The PSIQS Study - User Experience With Pro-Set

NCT03242005 | Withdrawn FDA Device

• 1 other identifier: DBC-17SCARL23
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

Study Arms (1)

Pro-set® vs. Quick-set®

EXPERIMENTAL

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®; Device: MiniMed® Quick-set®

Interventions

MiniMed® Pro-set® DEVICE

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

Pro-set® vs. Quick-set®

MiniMed® Quick-set® DEVICE

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

Pro-set® vs. Quick-set®

Eligibility Criteria

• Age: 13 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 8, 2017
• Study Start: September 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: September 14, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share