The PSIQS Study - User Experience With Pro-Set

Study Overview
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Brief Summary
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Open label, randomized 2-period cross-over study comparing two continuous subcutaneous insulin infusion sets ; MiniMed® Pro-set® with BD FlowSmart™ technology and MiniMed® Quick-set®

Official Title
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The PSIQS Study - User Experience With the Pro-Set Over Intended Wear of 3 Days With New Instructions and Requirement to be Inserted With the Quick-Serter

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: MiniMed® Pro-set®
* Device: MiniMed® Quick-set®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be between 13 and 70 years of age (inclusive) Must have been previously diagnosed with type 1 diabetes mellitus Must be using one of the following Medtronic insulin pumps with the Paradigm connector (note 670G excluded) for at least 6 months prior to enrollment. These pumps must have the ability to upload data to Medtronic CareLink Therapy Management software. MiniMed Paradigm Revel™ Insulin Pump - models 523 (1.8 mL reservoir) and 723 (3 mL reservoir) MiniMed 530G Pump - models 551 (1.8 mL reservoir) and 751 (3 mL reservoir) MiniMed 630G System Must have been using the Medtronic Enlite CGM for at least 3 months prior to enrollment, and are currently doing so Must routinely insert their own infusion set (may be inserted manually or with an inserter or with an integrated set/inserter, i.e. Mio) If instructed, must be willing to insert all assigned infusion sets with a mechanical inserter Must have another form of insulin delivery available (i.e. vial and syringe or pen and pen needle) Must agree to continue using current Medtronic Enlite CGM throughout the study Willing to have insulin pump, BGM and CGM data downloaded into Medtronic CareLink Therapy Management Software (requires subject CareLink logon ID and password) In stable health status with no acute or significant illness, in the opinion of the investigator or designee Able to read, write and follow instructions in English Able and willing to provide informed consent Able and willing to comply with study procedures Exclusion Criteria: Pregnant (self-attestation) or nursing Currently using a body-worn patch insulin infusion pump, e.g. Omnipod or V-Go Currently using the Medtronic Model 670G pump and associated CGM Current or past participation in previous BD Study DBC-16SCARL21 History of bleeding disorder or easy bruising. Currently taking anti-platelet therapy or anticoagulants (use of up to 81 mg per day of aspirin is permitted). Known blood borne infections. History of recurrent dermatological condition or skin disorder (e.g. psoriasis, eczema, pre-existing dermatitis). Skin abnormalities, anomalies or conditions (e.g. sunburn, tattoos, extensive scarring, lipohypertrophy) located at or very close to the intended insertion site. Physical condition that restricts dexterity and may limit ability to perform study procedures (i.e. severe neuropathy or arthritis of the hands; self-reported) Currently participating in any other clinical investigation that conflicts with this study Employed by, or currently serving as a contractor or consultant to BD, Medtronic or study site Any other condition the investigator or designee deems to pose an unacceptable risk to the subject in the study

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 70 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pro-set® vs. Quick-set®<br>Subjects will be randomized to start with one of the study subcutaneous insulin administration sets (MiniMed® Pro-set® or MiniMed® Quick-set®). After completing the first study period,subjects will be placed in the alternative group according to the cross-over study design. | Device: MiniMed® Pro-set®<br>* Utilization of the MiniMed® Pro-set® to administer the subject's current insulin therapy.<br>Device: MiniMed® Quick-set®<br>* Utilization of the MiniMed® Quick-set® to administer the subject's current insulin therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Pro-set® vs. Quick-set® for non-inferiority for set insertion failures (set removal) due to either occlusion alerts or hyperglycemia |  | 6 hours from time of insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Pro-set® vs. Quick-set® for set removals due to hyperglycemia; > 400mg/dl. |  | 6 hours from time of insertion | 
| Compare Pro-set® vs. Quick- set® for set removals due to set failure; hyperglycemia >250mg/dl. |  | 72 hours of set wear that occurs at 6 hours or later after insertion | 
| Compare Pro-set® vs. Quick- set® for set removals at less than 60 hours post insertion. |  | 60 hours post insertion | 
| Compare Pro-set® vs. Quick- set® for duration of wear |  | % reaching 12 hours, % reaching 24 hours, % reaching 36 hours, % reaching 48 hours, % reaching 60 hours, and % reaching 72 hours) |