Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov 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Recruitment Status : Withdrawn (Sponsor decision to not proceed with study - no subjects enrolled)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
Sponsor:
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

Layout table for study information
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.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Layout table for additonal information
Responsible Party: Becton, Dickinson and Company
ClinicalTrials.gov 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

Layout table for additional information
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:
Layout table for MeSH terms
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases