Trial Outcomes & Findings for Fast Track CSII Using a Novel Device in Young Children With Newly Diagnosed T1DM (NCT NCT00476788)
NCT ID: NCT00476788
Last Updated: 2017-04-17
Results Overview
Measure of glycemic control (A1c) over preceding 8 weeks. Normal for a patient between ages 1 and 10 years would be 7.0-8.5%.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
6.9 months (average)
Results posted on
2017-04-17
Participant Flow
Participant milestones
| Measure |
Omnipod Device
Patients will be placed on an Omnipod insulin pump
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fast Track CSII Using a Novel Device in Young Children With Newly Diagnosed T1DM
Baseline characteristics by cohort
| Measure |
Omnipod Device
n=14 Participants
Patients will be placed on an Omnipod insulin pump
|
|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
6.275 years
STANDARD_DEVIATION 2.875 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6.9 months (average)Measure of glycemic control (A1c) over preceding 8 weeks. Normal for a patient between ages 1 and 10 years would be 7.0-8.5%.
Outcome measures
| Measure |
Omnipod Device
n=11 Participants
Patients will be placed on an Omnipod insulin pump
|
|---|---|
|
Mean Glycated Hemoglobin (A1c)
|
7.6 percentage of glycated hemoglobin
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 6.9 months (average)adverse events are defined as a change from baseline
Outcome measures
| Measure |
Omnipod Device
n=11 Participants
Patients will be placed on an Omnipod insulin pump
|
|---|---|
|
Number of Reported Adverse Events
|
0 events
|
Adverse Events
Omnipod Device
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