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The PSIQS Study - User Experience With Pro-Set

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03242005
Recruitment Status : Withdrawn (Sponsor decision to not proceed with study - no subjects enrolled)
First Posted : August 8, 2017
Last Update Posted : September 14, 2017
Information provided by (Responsible Party):
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®

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: MiniMed® Pro-set® Device: MiniMed® Quick-set® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Device: MiniMed® Pro-set®
Utilization of the MiniMed® Pro-set® to administer the subject's current insulin therapy.

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

Primary Outcome Measures :
  1. Compare Pro-set® vs. Quick-set® for non-inferiority for set insertion failures (set removal) due to either occlusion alerts or hyperglycemia [ Time Frame: 6 hours from time of insertion ]

Secondary Outcome Measures :
  1. Compare Pro-set® vs. Quick-set® for set removals due to hyperglycemia; > 400mg/dl. [ Time Frame: 6 hours from time of insertion ]
  2. Compare Pro-set® vs. Quick- set® for set removals due to set failure; hyperglycemia >250mg/dl. [ Time Frame: 72 hours of set wear that occurs at 6 hours or later after insertion ]
  3. Compare Pro-set® vs. Quick- set® for set removals at less than 60 hours post insertion. [ Time Frame: 60 hours post insertion ]
  4. Compare Pro-set® vs. Quick- set® for duration of wear [ Time Frame: % reaching 12 hours, % reaching 24 hours, % reaching 36 hours, % reaching 48 hours, % reaching 60 hours, and % reaching 72 hours) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Becton, Dickinson and Company Identifier: NCT03242005    
Other Study ID Numbers: DBC-17SCARL23
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases