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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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This is a blinded cross-over study to see if extended wear insulin infusion sets can prolong insulin infusion set wear up to 7 days in adults with Type 1 Diabetes.
This is a double blinded cross-over study. Subjects will be asked to wear infusion set either a standard infusion set or an extended wear infusion set. They will wear each infusion set twice, and the order of infusion set wear will be randomized with the first infusion set wear and then alternated over 4 weeks. By performing a cross over study using both experimental infusion sets and standard infusion sets, the investigators hope to see whether there is a benefit to using an extended wear infusion set.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protocol 1: Standard then Extended Set | Experimental | Participants will wear the control (standard) infusion set for 1 week, then switch to the experimental Extended Wear infusion set in combination with Heparin 400 IU for 1 week, then will repeat the cycle for a total of 4 weeks. |
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| Protocol 1: Extended then Standard Set | Experimental | Participants will wear the experimental Extended Wear infusion set in combination with Heparin 400 IU for 1 week, then switch to the control (standard) infusion set for 1 week, then will repeat the cycle for a total of 4 weeks. |
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| Protocol 2 (Part 1): Sequence 1 | Experimental | Participants will wear the control (standard) infusion set for 1 week, then the Extended Wear infusion set with heparin at 40 IU (week 1), 80 IU (week 2), 120 IU (week 3), and 200 IU (week 4). |
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| Protocol 2 (Part 1): Sequence 2 | Experimental | Participants will wear the Extended Wear infusion set with heparin at 40 IU (week 1), 80 IU (week 2), 120 IU (week 3), and 200 IU (week 4), then the control (standard) infusion set (week 5). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended Wear infusion set | Device | For two of the 4 weeks the Extended Wear insulin infusion set will be used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to an infusion set failure due to an occlusion | Glucose >250 mg/dL with failure of a correction dose to lower the glucose by 50 mg/dL, or ketones > or = 0.6 mg/dL with a glucose reading of >250 mg/dL (in the absence of illness), or a pump occlusion alarm | within 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| signs of infection at insulin infusion site | erythema or induration of > 1cm in diameter at injection site | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Buckingham, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
To maintain the integrity of this research study, the subject is told they may not have access to any health information developed as part of this study until it is completed.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Protocol 2 (Part 1): Sequence 3 | Experimental | Participants will wear the Extended Wear infusion set with heparin at 80 IU (week 1), 120 IU (week 2), and 200 IU (week 3), then the control (standard) infusion set (week 4), then the Extended Wear infusion set with heparin at 40 IU (week 5). |
|
| Protocol 2 (Part 1): Sequence 4 | Experimental | Participants will wear the Extended Wear infusion set with heparin at 120 IU (week 1), and 200 IU (week 2), then the control (standard) infusion set (week 3), then the Extended Wear infusion set with heparin at 40 IU (week 4), and 80 IU (week 5). |
|
| Protocol 2 (Part 1): Sequence 5 | Experimental | Participants will wear the Extended Wear infusion set with heparin at 200 IU (week 1), then the control (standard) infusion set (week 2), then the Extended Wear infusion set with heparin at 40 IU (week 3), 80 IU (week 4), and 80 IU (week 5). |
|
| Protocol 2 (Part 2): Standard then Extended Set | Experimental | Participants will wear the control (standard) infusion set for 1 week, then switch to the experimental Extended Wear infusion set in combination with Heparin 80 IU for 1 week, then will repeat the cycle for a total of 4 weeks. |
|
| Protocol 2 (Part 1): Extended then Standard Set | Experimental | Participants will wear the experimental Extended Wear infusion set in combination with Heparin 80 IU for 1 week, then switch to the control (standard) infusion set for 1 week, then will repeat the cycle for a total of 4 weeks. |
|
| Standard Infusion set | Device | For two of the 4 weeks the Standard infusion set will be used |
|
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| Heparin | Drug |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |