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Longevity of Multi-Slitted Catheter With Lantern Technology (Lantern)

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: NCT03819634
Recruitment Status : Completed
First Posted : January 28, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
ConvaTec Inc.
Information provided by (Responsible Party):
Bruce A. Buckingham, Stanford University

Tracking Information
First Submitted Date  ICMJE January 24, 2019
First Posted Date  ICMJE January 28, 2019
Last Update Posted Date September 20, 2019
Actual Study Start Date  ICMJE January 25, 2019
Actual Primary Completion Date April 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
Time to infusion set failure [ Time Frame: 10 days of infusion set wear ]
Time to when the infusion set fails and needs to be replaced for:
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Longevity of Multi-Slitted Catheter With Lantern Technology
Official Title  ICMJE Longevity of Multi-Slitted Catheter, the Convatec Inset II With Lantern Technology
Brief Summary To determine time to set failure when the Convatec Inset II with Lantern technology (Convatec Lantern) infusion set with multi-slitted catheter is worn for up to 10 days
Detailed Description

This is a pilot study to obtain preliminary data to determine the time to set failure when the Lantern infusion set is worn for up to 10 days. The study is not intended for registration purposes or to support a 510(k) submission. The study will be conducted at one site: Stanford University.

This study will enroll 24 subjects (as per FDA approval) to establish the maximum length of Lantern infusion set wear when 80% of sets are still functional (excluding accidental "pull-outs"). Each participant will place the set and wear it for 10 days or until set failure and data will be collected on the cause of set failure. If a set is accidentally pulled out, it can be replaced by the subject. Failures are based on:

  1. Presence of serum ketones with hyperglycemia
  2. Unexplained hyperglycemia
  3. Signs of infection at the infusion site
  4. Pump occlusion alarm
  5. Adhesive failure

Since infusion set failures will occur after variable lengths of wear, regularly scheduled visits are unlikely to capture the day of an infusion set failure. Instead the subject will be taught how to insert the set, measure erythema and induration with a ruler marked in millimeters and to take a picture of the infusion site. Subjects will be instructed to text the study team when they remove their infusion set and to send a picture of the infusion site and measurements. If there is any evidence of an infection (≥10 mm of erythema or induration), they will be asked to come in that day for an unscheduled visit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
To determine length of infusion set wear for up to a maximum of 10 days
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Insulin Dependent Diabetes Mellitus 1
Intervention  ICMJE Device: Inset II with Lantern Technology
Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.
Study Arms  ICMJE Experimental: Lantern infusion set
Multi-slitted lantern infusion set
Intervention: Device: Inset II with Lantern Technology
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 20, 2019
Actual Primary Completion Date April 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Type 1 Diabetes by clinical definition

  1. Age 22 and over
  2. On tethered insulin pump therapy for at least 3 months using Lispro or Aspart insulin.
  3. Hemoglobin A1c level less than or equal to 9%
  4. Eating more than 60 grams of carbohydrate each day
  5. For females, not currently known to be pregnant
  6. Understanding and willingness to follow the protocol and sign informed consent
  7. Willingness to wear the experimental infusion sets
  8. Willingness to have photographs taken of their infusion sites
  9. Ability to speak, read and write in the language of the investigators

Exclusion Criteria:

The presence of any of the following is an exclusion for the study:

  1. Diabetic ketoacidosis in the past 3 months
  2. Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
  3. Pregnant or lactating
  4. Known tape allergies
  5. Active infection
  6. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
  7. Known cardiovascular events in the last 6 months
  8. Known acute proliferative diabetic retinopathy
  9. Known adrenal disorder
  10. Current treatment for a seizure disorder
  11. Inpatient psychiatric treatment in the past 6 months
  12. Lack of stability on medication 1 month prior to enrollment including antihypertensive, thyroid, anti-depressant or lipid lowering medication.
  13. Use of SGLT inhibitor
  14. Suspected drug or alcohol abuse
  15. Dialysis or end stage kidney disease

Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03819634
Other Study ID Numbers  ICMJE IRB #45812
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bruce A. Buckingham, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE ConvaTec Inc.
Investigators  ICMJE
Principal Investigator: Bruce A Buckingham, MD Stanford University
PRS Account Stanford University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP