Trial Outcomes & Findings for Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy (NCT NCT00574405)
NCT ID: NCT00574405
Last Updated: 2017-09-13
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
12 months
Results posted on
2017-09-13
Participant Flow
104 children with T1D were screened between 04/05-02/09; 64 declined to participate; 16 did not meet inclusion/exclusion criteria. 24 subjects (12 per group) were enrolled. 1 subject in each group withdrew after initial randomization. Of the remaining 22, 1 completed the 9-mo visit, 1 completed the 6-mo visit, and 1 completed the 1-mo visit.
One subject in each group withdrew from further participation after initial randomization, possibly because of dissatisfaction with the assigned mode of treatment.
Participant milestones
| Measure |
Multiple Daily Injection Therapy
Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
|
Insulin Pump Therapy, Started at Diagnosis.
Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Multiple Daily Injection Therapy
Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
|
Insulin Pump Therapy, Started at Diagnosis.
Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy
Baseline characteristics by cohort
| Measure |
Multiple Daily Injection Therapy
n=12 Participants
Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
|
Insulin Pump Therapy, Started at Diagnosis.
n=12 Participants
Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 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
|
12.1 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
12.1 years
STANDARD_DEVIATION 3.6 • n=7 Participants
|
12.1 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Per protocol
Outcome measures
| Measure |
Multiple Daily Injection Therapy
n=9 Participants
Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
|
Insulin Pump Therapy, Started at Diagnosis.
n=10 Participants
Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
|
|---|---|---|
|
Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.
|
1.8 ng/mL
Standard Deviation 1.4
|
3.1 ng/mL
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
Adverse Events
Multiple Daily Injection Therapy
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Insulin Pump Therapy, Started at Diagnosis.
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Multiple Daily Injection Therapy
n=12 participants at risk
Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
|
Insulin Pump Therapy, Started at Diagnosis.
n=12 participants at risk
Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
|
|---|---|---|
|
Renal and urinary disorders
Hospitilized for treatment of Urinary tract infection
|
0.00%
0/12 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Multiple Daily Injection Therapy
n=12 participants at risk
Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
|
Insulin Pump Therapy, Started at Diagnosis.
n=12 participants at risk
Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain/constipation
|
25.0%
3/12 • Number of events 3 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
8.3%
1/12 • Number of events 1 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Pump malfunction
|
0.00%
0/12 • 12 months
|
33.3%
4/12 • Number of events 4 • 12 months
|
|
Infections and infestations
Infections
|
58.3%
7/12 • Number of events 13 • 12 months
|
41.7%
5/12 • Number of events 10 • 12 months
|
|
Injury, poisoning and procedural complications
Injury
|
25.0%
3/12 • Number of events 3 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
pharyngitis
|
25.0%
3/12 • Number of events 3 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Eye disorders
Vision change
|
16.7%
2/12 • Number of events 3 • 12 months
|
0.00%
0/12 • 12 months
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
8.3%
1/12 • Number of events 3 • 12 months
|
0.00%
0/12 • 12 months
|
Additional Information
Kathryn Thrailkill, MD
Arkansas Children's Hospital Research Institute
Phone: 501-364-1430
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60