Status:
WITHDRAWN
The PSIQS Study - User Experience With Pro-Set
Lead Sponsor:
Becton, Dickinson and Company
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
13-70 years
Phase:
NA
Brief Summary
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®
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03242005
Start Date
September 1 2017
End Date
February 1 2018
Last Update
September 14 2017
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