Type 1 Diabetes Clinical Trial
— STAR1Official 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
Verified date | April 2011 |
Source | Medtronic Diabetes |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 146 |
Est. completion date | February 2007 |
Est. primary completion date | August 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Endocrine Group | Albany | New York |
United States | Atlanta Diabetes Associates | Atlanta | Georgia |
United States | Joslin Diabetes Center | Boston | Massachusetts |
United States | Children's Hospital of Los Angeles | Los Angeles | California |
United States | Diabetes and Glandular Diabetes Research Associates | San Antonio | Texas |
United States | University of Washington | Seattle | Washington |
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Medtronic Diabetes |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | Yes |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
Completed |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
Completed |
NCT02855307 -
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
|
Phase 2 | |
Completed |
NCT02750527 -
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
|