The PSIQS Study - User Experience With Pro-Set

September 12, 2017 updated by: Becton, Dickinson and Company

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

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®

Study Overview

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 hours from time of insertion

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare Pro-set® vs. Quick-set® for set removals due to hyperglycemia; > 400mg/dl.
Time Frame: 6 hours from time of insertion
6 hours from time of insertion
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
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.
Time Frame: 60 hours post insertion
60 hours post insertion
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)
% reaching 12 hours, % reaching 24 hours, % reaching 36 hours, % reaching 48 hours, % reaching 60 hours, and % reaching 72 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

August 4, 2017

First Submitted That Met QC Criteria

August 4, 2017

First Posted (Actual)

August 8, 2017

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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