Clinical trial NCT02662842: BD FlowSmart™ Subcutaneous Insulin Infusion Set User Preference and Claims Study
Official title: BD FlowSmart™ User Claims Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: infusion set
continuous subcutaneous insulin infusion
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2016-01-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Study population: Approximately 75 subjects with type 1 diabetes currently on CSII will participate in the study

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.


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

Primary outcomes:
measure: Comparative Infusion Set Insertion Pain
timeFrame: Comparative pain measure assessed at the end of Study Period 2, after 9-11 days use of each infusion set type
measure: Comparative Infusion Set Wear Comfort
timeFrame: Comparative pain measure assessed at the end of Study Period 2, after 9-11 days use of each infusion set type
Secondary outcomes:
measure: Overall Infusion Set Preference
timeFrame: Assessed at the end of Study Period 2, after 9-11 days use of each infusion set type
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute Inc.
state: California
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
city: Fair Lawn
country: United States
facility: TKL Research
state: New Jersey
Study officials:
affiliation: Becton Dickinson, World Wide VP Diabetes Care
name: Laurence Hirsch, MD
role: STUDY_DIRECTOR
References: