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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

About this trial

This is an interventional treatment trial for Insulin Dependent Diabetes Mellitus 1

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

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

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

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

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Longevity of Multi-Slitted Catheter With Lantern Technology

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