Trial Outcomes & Findings for Continuous Glucose Monitor in Children With Poorly Controlled Diabetes (NCT NCT02530450)
NCT ID: NCT02530450
Last Updated: 2017-10-06
Results Overview
Recruitment status
COMPLETED
Target enrollment
30 participants
Primary outcome timeframe
0 months, 3 months and 6 months
Results posted on
2017-10-06
Participant Flow
Participant milestones
| Measure |
Group 1
Initially blinded to continuous glucose monitoring data
|
Group 2
Never blinded to continuous glucose monitoring data
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Continuous Glucose Monitor in Children With Poorly Controlled Diabetes
Baseline characteristics by cohort
| Measure |
Group 1
n=10 Participants
Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use
continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points.
|
Group 2
n=9 Participants
Never blinded to continuous glucose monitoring data
continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12 years
STANDARD_DEVIATION 3.16 • n=5 Participants
|
13 years
STANDARD_DEVIATION 3.05 • n=7 Participants
|
12.74 years
STANDARD_DEVIATION 3.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Pubertal
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 months, 3 months and 6 monthsOutcome measures
| Measure |
Group 1
n=10 Participants
Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use
continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points.
|
Group 2
n=9 Participants
Never blinded to continuous glucose monitoring data
continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points.
|
|---|---|---|
|
The Primary Outcome Measure Was Change in HgbA1c
Change between 0 mo and 6 mo
|
-1.1 HbgA1c %
Interval -2.4 to 0.0
|
-0.5 HbgA1c %
Interval -0.9 to 0.2
|
|
The Primary Outcome Measure Was Change in HgbA1c
Change between 0 mo and 3 mo
|
-0.95 HbgA1c %
Interval -1.7 to 0.7
|
-0.9 HbgA1c %
Interval -1.4 to -0.4
|
|
The Primary Outcome Measure Was Change in HgbA1c
Change between 3 mo and 6 mo
|
-0.6 HbgA1c %
Interval -0.9 to -0.1
|
-0.9 HbgA1c %
Interval -1.4 to -0.4
|
SECONDARY outcome
Timeframe: 3 months and 6 monthsOutcome measures
Outcome data not reported
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=16 participants at risk
Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use
continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points.
|
Group 2
n=14 participants at risk
Never blinded to continuous glucose monitoring data
continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pain with catheter insertion
|
18.8%
3/16
|
21.4%
3/14
|
Additional Information
Dr. Maria Rayas, Assistant Professor in Pediatric Endocrinology and Diabetes
UT Health Science Center in San Antonio
Phone: 210-567-5283
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place