- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00211510
Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes (STAR1)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90027
- Children's Hospital of Los Angeles
-
Stanford, California, United States, 94305
- Stanford University
-
-
Georgia
-
Atlanta, Georgia, United States, 30309
- Atlanta Diabetes Associates
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Joslin Diabetes Center
-
-
New York
-
Albany, New York, United States, 12206
- The Endocrine Group
-
-
Texas
-
San Antonio, Texas, United States, 78229
- Diabetes and Glandular Diabetes Research Associates
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Paradigm 722 sensor augmented pump
subjects will use the Paradigm 722 sensor augmented pump for infusion of insulin and continuous glucose monitoring
|
Subjects use the Paradigm 722 sensor augmented pump
Other Names:
|
Active Comparator: Paradigm 715 insulin pump
subjects will use the Paradigm 715 insulin pump which does not include sensor augmentation for infusion of insulin
|
Subjects use the Paradigm 715 insulin pump
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in A1c From Baseline to 26 Weeks
Time Frame: Baseline and 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26
Time Frame: Baseline and 26 weeks
|
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
Time Frame: Baseline and 26 weeks
|
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
Time Frame: Baseline and 26 weeks
|
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
Time Frame: Baseline and 26 weeks
|
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
Time Frame: Baseline and 26 weeks
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP 178/Z25/A2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 1 Diabetes
-
Poznan University of Medical SciencesUnknownDiabetes Mellitus Type 1 | Remission of Type 1 Diabetes | Chronic Complications of DiabetesPoland
-
Eledon PharmaceuticalsWithdrawnBrittle Type 1 Diabetes MellitusUnited States
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Hoffmann-La RocheCompletedType 2 Diabetes, Type 1 DiabetesAustria, United Kingdom
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
NYU Langone HealthNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
Rabin Medical CenterDreaMed DiabetesRecruiting
Clinical Trials on Paradigm 722 sensor augmented pump
-
Medtronic DiabetesCompletedDiabetes Mellitus, Type 1Netherlands, Slovenia, Denmark, Austria, Italy, Luxembourg, Spain
-
Medtronic DiabetesCompletedType 1 DiabetesUnited States
-
Medtronic DiabetesCompleted
-
University of AlbertaCompleted
-
Sansum Diabetes Research InstituteMayo Clinic; Harvard UniversityCompletedType 1 DiabetesUnited States
-
Bruce A. BuckinghamCompletedType 1 Diabetes Mellitus | Autoimmune Diabetes | Juvenile-Onset Diabetes | Diabetes, Mellitus, Type 1United States
-
Steen AndersenMedtronicCompletedType 1 Diabetes MellitusDenmark
-
Johns Hopkins Bloomberg School of Public HealthNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetic GastroparesisUnited States
-
University of VirginiaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes MellitusUnited States, Italy
-
University of Ljubljana, Faculty of MedicineCompletedType 1 Diabetes MellitusSlovenia