The PSIQS Study - User Experience With Pro-Set

NCT ID: NCT03242005

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2018-02-28

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®

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pro-set® vs. Quick-set®

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.

Group Type: EXPERIMENTAL

MiniMed® Pro-set®

Intervention Type: DEVICE

Utilization of the MiniMed® Pro-set® to administer the subject's current insulin therapy.

MiniMed® Quick-set®

Intervention Type: DEVICE

Utilization of the MiniMed® Quick-set® to administer the subject's current insulin therapy.

Interventions

MiniMed® Pro-set®

Utilization of the MiniMed® Pro-set® to administer the subject's current insulin therapy.

Intervention Type: DEVICE

MiniMed® Quick-set®

Utilization of the MiniMed® Quick-set® to administer the subject's current insulin therapy.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Becton, Dickinson and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

DBC-17SCARL23

Identifier Type: -

Identifier Source: org_study_id