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Trial record 2 of 4 for:    "MiniMed Paradigm REAL-Time System"

Feasibility Study for Training Pump Naïve Subjects To Use The Paradigm® System And Evaluate Effectiveness (STAR2)

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ClinicalTrials.gov Identifier: NCT00530023
Recruitment Status : Completed
First Posted : September 17, 2007
Results First Posted : June 10, 2011
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
Medtronic Diabetes

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Intervention Device: MiniMed Paradigm REAL-Time System
Enrollment 29

Recruitment Details  
Pre-assignment Details  
Arm/Group Title 722 Sensor Augmented Insulin Pump Multiple Daily Injections (MDI)
Hide Arm/Group Description 722 MiniMed Paradigm REAL-Time System Continue with current Multiple Daily Injection therapy
Period Title: Overall Study
Started 14 15
Completed 14 14
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title 722 Sensor Augmented Insulin Pump Multiple Daily Injections (MDI) Total
Hide Arm/Group Description 722 MiniMed Paradigm REAL-Time System Continue with current Multiple Daily Injection therapy Total of all reporting groups
Overall Number of Baseline Participants 14 15 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
  92.9%
11
  73.3%
24
  82.8%
>=65 years
1
   7.1%
4
  26.7%
5
  17.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 15 participants 29 participants
45.1  (12.59) 49.7  (13.51) 47.4  (13.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
Female
6
  42.9%
10
  66.7%
16
  55.2%
Male
8
  57.1%
5
  33.3%
13
  44.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 15 participants 29 participants
14 15 29
1.Primary Outcome
Title Change in A1C From Baseline to Week 15
Hide Description 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.
Time Frame Baseline and 15 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 722 Sensor Augmented Insulin Pump Multiple Daily Injections (MDI)
Hide Arm/Group Description:
722 MiniMed Paradigm REAL-Time System
Continue with current Multiple Daily Injection therapy
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: percent glycated hemoglobin
-1.7  (0.96) -1.0  (0.97)
2.Secondary Outcome
Title Incidence of Severe Hypoglycemia Events Baseline to Week 15
Hide Description The 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.
Time Frame Baseline and 15 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 722 Sensor Augmented Insulin Pump Multiple Daily Injections (MDI)
Hide Arm/Group Description:
722 MiniMed Paradigm REAL-Time System
Continue with current Multiple Daily Injection therapy
Overall Number of Participants Analyzed 14 15
Measure Type: Number
Unit of Measure: number of events
0 1
3.Secondary Outcome
Title Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15
Hide Description Questionnaire 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.
Time Frame Baseline and 15 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 722 Sensor Augmented Insulin Pump Multiple Daily Injections (MDI)
Hide Arm/Group Description:
722 MiniMed Paradigm REAL-Time System
Continue with current Multiple Daily Injection therapy
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
73.8  (26.7) 41.0  (30.9)
4.Secondary Outcome
Title Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15
Hide Description Questionnaire 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.
Time Frame Baseline and 15 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 722 Sensor Augmented Insulin Pump Multiple Daily Injections (MDI)
Hide Arm/Group Description:
722 MiniMed Paradigm REAL-Time System
Continue with current Multiple Daily Injection therapy
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
83.3  (21.7) 33.3  (22.6)
5.Secondary Outcome
Title Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15
Hide Description Questionnaire 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.
Time Frame Baseline and 15 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 722 Sensor Augmented Insulin Pump Multiple Daily Injections (MDI)
Hide Arm/Group Description:
722 MiniMed Paradigm REAL-Time System
Continue with current Multiple Daily Injection therapy
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-10.57  (17.30) -17.79  (19.99)
Time Frame 15 weeks
Adverse Event Reporting Description Subject workbooks assessed at each visit. Discussion regarding SAE or AEs at each visit with reminders to call study personnel if SAE occured.
 
Arm/Group Title 722 Sensor Augmented Insulin Pump Multiple Daily Injections (MDI)
Hide Arm/Group Description 722 MiniMed Paradigm REAL-Time System Continue with current Multiple Daily Injection therapy
All-Cause Mortality
722 Sensor Augmented Insulin Pump Multiple Daily Injections (MDI)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
722 Sensor Augmented Insulin Pump Multiple Daily Injections (MDI)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      3/15 (20.00%)    
Gastrointestinal disorders     
Food Poisening * 1  0/14 (0.00%)  0 1/15 (6.67%)  1
Infections and infestations     
Appendicitis * 1  1/14 (7.14%)  1 0/15 (0.00%)  0
Metabolism and nutrition disorders     
Diabetic Ketoacidosis  1  0/14 (0.00%)  0 1/15 (6.67%)  1
Hypoglycemia  1  0/14 (0.00%)  0 1/15 (6.67%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 8.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
722 Sensor Augmented Insulin Pump Multiple Daily Injections (MDI)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/15 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Harold Torunsky
Organization: Director, Program Management, Clinical Research
Phone: 8185765445
Responsible Party: Scott Lee, MD/ Director, Medical Affairs, Medtronic
ClinicalTrials.gov Identifier: NCT00530023     History of Changes
Other Study ID Numbers: CEP195/Z25
First Submitted: September 13, 2007
First Posted: September 17, 2007
Results First Submitted: December 17, 2010
Results First Posted: June 10, 2011
Last Update Posted: June 10, 2011