Feasibility Study for Training Pump Naïve Subjects To Use The Paradigm® System And Evaluate Effectiveness
STAR2
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
1 other identifier
interventional
29
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2006
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 13, 2007
CompletedFirst Posted
Study publicly available on registry
September 17, 2007
CompletedResults Posted
Study results publicly available
June 10, 2011
CompletedJune 10, 2011
May 1, 2011
7 months
September 13, 2007
December 17, 2010
May 9, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change in A1C From Baseline to Week 15
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.
Baseline and 15 weeks
Secondary Outcomes (4)
Incidence of Severe Hypoglycemia Events Baseline to Week 15
Baseline and 15 weeks
Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15
Baseline and 15 weeks
Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15
Baseline and 15 weeks
Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15
Baseline and 15 weeks
Study Arms (2)
1. 722
ACTIVE COMPARATOR722 arm: MiniMed Paradigm REAL-Time System
2. Multiple Daily Injections (MDI)
NO INTERVENTIONMDI arm: Continue with currently prescribed Multiple Daily Injection therapy. No change in treatment or regime for study.
Interventions
MiniMed Paradigm 722 insulin pump The transmitter The sensor Paradigm Link Glucose Meter The ComLink
Eligibility Criteria
You may qualify if:
- Subject is between 18 - 70 years of age (inclusive)
- Subject is diagnosed with Type 1 Diabetes Mellitus as determined by the Investigator.
- Diabetes is diagnosed \> (greater or equal to) six (6) months prior to study entry.
- A1C \> 7.5% (greater than or equal to) as measured by the Central Laboratory at Screening Visit 1.
- Subject currently requires insulin administration by injection \> (greater or equal to) three (3) times daily.
- Subject is currently (over past 3 months) performing an average of four (4) blood glucose measurements per day, as determined and documented by the investigator
- Subject has been treated in the investigator's practice or in a referring endocrinologist's practice for at least 6 months prior to the study
- Subject is fluent in speaking, understanding, and reading English.
- Subject is able and willing to perform the study procedures and agrees to wear sensors at least five (5) days per week (722 Arm only) during the study period.
- Subject is able to use the study devices (722 Arm only) as labeled
- Subject has reviewed and signed the Informed consent, HIPPA Authorization, and California Experimental Subject's Bill of Rights (California only).
- Subject has the capability to upload their insulin pumps or glucose meters every two weeks; access to the Internet and specific computer system requirements are necessary to participate in the study
You may not qualify if:
- Subject is pregnant or planning to become pregnant during the course of the study.
- Subject has a history of tape allergies that have not been resolved.
- Subject self-reports any skin abnormality (i.e. psoriasis, rash, and staphylococcus infection).
- Subject is currently or within past 4 weeks participated in an investigational study (drug or device).
- Subject has a history of tape allergies that have not been resolved.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Diabetes Treatment Center, Loma Linda University
Loma Linda, California, 92354, United States
Portland Diabetes & Endocrinology
Portland, Oregon, 97210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Harold Torunsky
- Organization
- Director, Program Management, Clinical Research
Study Officials
- STUDY DIRECTOR
Scott W Lee, MD
Medtronic Diabetes
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2007
First Posted
September 17, 2007
Study Start
February 1, 2006
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
June 10, 2011
Results First Posted
June 10, 2011
Record last verified: 2011-05