|
Hemoglobin A1c
|
5.3 percent
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Pre-operative Body Mass Index (BMI)
|
47.6 mg/k^2
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Current BMI
|
30.6 mg/k^2
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Years post-bariatric surgery
|
9.6 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Years between bariatric surgery and hypoglycemia onset
|
4.7 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Percentage of participants with a history of level III hypoglycemia (requiring assistance)
|
84 percentage of participants
n=5 Participants
|
|
Percentage of participants with a history of neuroglycopenia
|
100 percentage of participants
n=5 Participants
|
|
Visit 1 Edinburgh Hypoglycemia Symptom Scale (EHSS) Score
|
49.3 units on a scale (EHSS score)
STANDARD_DEVIATION 20.5 • n=5 Participants
|
|
Visit 1 Dumping Symptom Rating Scale (DSRS) Score
|
23.1 units on a scale (DSRS score)
STANDARD_DEVIATION 7.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is \<70 mg/dl, comparing the masked versus the unmasked phases.
Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Percentage of Time Sensor Glucose <70 mg/dL in the Masked Versus the Unmasked Phase.
|
4.7 Percentage of time
Standard Deviation 4.8
|
2.9 Percentage of time
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is \<60 mg/dl, comparing the masked versus the unmasked phases.
Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Percentage of Time Sensor Glucose <60mg/dL in the Masked Versus the Unmasked Phase
|
1.4 Percentage of time
Standard Deviation 1.7
|
0.7 Percentage of time
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is \<60 mg/dl, comparing the masked versus the unmasked phases.
Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Percentage of Time Sensor Glucose <54 mg/dL in the Masked Versus the Unmasked Phase
|
0.6 Percentage of time
Standard Deviation 0.8
|
0.2 Percentage of time
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Median Sensor Glucose Level During Masked Versus Unmasked Phases of Wear
|
97.5 mg/dL
Interval 87.0 to 113.5
|
97.0 mg/dL
Interval 87.0 to 113.0
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Mean Sensor Glucose Level During Masked Versus Unmasked Phases of Wear
|
103.8 mg/dL
Standard Deviation 12.3
|
104.1 mg/dL
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.expressed as median and median standard deviation
Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Peak Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear
|
263.0 mg/dL
Standard Deviation 51.9
|
256.0 mg/dL
Standard Deviation 42.3
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.The sensor glucose level range is derived from the difference between the highest sensor glucose levels minus the lowest sensor glucose level (mg/dL).
Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Sensor Glucose Level Range (Highest Sensor Glucose Minus Lowest Sensor Glucose mg/dL) During Masked Versus Unmasked Period of CGM Wear
|
221.5 mg/dL
Standard Deviation 52.6
|
209.5 mg/dL
Standard Deviation 50.4
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Nadir Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear
|
40.0 mg/dL
Standard Deviation 0.0
|
42.0 mg/dL
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Percent of Time Sensor Glucose 70-180 mg/dL During Period of CGM Wear, Masked Versus Unmasked Phase
|
90.8 Percentage of time
Standard Deviation 5.2
|
94.8 Percentage of time
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Percentage of Time Sensor Glucose Level >180 mg/dL During Period of CGM Wear, Masked Versus Unmasked Phase
|
3.1 Percentage of time
Standard Deviation 2.8
|
1.7 Percentage of time
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Percentage of Time Sensor Glucose Level >250 mg/dL During Periods of CGM Wear, Masked Versus Unmasked Phase
|
0.1 Percentage of time
Standard Deviation 0.2
|
0.1 Percentage of time
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Glycemic Variability as Measured by the Standard Deviation of Sensor Glucose Level Data During Periods of CGM Wear, Masked Versus Unmasked Phase
|
29.8 mg/dL
Standard Deviation 7.1
|
26.6 mg/dL
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Mean Coefficient of Variation of Sensor Glucose Data During Period of CGM Wear, Masked Versus Unmasked Phase
|
23.6 Integer (of variation)
Standard Deviation 5.1
|
23.0 Integer (of variation)
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Mean Amplitude of Glycemic Excursion (MAGE) of Sensor Glucose Levels During Periods of CGM Wear, Masked Versus Unmasked Phase
|
79.6 mg/dL
Standard Deviation 17.8
|
74.0 mg/dL
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.CONGA assesses glucose variability within a predetermined time window - 24 hours in this case. Calculation of this parameter is based on the assessment of the differences between glucose values measured at regular time intervals, then on the standard deviation (SD) of these differences
Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
24 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase
|
35.6 mg/dL
Standard Deviation 11.5
|
33.0 mg/dL
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
1 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase
|
35.5 mg/dL
Standard Deviation 9.4
|
33.2 mg/dL
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
2 Hours, Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase
|
36.1 mg/dL
Standard Deviation 11.1
|
36.9 mg/dL
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
4 Hours, Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase
|
38.9 mg/dL
Standard Deviation 10.3
|
37.0 mg/dL
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.Hypoglycemic events are defined as having glucose \<70 mg/dL for at least 15 minutes, ending when glucose \> the threshold. Hypoglycemic event values were normalized by dividing the number of events by the number of days of data.
Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Total Number of Hypoglycemic Events During the Masked Versus the Unmasked Phases of CGM Wear, as Defined by a Sensor Glucose <70 mg/dL, for at Least 15 Minutes
|
1.6 Number of events per period of wear
Standard Deviation 1.5
|
1.8 Number of events per period of wear
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.Hypoglycemic events are defined as having glucose \<60 mg/dL for at least 15 minutes, ending when glucose \> the threshold. Hypoglycemic event values were normalized by dividing the number of events by the number of days of data.
Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Total Number of Hypoglycemic Events Defined by a Sensor Glucose <60 mg/dL, for at Lease 15 Minutes, During the Masked Versus Unmasked CGM Phase
|
0.7 Number of events per period of wear
Standard Deviation 0.6
|
0.5 Number of events per period of wear
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.Hypoglycemic events are defined as having glucose \<54 mg/dL for at least 15 minutes, ending when glucose \> the threshold. Hypoglycemic event values were normalized by dividing the number of events by the number of days of data.
Outcome measures
| Measure |
Masked CGM Wear (Phase 1)
n=22 Participants
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=22 Participants
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Total Number of Hypoglycemic Events Defined by a Sensor Glucose <54 mg/dL, for at Least 15 Minutes, During the Masked Versus Unmasked CGM Phase
|
0.3 Number of events per period of wear
Standard Deviation 0.4
|
0.2 Number of events per period of wear
Standard Deviation 0.3
|
Adverse Events
Masked CGM Wear (Phase 1)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Unmasked CGM Wear (Phase 2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Masked CGM Wear (Phase 1)
n=25 participants at risk
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=23 participants at risk
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
General disorders
Depressive episode
|
4.0%
1/25 • Number of events 1 • For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 28 days. For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 20 days.
Study clinicians assessed participants for adverse events at all study visits.
|
0.00%
0/23 • For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 28 days. For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 20 days.
Study clinicians assessed participants for adverse events at all study visits.
|
Other adverse events
| Measure |
Masked CGM Wear (Phase 1)
n=25 participants at risk
During the first phase, participants will not be able to read the sensor glucose levels (masked).
Dexcom CGM masked: The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)).
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
Unmasked CGM Wear (Phase 2)
n=23 participants at risk
During the second phase, participants will be able to read the sensor glucose levels (unmasked). Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia requiring emergency department evaluation
|
0.00%
0/25 • For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 28 days. For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 20 days.
Study clinicians assessed participants for adverse events at all study visits.
|
4.3%
1/23 • Number of events 1 • For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 28 days. For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 20 days.
Study clinicians assessed participants for adverse events at all study visits.
|
|
Skin and subcutaneous tissue disorders
Skin irritation under Dexcom G4 sensor site
|
15.4%
2/13 • Number of events 2 • For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 28 days. For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 20 days.
Study clinicians assessed participants for adverse events at all study visits.
|
0.00%
0/13 • For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 28 days. For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 20 days.
Study clinicians assessed participants for adverse events at all study visits.
|
|
Skin and subcutaneous tissue disorders
Mild erythema under dexcom G4 sensor adhesive
|
7.7%
1/13 • Number of events 1 • For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 28 days. For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 20 days.
Study clinicians assessed participants for adverse events at all study visits.
|
0.00%
0/13 • For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 28 days. For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 20 days.
Study clinicians assessed participants for adverse events at all study visits.
|
|
Skin and subcutaneous tissue disorders
Discomfort at site of Dexcom G4 sensor
|
7.7%
1/13 • Number of events 1 • For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 28 days. For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 20 days.
Study clinicians assessed participants for adverse events at all study visits.
|
0.00%
0/13 • For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 28 days. For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 20 days.
Study clinicians assessed participants for adverse events at all study visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place