Trial Outcomes & Findings for Comparison of 3 Versus 6-Month Use of CGMS in Non-Insulin Using T2DM Patients (NCT NCT03067480)
NCT ID: NCT03067480
Last Updated: 2026-01-09
Results Overview
Time sensor glucose is between 70-140mg/dl during a 72 hour collection period
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
6 Months
Results posted on
2026-01-09
Participant Flow
Participant milestones
| Measure |
3-Month iPro2 Professional CGM
Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
iPro2 Professional CGM: Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
|
6-Month iPro2 Professional CGM
Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
iPro2 Professional CGM: Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
3-Month iPro2 Professional CGM
Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
iPro2 Professional CGM: Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
|
6-Month iPro2 Professional CGM
Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
iPro2 Professional CGM: Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
started insulin
|
1
|
1
|
Baseline Characteristics
Comparison of 3 Versus 6-Month Use of CGMS in Non-Insulin Using T2DM Patients
Baseline characteristics by cohort
| Measure |
3-Month iPro2 Professional CGM
n=5 Participants
Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
iPro2 Professional CGM: Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
|
6-Month iPro2 Professional CGM
n=7 Participants
Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
iPro2 Professional CGM: Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 4.8 • n=8 Participants
|
54.0 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
57.1 years
STANDARD_DEVIATION 7.4 • n=15 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=8 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=8 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=8 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
A1c
|
9.7 percent
STANDARD_DEVIATION 1.6 • n=8 Participants
|
9.6 percent
STANDARD_DEVIATION 1.2 • n=7 Participants
|
9.6 percent
STANDARD_DEVIATION 1.4 • n=15 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsTime sensor glucose is between 70-140mg/dl during a 72 hour collection period
Outcome measures
| Measure |
3-Month iPro2 Professional CGM
n=2 Participants
Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
iPro2 Professional CGM: Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
|
6-Month iPro2 Professional CGM
n=2 Participants
Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
iPro2 Professional CGM: Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
|
|---|---|---|
|
Time Spent in Target Range
|
38.5 percentage
Standard Deviation 18.5
|
50 percentage
Standard Deviation 40
|
Adverse Events
3-Month iPro2 Professional CGM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
6-Month iPro2 Professional CGM
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