NCT04208282

Brief Summary

The purpose of this study is to evaluate the Extended Wear (EW) infusion set seven day functioning in patients with Type 1 diabetes compared to the Quick-set infusion set. The study will be carried out in adults with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration 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

Study Start

First participant enrolled

July 1, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

2.7 years

First QC Date

December 19, 2019

Last Update Submit

May 3, 2020

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

  • Primary

    • Percent of catheters reaching 4, 5, 6, 7 days use without set failure.

    8 weeks

Secondary Outcomes (1)

  • Exploratory outcomes

    8 weeks

Other Outcomes (1)

  • Adverse Events

    8 weeks

Study Arms (2)

Trial Arm A

EXPERIMENTAL

Quickset infusion system for the Phase 1. At day 28 or after using 4 sets , the patients will return to a visit, return all the extracted catheters sets and will switch to the 7 day set infusion set, entering Phase 2.

Device: 7 day infusion set

Trial Arm B

ACTIVE COMPARATOR

7 day set infusion set for the Phase 1. At day 28 or after using 4 sets , the patients will return to a visit, return all the extracted catheters sets and will switch to the Quickset infusion systems , entering Phase 2.

Device: 7 day infusion set

Interventions

7 day infusion setDEVICE

7 days survival of the sets

Trial Arm ATrial Arm B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of type 1 diabetes for at least one year
  • Using a MiniMed™ VEO pump or 640G Insulin pump with or without using an Enlite™ Sensor .
  • Age 18 to 80 years
  • Hemoglobin A1c level less than or equal to 10%
  • Not currently known to be pregnant, nor planning pregnancy during the study.
  • Willingness to follow the protocol and sign the informed consent

You may not qualify if:

  • A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
  • Pregnant or lactating females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 19, 2019

First Posted

December 23, 2019

Study Start

July 1, 2017

Primary Completion

March 30, 2020

Study Completion

March 31, 2020

Last Updated

May 5, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)