The PSIQS Study - User Experience With Pro-Set

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03242005
• Other study ID #: DBC-17SCARL23
• Status: Withdrawn
• Phase: N/A
• First received: August 4, 2017
• Last updated: September 12, 2017
• Start date: September 2017
• Est. completion date: February 2018

Study information

• Verified date: September 2017
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare Pro-set® vs. Quick-set® for set removals due to hyperglycemia; > 400mg/dl.		6 hours from time of insertion
Secondary	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
Secondary	Compare Pro-set® vs. Quick- set® for set removals at less than 60 hours post insertion.		60 hours post insertion
Secondary	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)