Feasibility Study for Training Pump Naïve Subjects To Use The Paradigm® System And Evaluate Effectiveness (STAR2)
Feasibility study to compare the effectiveness of the Paradigm Sensor Augmented System versus subjects continuing to administer insulin in multiple dose injections. Evaluate the educational materials and time required for training subjects naïve to continuous subcutaneous insulin infusion (CSII) to use the Paradigm 722 REAL Time System in preparation for a large multi-center clinical trial
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study To Identify Effective Methods Of Training Pump Naïve Subjects To Use The Paradigm® 722 System And To Describe Clinical Effectiveness Compared To Subjects Continuing With Multiple Dose Injections (MDI) of Insulin|
- Change in A1C From Baseline to Week 15 [ Time Frame: Baseline and 15 weeks ] [ Designated as safety issue: No ]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.
- Incidence of Severe Hypoglycemia Events Baseline to Week 15 [ Time Frame: Baseline and 15 weeks ] [ Designated as safety issue: Yes ]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.
- Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15 [ Time Frame: Baseline and 15 weeks ] [ Designated as safety issue: No ]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.
- Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15 [ Time Frame: Baseline and 15 weeks ] [ Designated as safety issue: No ]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.
- Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15 [ Time Frame: Baseline and 15 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2006|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
Active Comparator: 1. 722
722 arm: MiniMed Paradigm REAL-Time System
Device: MiniMed Paradigm REAL-Time System
MiniMed Paradigm 722 insulin pump The transmitter The sensor Paradigm Link Glucose Meter The ComLink
No Intervention: 2. Multiple Daily Injections (MDI)
MDI arm: Continue with currently prescribed Multiple Daily Injection therapy. No change in treatment or regime for study.
Many subjects with Type 1 diabetes continue to manage their disease utilizing multiple daily injections, but despite frequent blood glucose checks, are unable to control their glycemic variability or lower their A1C levels. The MiniMed Paradigm REAL-Time System transmits sensor glucose values to the insulin pump every 5 minutes, allowing users to view their current glucose values as well as glycemic excursions and trends over a 24-hour period. The System will also alert users of high and low glucose levels, allowing subjects and their clinicians to make carefully monitored modifications to therapy. Additionally, data can be uploaded from the monitor into a personal computer, allowing the subject and clinician to see a complete picture of trends over time.
Subjects learning this technology would require a new approach to training if they were to master operation of an insulin pump, make effective use of the sensor technology and understand the complete picture provided by the software component. Subjects will be trained to first use the insulin pump, add the sensor and then utilize the software and the effectiveness of the training methods and timing will be measured using questionnaires designed to evaluate understanding of the device, Self Efficacy and User Acceptance. The group wearing the System will also be compared to subjects that continue on their current MDI therapy over a 15-week time period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530023
|United States, California|
|Diabetes Treatment Center, Loma Linda University|
|Loma Linda, California, United States, 92354|
|United States, Oregon|
|Portland Diabetes & Endocrinology|
|Portland, Oregon, United States, 97210|
|Study Director:||Scott W Lee, MD||Medtronic Diabetes|