Longevity of Multi-Slitted Catheter With Lantern Technology (Lantern)
Primary Purpose
Insulin Dependent Diabetes Mellitus 1
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inset II with Lantern Technology
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Dependent Diabetes Mellitus 1
Eligibility Criteria
Inclusion Criteria:
Type 1 Diabetes by clinical definition
- Age 22 and over
- On tethered insulin pump therapy for at least 3 months using Lispro or Aspart insulin.
- Hemoglobin A1c level less than or equal to 9%
- Eating more than 60 grams of carbohydrate each day
- For females, not currently known to be pregnant
- Understanding and willingness to follow the protocol and sign informed consent
- Willingness to wear the experimental infusion sets
- Willingness to have photographs taken of their infusion sites
- 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:
- Diabetic ketoacidosis in the past 3 months
- Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
- Pregnant or lactating
- Known tape allergies
- Active infection
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
- Known cardiovascular events in the last 6 months
- Known acute proliferative diabetic retinopathy
- Known adrenal disorder
- Current treatment for a seizure disorder
- Inpatient psychiatric treatment in the past 6 months
- Lack of stability on medication 1 month prior to enrollment including antihypertensive, thyroid, anti-depressant or lipid lowering medication.
- Use of SGLT inhibitor
- Suspected drug or alcohol abuse
- Dialysis or end stage kidney disease
Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
Sites / Locations
- Stanford
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lantern infusion set
Arm Description
Multi-slitted lantern infusion set
Outcomes
Primary Outcome Measures
Time to Infusion Set Failure
Time to when the infusion set fails and needs to be replaced.
Secondary Outcome Measures
Full Information
NCT ID
NCT03819634
First Posted
January 24, 2019
Last Updated
May 3, 2021
Sponsor
Stanford University
Collaborators
ConvaTec Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03819634
Brief Title
Longevity of Multi-Slitted Catheter With Lantern Technology
Acronym
Lantern
Official Title
Longevity of Multi-Slitted Catheter, the Convatec Inset II With Lantern Technology
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
April 20, 2019 (Actual)
Study Completion Date
April 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
ConvaTec Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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:
Presence of serum ketones with hyperglycemia
Unexplained hyperglycemia
Signs of infection at the infusion site
Pump occlusion alarm
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Dependent Diabetes Mellitus 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
To determine length of infusion set wear for up to a maximum of 10 days
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lantern infusion set
Arm Type
Experimental
Arm Description
Multi-slitted lantern infusion set
Intervention Type
Device
Intervention Name(s)
Inset II with Lantern Technology
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Infusion Set Failure
Description
Time to when the infusion set fails and needs to be replaced.
Time Frame
10 days of infusion set wear
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 Diabetes by clinical definition
Age 22 and over
On tethered insulin pump therapy for at least 3 months using Lispro or Aspart insulin.
Hemoglobin A1c level less than or equal to 9%
Eating more than 60 grams of carbohydrate each day
For females, not currently known to be pregnant
Understanding and willingness to follow the protocol and sign informed consent
Willingness to wear the experimental infusion sets
Willingness to have photographs taken of their infusion sites
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:
Diabetic ketoacidosis in the past 3 months
Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
Pregnant or lactating
Known tape allergies
Active infection
A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
Known cardiovascular events in the last 6 months
Known acute proliferative diabetic retinopathy
Known adrenal disorder
Current treatment for a seizure disorder
Inpatient psychiatric treatment in the past 6 months
Lack of stability on medication 1 month prior to enrollment including antihypertensive, thyroid, anti-depressant or lipid lowering medication.
Use of SGLT inhibitor
Suspected drug or alcohol abuse
Dialysis or end stage kidney disease
Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce A Buckingham, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33822472
Citation
Lal RA, Hsu L, Zhang J, Schondorff PK, Heschel M, Buckingham B. Longevity of the novel ConvaTec infusion set with Lantern technology. Diabetes Obes Metab. 2021 Aug;23(8):1973-1977. doi: 10.1111/dom.14395. Epub 2021 Apr 18.
Results Reference
result
Learn more about this trial
Longevity of Multi-Slitted Catheter With Lantern Technology
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