Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Continuous Subcutaneous Insulin Infusion (CSII) via insulin pump therapy has been shown to improve quality of life and glucose control in many patients with diabetes opting for this treatment modality. Despite significant innovation and advancement in pump technology, insulin infusion sets have been an area where innovation has been significantly lacking with no clinical studies performed prior to product launches.
BD has developed a subcutaneous infusion set with FlowSmartâ„¢ Technology designed to address patient comfort, insulin delivery and flow interruptions. According to preliminary animal and clinical studies, this technology results in lower infusion pressure indicating more consistent insulin delivery.
The FlowSmart infusion set has been previously tested in prototype form with healthy non-diabetic subjects with the sets inserted by nurses, and with CSII-using patients who self-inserted the FlowSmart infusion set in a clinical research setting.
The purpose of this study is to determine if insulin pump users prefer using the BD FlowSmart infusion set compared to their current set with respect to insertion pain and wear comfort.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FlowSmart Infusion set, then current set | Subjects will use the FlowSmart Infusion Set for a period of 9 to 11 days, then switch to their current infusion set for another period of 9 to 11 days. Subjects must use at least 3 sets during each Study Period then - Subjects will use their current infusion set for a period of 9 to 11 days, then switch to the FlowSmart infusion set for another period of 9 to 11 days. Subjects must use at least 3 sets during each Study Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FlowSmart Infusion Set | Device | Use of set for subcutaneous insulin infusion, with set change every three days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparative Infusion Set Insertion Pain | At the study visit after completing both study periods (Visit 3), subjects will use a 15 cm Visual Analog Scale (VAS) to indicate which insertion set was less painful to insert, the BD Flowsmart or their current infusion set. Effects of infusion set type will be tested for statistical significance using linear mixed models adjusting for the effect of subject, study site and period. The model will be used to generate a two-sided 95% confidence interval for the adjusted average pain rating using a multiple comparison approach. | Comparative pain measure assessed at the end of Study Period 2, after 9-11 days use of each infusion set type |
| Comparative Infusion Set Wear Comfort | At the study visit after completing both study periods (Visit 3), subjects will use a 15 cm Visual Analog Scale (VAS) to indicate which set was more comfortable to wear, the BD FlowSmart or their current infusion set. Only if reduced Pain (outcome 1) for FlowSmart if achieved will wear comfort be further analyzed. Effects of infusion set type will be tested for statistical significance using linear mixed models adjusting for the effect of subject, study site and period. The model will be used to generate a two-sided 95% confidence interval for the adjusted average comfort rating using a multiple comparison approach. | Comparative pain measure assessed at the end of Study Period 2, after 9-11 days use of each infusion set type |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Infusion Set Preference | At the study visit after completing both study periods (Visit 3), subjects will use a 15 cm Visual Analog Scale (VAS) to indicate their preference for the BD Flowsmart compared to their current infusion set based on their recent experience. Effects of infusion set type will be tested for statistical significance using linear mixed models adjusting for the effect of subject, study site and period. The model will be used to generate a two-sided 95% confidence interval for the adjusted preference rating using a multiple comparison approach. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Approximately 75 subjects with type 1 diabetes currently on CSII will participate in the study
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laurence Hirsch, MD | Becton Dickinson, World Wide VP Diabetes Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute Inc. | Escondido | California | 92025 | United States | ||
| Atlanta Diabetes Associates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Current Infusion Set | Device | Use of set for subcutaneous insulin infusion, with set change every three days. |
|
| Assessed at the end of Study Period 2, after 9-11 days use of each infusion set type |
| Atlanta |
| Georgia |
| 30318 |
| United States |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
| TKL Research | Fair Lawn | New Jersey | 07410 | United States |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |