BD FlowSmart™ Subcutaneous Insulin Infusion Set User Preference and Claims Study

NCT ID: NCT02662842

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-02-29

Brief Summary

Continuous Subcutaneous Insulin Infusion (CSII) via insulin pump therapy has been shown to improve quality of life and glucose control in many patients with diabetes opting for this treatment modality. Despite significant innovation and advancement in pump technology, insulin infusion sets have been an area where innovation has been significantly lacking with no clinical studies performed prior to product launches.

BD has developed a subcutaneous infusion set with FlowSmart™ Technology designed to address patient comfort, insulin delivery and flow interruptions. According to preliminary animal and clinical studies, this technology results in lower infusion pressure indicating more consistent insulin delivery.

The FlowSmart infusion set has been previously tested in prototype form with healthy non-diabetic subjects with the sets inserted by nurses, and with CSII-using patients who self-inserted the FlowSmart infusion set in a clinical research setting.

The purpose of this study is to determine if insulin pump users prefer using the BD FlowSmart infusion set compared to their current set with respect to insertion pain and wear comfort.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

FlowSmart Infusion set, then current set

Subjects will use the FlowSmart Infusion Set for a period of 9 to 11 days, then switch to their current infusion set for another period of 9 to 11 days. Subjects must use at least 3 sets during each Study Period then - Subjects will use their current infusion set for a period of 9 to 11 days, then switch to the FlowSmart infusion set for another period of 9 to 11 days. Subjects must use at least 3 sets during each Study Period.

FlowSmart Infusion Set

Intervention Type: DEVICE

Use of set for subcutaneous insulin infusion, with set change every three days.

Current Infusion Set

Intervention Type: DEVICE

Use of set for subcutaneous insulin infusion, with set change every three days.

Interventions

FlowSmart Infusion Set

Use of set for subcutaneous insulin infusion, with set change every three days.

Intervention Type: DEVICE

Current Infusion Set

Use of set for subcutaneous insulin infusion, with set change every three days.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Must be 18-75 years of age, inclusive
• Have type 1 diabetes
• Treating diabetes with CSII for at least 12 months
• Currently using a soft catheter infusion set that is inserted 90° to body surface
• Have HbA1c ≤ 9.0% (tested at enrollment)
• Willing to do self monitoring of blood glucose (SMBG) using the supplied BG meter
• Able to read, write and follow instructions in English
• Able and willing to provide informed consent
• Willing to use each infusion set (both study and current) for 72 hours (3 days)
• Willing to use their usual insertion method (manual or mechanical inserter) with both infusion sets

Exclusion Criteria

• Pregnant (pre-menopausal females only; tested at enrollment)
• Recent history (within 6 months) of unstable diabetes including ketoacidosis, hyperglycemia and/or hypoglycemia requiring hospitalization(self-reported)
• Physical conditions that restrict dexterity and may limit ability to perform study procedure (e.g., severe neuropathy or arthritis of the hands, self-reported)
• Any other condition the PI or designee deems to pose a risk to the subject in the study
• Currently taking steroidal medications (self-reported)
• Acutely ill as determined by the Principal Investigator.
• Currently using an insulin infusion pump whose insulin reservoir is not compatible with either a Paradigm or Luer connector, such as Sooil Dana, Asante Snap, and Accu-Chek insight
• Currently using a disposable (patch) insulin pump, such as the Insulet Omnipod and the Valeritas V-Go
• Currently using a Teflon infusion set that is not inserted at a 90° angle, such as the Animas Comfort, Animas Inset 30, Medtronic Silhouette, or a steel infusion set, such as the Accu-Chek Rapid-D or Medtronic Sure-T
• Currently using Advanced Diabetes Research (ADR) reservoirs
• Currently participating in any other clinical investigations that conflicts with this one, or who have participated in a study with the same indication within the last 3 months and that the Principal Investigator or designee believes will conflict with outcomes or ability of the subject to complete all activities required in the study
• Participated in one or more of the following BD studies: DBC-14SCARL10 and DBC-14SCARL13
• Employed by, or currently serving as a contractor or consultant to BD or study site

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Becton, Dickinson and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurence Hirsch, MD

Role: STUDY_DIRECTOR

Becton Dickinson, World Wide VP Diabetes Care

Locations

AMCR Institute Inc.

Escondido, California, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, United States

TKL Research

Fair Lawn, New Jersey, United States

Countries

United States

Other Identifiers

DBC-15SCARL15

Identifier Type: -

Identifier Source: org_study_id