Trial Outcomes & Findings for Prospective Study of the Impact of Insulin Pump Therapy in Young Children With Type 1 Diabetes (NCT NCT00727220)
NCT ID: NCT00727220
Last Updated: 2017-05-19
Results Overview
Recruitment status
COMPLETED
Target enrollment
42 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2017-05-19
Participant Flow
Participant milestones
| Measure |
Insulin Pump Therapy
|
Insulin Injections
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Study of the Impact of Insulin Pump Therapy in Young Children With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Insulin Pump Therapy
n=21 Participants
|
Insulin Injections
n=21 Participants
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
3.8 years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
3.7 years
STANDARD_DEVIATION 0.7 • n=7 Participants
|
3.8 years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsOutcome measures
| Measure |
Insulin Pump Therapy
n=20 Participants
|
Insulin Injections
n=17 Participants
|
|---|---|---|
|
Change in HgBA1c
|
8.5 percentage of glycosylated hemoglobin
Standard Deviation 0.6
|
8.7 percentage of glycosylated hemoglobin
Standard Deviation 0.7
|
Adverse Events
Insulin Pump Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Insulin Injections
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