Evaluation of Extended Infusion Set Wear Using Medtronic Extended Wear Sof-set Infusion Set

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Extended Infusion Set Wear Using the Medtronic Extended Wear Sof-set Infusion Set

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Extended Wear infusion set
* Device: Standard Infusion set
* Drug: Heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 12 months The diagnosis of type 1 diabetes is based on the investigator's judgment; C-peptide level and antibody determinations are not needed. Age 18 to 55 years Hemoglobin A1c level less than or equal to 8.5% Willing to use Novolog insulin while they are participating in the study Total daily insulin dose is at least 0.3 units/kg/day For females, not currently known to be pregnant An understanding of and willingness to follow the protocol and sign the informed consent Willingness to wear the experimental insulin infusion sets throughout the study Must be able to understand spoken and written English Exclusion Criteria: Diabetic ketoacidosis in the past 3 months blood urea nitrogen (BUN), Creatinine, or liver function test (ALT or AST) more than three times the upper limit of normal, or thrombocytopenia Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment Pregnant or lactating females Known tape allergies Current treatment for a seizure disorder Cystic fibrosis Active infection A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples: Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian) Presence of a known adrenal disorder If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study Abuse of alcohol Dialysis for renal failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protocol 1: Standard then Extended Set<br>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. | Device: Extended Wear infusion set<br>* For two of the 4 weeks the Extended Wear insulin infusion set will be used.<br>Device: Standard Infusion set<br>* For two of the 4 weeks the Standard infusion set will be used<br>* Other names: Minimed;Drug: Heparin<br> <br> |
| Experimental: Protocol 1: Extended then Standard Set<br>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. | Device: Extended Wear infusion set<br>* For two of the 4 weeks the Extended Wear insulin infusion set will be used.<br>Device: Standard Infusion set<br>* For two of the 4 weeks the Standard infusion set will be used<br>* Other names: Minimed;Drug: Heparin<br> <br> |
| Experimental: Protocol 2 (Part 1): Sequence 1<br>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). | Device: Extended Wear infusion set<br>* For two of the 4 weeks the Extended Wear insulin infusion set will be used.<br>Device: Standard Infusion set<br>* For two of the 4 weeks the Standard infusion set will be used<br>* Other names: Minimed;Drug: Heparin<br> <br> |
| Experimental: Protocol 2 (Part 1): Sequence 2<br>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). | Device: Extended Wear infusion set<br>* For two of the 4 weeks the Extended Wear insulin infusion set will be used.<br>Device: Standard Infusion set<br>* For two of the 4 weeks the Standard infusion set will be used<br>* Other names: Minimed;Drug: Heparin<br> <br> |
| Experimental: Protocol 2 (Part 1): Sequence 3<br>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). | Device: Extended Wear infusion set<br>* For two of the 4 weeks the Extended Wear insulin infusion set will be used.<br>Device: Standard Infusion set<br>* For two of the 4 weeks the Standard infusion set will be used<br>* Other names: Minimed;Drug: Heparin<br> <br> |
| Experimental: Protocol 2 (Part 1): Sequence 4<br>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). | Device: Extended Wear infusion set<br>* For two of the 4 weeks the Extended Wear insulin infusion set will be used.<br>Device: Standard Infusion set<br>* For two of the 4 weeks the Standard infusion set will be used<br>* Other names: Minimed;Drug: Heparin<br> <br> |
| Experimental: Protocol 2 (Part 1): Sequence 5<br>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). | Device: Extended Wear infusion set<br>* For two of the 4 weeks the Extended Wear insulin infusion set will be used.<br>Device: Standard Infusion set<br>* For two of the 4 weeks the Standard infusion set will be used<br>* Other names: Minimed;Drug: Heparin<br> <br> |
| Experimental: Protocol 2 (Part 2): Standard then Extended Set<br>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. | Device: Extended Wear infusion set<br>* For two of the 4 weeks the Extended Wear insulin infusion set will be used.<br>Device: Standard Infusion set<br>* For two of the 4 weeks the Standard infusion set will be used<br>* Other names: Minimed;Drug: Heparin<br> <br> |
| Experimental: Protocol 2 (Part 1): Extended then Standard Set<br>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. | Device: Extended Wear infusion set<br>* For two of the 4 weeks the Extended Wear insulin infusion set will be used.<br>Device: Standard Infusion set<br>* For two of the 4 weeks the Standard infusion set will be used<br>* Other names: Minimed;Drug: Heparin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| signs of infection at insulin infusion site | erythema or induration of > 1cm in diameter at injection site | 1 week |