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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paradigm 722 sensor augmented pump | Experimental | subjects will use the Paradigm 722 sensor augmented pump for infusion of insulin and continuous glucose monitoring |
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| Paradigm 715 insulin pump | Active Comparator | subjects will use the Paradigm 715 insulin pump which does not include sensor augmentation for infusion of insulin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paradigm 722 sensor augmented pump | Device | Subjects use the Paradigm 722 sensor augmented pump |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott W Lee, MD | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| Stanford University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paradigm 722 Sensor Augmented Pump | subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring |
| FG001 | Paradigm 715 Insulin Pump |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Paradigm 715 insulin pump | Device | Subjects use the Paradigm 715 insulin pump |
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| 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 |
| Stanford |
| California |
| 94305 |
| United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30309 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| The Endocrine Group | Albany | New York | 12206 | United States |
| Diabetes and Glandular Diabetes Research Associates | San Antonio | Texas | 78229 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
subjects with use the Paradigm 715 insulin pump for insulin infusion
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paradigm 722 Sensor Augmented Pump | subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring |
| BG001 | Paradigm 715 Insulin Pump | subjects will use the Paradigm 715 insulin pump for insulin infusion |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Percent glycated hemoglobin | Baseline and 26 weeks |
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| 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. | Posted | Number | hypoglycemic events | Baseline and 26 weeks |
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| 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 | Posted | Mean | Standard Deviation | mmol/dl*min | Baseline and 26 weeks |
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| 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 | Posted | Mean | Standard Deviation | mmol/dl*min | Baseline and 26 weeks |
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| 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). | Posted | Number | percent of agreement | Baseline and 26 weeks |
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| 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 26 weeks |
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Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed.
Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paradigm 722 Sensor Augmented Pump | subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring | 14 | 72 | 25 | 72 | ||
| EG001 | Paradigm 715 Insulin Pump | subjects will use the Paradigm 715 insulin pump for insulin infusion | 8 | 74 | 7 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Hypoglycemia | Endocrine disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Diabetic Ketoacidosis | Endocrine disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Skin abscess | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA (8.0) | Systematic Assessment |
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| anaphylactic reaction | Immune system disorders | MedDRA (8.0) | Systematic Assessment |
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| scoliosis | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
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| Puncture wound | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhage | Vascular disorders | MedDRA (8.0) | Non-systematic Assessment | Bleeding at sensor insertion site |
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| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Shin, PhD, MBA | Medtronic, Inc | 818 576 4019 | john.shin@medtronic.com |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| >=65 years |
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| Male |
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