Trial Outcomes & Findings for Feasibility Study for Training Pump Naïve Subjects To Use The Paradigm® System And Evaluate Effectiveness (NCT NCT00530023)
NCT ID: NCT00530023
Last Updated: 2011-06-10
Results Overview
Change in A1C measured from Baseline to week 15 will be compared. A1C measured as percent of glycated hemoglobin using a standardized assay for all subjects.
COMPLETED
PHASE4
29 participants
Baseline and 15 weeks
2011-06-10
Participant Flow
Participant milestones
| Measure |
722 Sensor Augmented Insulin Pump
722 MiniMed Paradigm REAL-Time System
|
Multiple Daily Injections (MDI)
Continue with current Multiple Daily Injection therapy
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
722 Sensor Augmented Insulin Pump
722 MiniMed Paradigm REAL-Time System
|
Multiple Daily Injections (MDI)
Continue with current Multiple Daily Injection therapy
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Feasibility Study for Training Pump Naïve Subjects To Use The Paradigm® System And Evaluate Effectiveness
Baseline characteristics by cohort
| Measure |
722 Sensor Augmented Insulin Pump
n=14 Participants
722 MiniMed Paradigm REAL-Time System
|
Multiple Daily Injections (MDI)
n=15 Participants
Continue with current Multiple Daily Injection therapy
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age Continuous
|
45.1 years
STANDARD_DEVIATION 12.59 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 13.51 • n=7 Participants
|
47.4 years
STANDARD_DEVIATION 13.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 15 weeksChange in A1C measured from Baseline to week 15 will be compared. A1C measured as percent of glycated hemoglobin using a standardized assay for all subjects.
Outcome measures
| Measure |
722 Sensor Augmented Insulin Pump
n=14 Participants
722 MiniMed Paradigm REAL-Time System
|
Multiple Daily Injections (MDI)
n=14 Participants
Continue with current Multiple Daily Injection therapy
|
|---|---|---|
|
Change in A1C From Baseline to Week 15
|
-1.7 percent glycated hemoglobin
Standard Deviation 0.96
|
-1.0 percent glycated hemoglobin
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Baseline and 15 weeksThe total number of severe hypoglycemia events, defined as episodes requiring assistance from another person (i.e., subject is unable to treat self and requires carbohydrate or glucagon or other resuscitative actions) compared between the two study arms from Baseline to Week 15.
Outcome measures
| Measure |
722 Sensor Augmented Insulin Pump
n=14 Participants
722 MiniMed Paradigm REAL-Time System
|
Multiple Daily Injections (MDI)
n=15 Participants
Continue with current Multiple Daily Injection therapy
|
|---|---|---|
|
Incidence of Severe Hypoglycemia Events Baseline to Week 15
|
0 number of events
|
1 number of events
|
SECONDARY outcome
Timeframe: Baseline and 15 weeksQuestionnaire measuring overall satisfaction with the relevant blood glucose monitoring system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response.
Outcome measures
| Measure |
722 Sensor Augmented Insulin Pump
n=14 Participants
722 MiniMed Paradigm REAL-Time System
|
Multiple Daily Injections (MDI)
n=14 Participants
Continue with current Multiple Daily Injection therapy
|
|---|---|---|
|
Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15
|
73.8 Scores on a scale
Standard Deviation 26.7
|
41.0 Scores on a scale
Standard Deviation 30.9
|
SECONDARY outcome
Timeframe: Baseline and 15 weeksQuestionnaire measuring overall satisfaction with the relevant insulin delivery system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response.
Outcome measures
| Measure |
722 Sensor Augmented Insulin Pump
n=14 Participants
722 MiniMed Paradigm REAL-Time System
|
Multiple Daily Injections (MDI)
n=14 Participants
Continue with current Multiple Daily Injection therapy
|
|---|---|---|
|
Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15
|
83.3 Scores on a scale
Standard Deviation 21.7
|
33.3 Scores on a scale
Standard Deviation 22.6
|
SECONDARY outcome
Timeframe: Baseline and 15 weeksQuestionnaire evaluating change in the subjects' fear of potential hypoglycemia events assessed Week 15 and compared between arms. Likert scale of 0 - 4 used with responses graded as the lowest number being the most acceptable and highest number the least acceptable. The questionnaire has two sections, Behavior and Worry with a maximum possible score of 60 for Behavior (15 X 4) and 72 for Worry (18 X 4). The total combined scoring of these two sections was then assessed at Baseline and Week 15 and the change from Baseline to Week 15 for each arm reported as the end of study result.
Outcome measures
| Measure |
722 Sensor Augmented Insulin Pump
n=14 Participants
722 MiniMed Paradigm REAL-Time System
|
Multiple Daily Injections (MDI)
n=14 Participants
Continue with current Multiple Daily Injection therapy
|
|---|---|---|
|
Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15
|
-10.57 Scores on a scale
Standard Deviation 17.30
|
-17.79 Scores on a scale
Standard Deviation 19.99
|
Adverse Events
722 Sensor Augmented Insulin Pump
Multiple Daily Injections (MDI)
Serious adverse events
| Measure |
722 Sensor Augmented Insulin Pump
n=14 participants at risk
722 MiniMed Paradigm REAL-Time System
|
Multiple Daily Injections (MDI)
n=15 participants at risk
Continue with current Multiple Daily Injection therapy
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
7.1%
1/14 • Number of events 1 • 15 weeks
Subject workbooks assessed at each visit. Discussion regarding SAE or AEs at each visit with reminders to call study personnel if SAE occured.
|
0.00%
0/15 • 15 weeks
Subject workbooks assessed at each visit. Discussion regarding SAE or AEs at each visit with reminders to call study personnel if SAE occured.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/14 • 15 weeks
Subject workbooks assessed at each visit. Discussion regarding SAE or AEs at each visit with reminders to call study personnel if SAE occured.
|
6.7%
1/15 • Number of events 1 • 15 weeks
Subject workbooks assessed at each visit. Discussion regarding SAE or AEs at each visit with reminders to call study personnel if SAE occured.
|
|
Gastrointestinal disorders
Food Poisening
|
0.00%
0/14 • 15 weeks
Subject workbooks assessed at each visit. Discussion regarding SAE or AEs at each visit with reminders to call study personnel if SAE occured.
|
6.7%
1/15 • Number of events 1 • 15 weeks
Subject workbooks assessed at each visit. Discussion regarding SAE or AEs at each visit with reminders to call study personnel if SAE occured.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/14 • 15 weeks
Subject workbooks assessed at each visit. Discussion regarding SAE or AEs at each visit with reminders to call study personnel if SAE occured.
|
6.7%
1/15 • Number of events 2 • 15 weeks
Subject workbooks assessed at each visit. Discussion regarding SAE or AEs at each visit with reminders to call study personnel if SAE occured.
|
Other adverse events
Adverse event data not reported
Additional Information
Harold Torunsky
Director, Program Management, Clinical Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60