Trial Outcomes & Findings for Patient and Provider Glucose Reporting Preferences Ambulatory Glucose Profile (AGP) (NCT NCT02074384)
NCT ID: NCT02074384
Last Updated: 2016-03-28
Results Overview
Patients will use either SMBG or CGM for a two week period following their screening visit. At the end of the two week period they will return to the study site to download their device and have an AGP report printed. They will then complete a preference and utility survey.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
161 participants
Primary outcome timeframe
At the end of the two week SMBG or CGM period
Results posted on
2016-03-28
Participant Flow
Participant milestones
| Measure |
Continuous Glucose Monitoring
Participants will wear Continuous Glucose Monitoring for two weeks.
Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle.
|
Self Monitoring Blood Glucose
Participants will self test for two weeks.
Self Monitoring Blood Glucose: Participants will use their own SMBG device.
|
Clinicians
Clinicians completing study AGP visits.
|
|---|---|---|---|
|
Overall Study
STARTED
|
74
|
70
|
17
|
|
Overall Study
COMPLETED
|
74
|
70
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient and Provider Glucose Reporting Preferences Ambulatory Glucose Profile (AGP)
Baseline characteristics by cohort
| Measure |
Continuous Glucose Monitoring
n=74 Participants
Participants will wear Continuous Glucose Monitoring for two weeks.
Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle.
|
Self Monitoring Blood Glucose
n=70 Participants
Participants will self test for two weeks.
Self Monitoring Blood Glucose: Participants will use their own SMBG device.
|
Clinicians
n=17 Participants
Clinicians completing the study visits.
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
40 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
24.0 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
28.8 years
STANDARD_DEVIATION 18.7 • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
26.4 years
STANDARD_DEVIATION 16.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=5 Participants
|
70 participants
n=7 Participants
|
17 participants
n=5 Participants
|
161 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At the end of the two week SMBG or CGM periodPatients will use either SMBG or CGM for a two week period following their screening visit. At the end of the two week period they will return to the study site to download their device and have an AGP report printed. They will then complete a preference and utility survey.
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=70 Participants
Participants will wear Continuous Glucose Monitoring for two weeks.
Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle.
|
Self Monitoring Blood Glucose
n=70 Participants
Participants will self test for two weeks.
Self Monitoring Blood Glucose: Participants will use their own SMBG device.
|
Clinicians
n=17 Participants
Clinicians completing the study visits.
|
|---|---|---|---|
|
Portion of Study Participants Reporting Greater Utility From AGP vs. Traditional Glucose Data Reports
|
35 participants
|
29 participants
|
10 participants
|
Adverse Events
Continuous Glucose Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self Monitoring Blood Glucose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinicians
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