Longevity of Multi-Slitted Catheter With Lantern Technology

NCT ID: NCT03819634

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-25
• Study Completion Date: 2019-04-20

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.

Conditions

Insulin Dependent Diabetes Mellitus 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lantern infusion set

Multi-slitted lantern infusion set

Group Type: EXPERIMENTAL

Inset II with Lantern Technology

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ConvaTec Inc.

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Bruce Buckingham

Professor of Pediatric Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce A Buckingham, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford

Palo Alto, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 33822472 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB #45812

Identifier Type: -

Identifier Source: org_study_id