Clinical trial NCT03242005: The PSIQS Study - User Experience With Pro-Set
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2017-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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 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.

  1. MiniMed Paradigm Revel™ Insulin Pump - models 523 (1.8 mL reservoir) and 723 (3 mL reservoir)
  2. MiniMed 530G Pump - models 551 (1.8 mL reservoir) and 751 (3 mL reservoir)
  3. 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

Primary outcomes:
measure: Compare Pro-set® vs. Quick-set® for non-inferiority for set insertion failures (set removal) due to either occlusion alerts or hyperglycemia
timeFrame: 6 hours from time of insertion
Secondary outcomes:
measure: Compare Pro-set® vs. Quick-set® for set removals due to hyperglycemia; > 400mg/dl.
timeFrame: 6 hours from time of insertion
measure: Compare Pro-set® vs. Quick- set® for set removals due to set failure; hyperglycemia >250mg/dl.
timeFrame: 72 hours of set wear that occurs at 6 hours or later after insertion
measure: Compare Pro-set® vs. Quick- set® for set removals at less than 60 hours post insertion.
timeFrame: 60 hours post insertion
measure: Compare Pro-set® vs. Quick- set® for duration of wear
timeFrame: % reaching 12 hours, % reaching 24 hours, % reaching 36 hours, % reaching 48 hours, % reaching 60 hours, and % reaching 72 hours)
Other outcomes:
Locations:
Study officials:
References: