NCT03819634

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

January 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2019

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 25, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

January 24, 2019

Results QC Date

May 3, 2021

Last Update Submit

May 3, 2021

Conditions

Insulin Dependent Diabetes Mellitus 1

Outcome Measures

Primary Outcomes (1)

  • Time to Infusion Set Failure

    Time to when the infusion set fails and needs to be replaced.

    10 days of infusion set wear

Study Arms (1)

Lantern infusion set

EXPERIMENTAL

Multi-slitted lantern infusion set

Device: Inset II with Lantern Technology

Interventions

Inset II with Lantern TechnologyDEVICE

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.

Lantern infusion set

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford

Palo Alto, California, 94305, United States

Location

Related Publications (1)

  • 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.

    PMID: 33822472RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Bruce Buckingham
Organization
Stanford
buckingham@stanford.edu
6508040476

Study Officials

  • Bruce A Buckingham, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: To determine length of infusion set wear for up to a maximum of 10 days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatric Endocrinology

Study Record Dates

First Submitted

January 24, 2019

First Posted

January 28, 2019

Study Start

January 25, 2019

Primary Completion

April 20, 2019

Study Completion

April 20, 2019

Last Updated

May 25, 2021

Results First Posted

May 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)