Clinical trial NCT03819634: Longevity of Multi-Slitted Catheter With Lantern Technology
Official title: Longevity of Multi-Slitted Catheter, the Convatec Inset II With Lantern Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Dependent Diabetes Mellitus 1
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: ConvaTec Inc.
First posted: 2019-01-28
Enrollment: 24
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To determine length of infusion set wear for up to a maximum of 10 days
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time to Infusion Set Failure
timeFrame: 10 days of infusion set wear
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford
state: California
Study officials:
affiliation: Stanford University
name: Bruce A Buckingham, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.