Ellen
03-09-2006, 01:16 PM
http://www.clinicaltrials.gov/ct/show/NCT00211510;jsessionid=E6D7F606C7251 (http://www.clinicaltrials.gov/ct/show/NCT00211510;jsessionid=E6D7F606C7251)
Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes
This study is currently recruiting patients.
Verified by Medtronic Diabetes September 2005
Sponsored by: Medtronic Diabetes
Information provided by: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT00211510
Purpose
The purpose of this study is to determine whether Type 1 Diabetic subjects using the Paradigm 722 System, which is a glucose sensor-augmented insulin pump, can improve glycemic control when compared to subjects using the Paradigm 715 insulin pump only.
Condition Intervention Phase
Type 1 Diabetes
Device: Paradigm 722 Sensor-augmented pump
Phase III
MedlinePlus related topics: Diabetes Type 1
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: "The Seven Center Study" - Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes: A Multi-Center, Randomized Controlled Trial
Further study details as provided by Medtronic Diabetes:
Primary Outcomes: Average decrease in A1c from baseline to end of Study Phase (26 weeks) for subjects in the "722 Group" is greater than that for subjects in the "Control (715) Group".
Secondary Outcomes: Incidence and frequency of severe hypoglycemia; Measure of glycemic instability; Glucose sensor accuracy; User Acceptance (QoL + User Eval); Severe adverse events and device-related adverse events
Expected Total Enrollment: 140
Study start: June 2005
Glycemic control remains a significant challenge for both adult and adolescent Type 1 diabetics. Continuous Glucose Monitoring (CGMS) is currently used by clinicians to record continuous, retrospective glucose measurements which aid in identification of glycemic excursion patterns. This data is then used to make therapy change recommendations for the future. The Paradigm 722 System transmits real-time glucose measurements to the insulin pump every 5 minutes, allowing users to view their current glucose values, as well as to review glycemic excursions and trends over a 24-hour period. This System will alert users to high and low glucose levels, and will allow subjects and their clinicians to treat to a therapeutic target HbA1c under monitored conditions.
Subjects wearing the Paradigm 722 System will be compared to subjects wearing the Paradigm 715 Insulin Pump over a 6 month period to evaluate changes in glycemic control (HbA1c).
Eligibility
Ages Eligible for Study: 12 Years - 80 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
Age 12 - 80 years
Type 1 Diabetes Mellitus diagnosed at least 1 year ago
Using insulin infusion pump for past 6 months minimum
Performing minimum 4 blood glucose tests per day
Agree to treat to A1c targets
Read and understand English
Exclusion Criteria:
Pregnant or planning pregnancy
History of unresolved tape allergy or skin conditions
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00211510
California
Stanford University, Stanford, California, 94305, United States; Recruiting
Bruce A. Buckingham, MD 650-723-5791
Bruce A. Buckingham, MD, Principal Investigator
Children's Hospital of Los Angeles, Los Angeles, California, 90027, United States; Recruiting
Mary Halvorson, RN 323-669-4606
Francine R. Kaufman, MD, Principal Investigator
Georgia
Atlanta Diabetes Associates, Atlanta, Georgia, 30309, United States; Recruiting
Bruce Bode, MD 404-355-4393
Bruce W. Bode, MD, Principal Investigator
Massachusetts
Joslin Diabetes Center, Boston, Massachusetts, 02215, United States; Recruiting
Howard A. Wolpert, MD 617-732-2665
Howard A. Wolpert, MD, Principal Investigator
New York
The Endocrine Group, Albany, New York, 12206, United States; Recruiting
Jill Ableseth, MD 518-489-4704
Jill Abelseth, MD, Principal Investigator
Texas
Diabetes and Glandular Diabetes Research Associates, San Antonio, Texas, 78229, United States; Recruiting
Sherwyn L Schwartz, MD 210-614-8612
Sherwyn L Schwartz, MD, Principal Investigator
Jerome Fischer, MD, Sub-Investigator
Washington
University of Washington, Seattle, Washington, 98195, United States; Recruiting
Irl B. Hirsch, MD 206-598-4882
Irl B. Hirsch, MD, Principal Investigator
More Information
Study ID Numbers: CEP 178/Z25/A2
Last Updated: December 8, 2005
Record first received: September 12, 2005
ClinicalTrials.gov Identifier: NCT00211510
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-03-09
Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes
This study is currently recruiting patients.
Verified by Medtronic Diabetes September 2005
Sponsored by: Medtronic Diabetes
Information provided by: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT00211510
Purpose
The purpose of this study is to determine whether Type 1 Diabetic subjects using the Paradigm 722 System, which is a glucose sensor-augmented insulin pump, can improve glycemic control when compared to subjects using the Paradigm 715 insulin pump only.
Condition Intervention Phase
Type 1 Diabetes
Device: Paradigm 722 Sensor-augmented pump
Phase III
MedlinePlus related topics: Diabetes Type 1
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: "The Seven Center Study" - Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes: A Multi-Center, Randomized Controlled Trial
Further study details as provided by Medtronic Diabetes:
Primary Outcomes: Average decrease in A1c from baseline to end of Study Phase (26 weeks) for subjects in the "722 Group" is greater than that for subjects in the "Control (715) Group".
Secondary Outcomes: Incidence and frequency of severe hypoglycemia; Measure of glycemic instability; Glucose sensor accuracy; User Acceptance (QoL + User Eval); Severe adverse events and device-related adverse events
Expected Total Enrollment: 140
Study start: June 2005
Glycemic control remains a significant challenge for both adult and adolescent Type 1 diabetics. Continuous Glucose Monitoring (CGMS) is currently used by clinicians to record continuous, retrospective glucose measurements which aid in identification of glycemic excursion patterns. This data is then used to make therapy change recommendations for the future. The Paradigm 722 System transmits real-time glucose measurements to the insulin pump every 5 minutes, allowing users to view their current glucose values, as well as to review glycemic excursions and trends over a 24-hour period. This System will alert users to high and low glucose levels, and will allow subjects and their clinicians to treat to a therapeutic target HbA1c under monitored conditions.
Subjects wearing the Paradigm 722 System will be compared to subjects wearing the Paradigm 715 Insulin Pump over a 6 month period to evaluate changes in glycemic control (HbA1c).
Eligibility
Ages Eligible for Study: 12 Years - 80 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
Age 12 - 80 years
Type 1 Diabetes Mellitus diagnosed at least 1 year ago
Using insulin infusion pump for past 6 months minimum
Performing minimum 4 blood glucose tests per day
Agree to treat to A1c targets
Read and understand English
Exclusion Criteria:
Pregnant or planning pregnancy
History of unresolved tape allergy or skin conditions
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00211510
California
Stanford University, Stanford, California, 94305, United States; Recruiting
Bruce A. Buckingham, MD 650-723-5791
Bruce A. Buckingham, MD, Principal Investigator
Children's Hospital of Los Angeles, Los Angeles, California, 90027, United States; Recruiting
Mary Halvorson, RN 323-669-4606
Francine R. Kaufman, MD, Principal Investigator
Georgia
Atlanta Diabetes Associates, Atlanta, Georgia, 30309, United States; Recruiting
Bruce Bode, MD 404-355-4393
Bruce W. Bode, MD, Principal Investigator
Massachusetts
Joslin Diabetes Center, Boston, Massachusetts, 02215, United States; Recruiting
Howard A. Wolpert, MD 617-732-2665
Howard A. Wolpert, MD, Principal Investigator
New York
The Endocrine Group, Albany, New York, 12206, United States; Recruiting
Jill Ableseth, MD 518-489-4704
Jill Abelseth, MD, Principal Investigator
Texas
Diabetes and Glandular Diabetes Research Associates, San Antonio, Texas, 78229, United States; Recruiting
Sherwyn L Schwartz, MD 210-614-8612
Sherwyn L Schwartz, MD, Principal Investigator
Jerome Fischer, MD, Sub-Investigator
Washington
University of Washington, Seattle, Washington, 98195, United States; Recruiting
Irl B. Hirsch, MD 206-598-4882
Irl B. Hirsch, MD, Principal Investigator
More Information
Study ID Numbers: CEP 178/Z25/A2
Last Updated: December 8, 2005
Record first received: September 12, 2005
ClinicalTrials.gov Identifier: NCT00211510
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-03-09