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Trial record 70 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

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

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: NCT02662842
Recruitment Status : Completed
First Posted : January 26, 2016
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Becton, Dickinson and Company

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.


Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Device: FlowSmart Infusion Set Device: Current Infusion Set

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: BD FlowSmart™ User Claims Study
Study Start Date : January 2016
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Group/Cohort Intervention/treatment
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.
Device: FlowSmart Infusion Set
Use of set for subcutaneous insulin infusion, with set change every three days.

Device: Current Infusion Set
Use of set for subcutaneous insulin infusion, with set change every three days.




Primary Outcome Measures :
  1. Comparative Infusion Set Insertion Pain [ Time Frame: Comparative pain measure assessed at the end of Study Period 2, after 9-11 days use of each infusion set type ]
    At the study visit after completing both study periods (Visit 3), subjects will use a 15 cm Visual Analog Scale (VAS) to indicate which insertion set was less painful to insert, the BD Flowsmart or their current infusion set. Effects of infusion set type will be tested for statistical significance using linear mixed models adjusting for the effect of subject, study site and period. The model will be used to generate a two-sided 95% confidence interval for the adjusted average pain rating using a multiple comparison approach.

  2. Comparative Infusion Set Wear Comfort [ Time Frame: Comparative pain measure assessed at the end of Study Period 2, after 9-11 days use of each infusion set type ]
    At the study visit after completing both study periods (Visit 3), subjects will use a 15 cm Visual Analog Scale (VAS) to indicate which set was more comfortable to wear, the BD FlowSmart or their current infusion set. Only if reduced Pain (outcome 1) for FlowSmart if achieved will wear comfort be further analyzed. Effects of infusion set type will be tested for statistical significance using linear mixed models adjusting for the effect of subject, study site and period. The model will be used to generate a two-sided 95% confidence interval for the adjusted average comfort rating using a multiple comparison approach.


Secondary Outcome Measures :
  1. Overall Infusion Set Preference [ Time Frame: Assessed at the end of Study Period 2, after 9-11 days use of each infusion set type ]
    At the study visit after completing both study periods (Visit 3), subjects will use a 15 cm Visual Analog Scale (VAS) to indicate their preference for the BD Flowsmart compared to their current infusion set based on their recent experience. Effects of infusion set type will be tested for statistical significance using linear mixed models adjusting for the effect of subject, study site and period. The model will be used to generate a two-sided 95% confidence interval for the adjusted preference rating using a multiple comparison approach.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Study Population
Approximately 75 subjects with type 1 diabetes currently on CSII will participate in the study
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662842


Locations
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United States, California
AMCR Institute Inc.
Escondido, California, United States, 92025
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
United States, New Jersey
TKL Research
Fair Lawn, New Jersey, United States, 07410
Sponsors and Collaborators
Becton, Dickinson and Company
Medtronic
Investigators
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Study Director: Laurence Hirsch, MD Becton Dickinson, World Wide VP Diabetes Care

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Responsible Party: Becton, Dickinson and Company
ClinicalTrials.gov Identifier: NCT02662842     History of Changes
Other Study ID Numbers: DBC-15SCARL15
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Becton, Dickinson and Company:
infusion set
continuous subcutaneous insulin infusion

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs