The PSIQS Study - User Experience With Pro-Set

Not Applicable

Withdrawn

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: MiniMed® Pro-set®; Device: MiniMed® Quick-set®

• Registration Number: NCT03242005
• Lead Sponsor: Becton, Dickinson and Company

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®

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-04
• Study First Posted: 2017-08-08
• Status Verified: 2017-09
• Study Start: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-14
• Primary Completion: 2017-12
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pro-set® vs. Quick-set®	MiniMed® Pro-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.
Pro-set® vs. Quick-set®	MiniMed® 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 set removals due to hyperglycemia; > 400mg/dl.	6 hours from time of 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)