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Clinical Trial NCT00211510 (STAR1) for Type 1 Diabetes is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes (STAR1) 146 Adolescent
Clinical Trial NCT00211510 (STAR1) was an interventional study for Type 1 Diabetes that is now completed. The study started on 1 June 2005, with plans to enroll 146 participants. Led by Medtronic Diabetes, the expected completion date was 1 February 2007. The latest data from ClinicalTrials.gov was last updated on 12 June 2017.
Brief Summary
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.
Detailed Description
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 measure...Show More
Official Title
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
Conditions
Type 1 DiabetesOther Study IDs
- STAR1
- CEP 178/Z25/A2
NCT ID Number
Start Date (Actual)
2005-06
Last Update Posted
2017-06-12
Completion Date (Estimated)
2007-02
Enrollment (Estimated)
146
Study Type
Interventional
PHASE
N/A
Status
Completed
Keywords
Diabetes
Continuous Glucose Monitoring
Glycemic Control
Continuous Glucose Monitoring
Glycemic Control
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalParadigm 722 sensor augmented pump subjects will use the Paradigm 722 sensor augmented pump for infusion of insulin and continuous glucose monitoring | Paradigm 722 sensor augmented pump Subjects use the Paradigm 722 sensor augmented pump |
Active ComparatorParadigm 715 insulin pump subjects will use the Paradigm 715 insulin pump which does not include sensor augmentation for infusion of insulin | Paradigm 715 insulin pump Subjects use the Paradigm 715 insulin pump |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in A1c From Baseline to 26 Weeks | Change is defined as A1c at Week 26 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects. | Baseline and 26 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26 | Severe Hypoglycemia as defined by hypoglycemic events requiring the assistance of another person to actively administer carbohydrates, glucagon or other resuscitative actions, as reported by subject. The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 26. | Baseline and 26 weeks |
Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26 | Hypoglycemia is defined as a recorded blood glucose event \<70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 26 | Baseline and 26 weeks |
Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26 | Hyperglycemia is defined as a recorded blood glucose event \> 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 26 | Baseline and 26 weeks |
Glucose Sensor Accuracy as Measured in the 722 Group | Percent comparative sensor glucose reading to blood glucose meter in agreement within +/- 20% (Clark Error Grid zone A + zone B). | Baseline and 26 weeks |
Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups | Questionnaire evaluating subjects'potential fear of hypoglycemia events. Change assessed at Baseline and Week 26 and compared between groups. Likert scale scored with 4 being the worst and 0 being no problem. | Baseline and 26 weeks |
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Minimum Age
12 Years
Eligible Sexes
All
- 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
- Pregnant or planning pregnancy
- History of unresolved tape allergy or skin conditions
Medtronic DiabetesNo contact data.
7 Study Locations in 1 Countries
California
Children's Hospital of Los Angeles, Los Angeles, California, 90027, United States
Stanford University, Stanford, California, 94305, United States
Georgia
Atlanta Diabetes Associates, Atlanta, Georgia, 30309, United States
Massachusetts
Joslin Diabetes Center, Boston, Massachusetts, 02215, United States
New York
The Endocrine Group, Albany, New York, 12206, United States
Texas
Diabetes and Glandular Diabetes Research Associates, San Antonio, Texas, 78229, United States
Washington
University of Washington, Seattle, Washington, 98195, United States