NCT04810780

Brief Summary

The study will follow subjects for 28 days while using an DUO extended infusion set combined with glucose sensor. the objective is to evaluate saftey and efficacy of the set in adult patient with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

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

Study Start

First participant enrolled

March 1, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

March 21, 2021

Last Update Submit

May 12, 2022

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Primery Effectivness Endpoint

    Precent of catheters reaching 7- day without set failure.

    28 days

Study Arms (1)

1st arm

EXPERIMENTAL

Wearing the Duo infusion set for up to 1 month or up to 4 infusion set failures.

Device: DUO Extended Set

Interventions

DUO Extended SetDEVICE

to evaluate saftey and efficacy of DUO extended set combined with glucose sensor

1st arm

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™ 670G or 640G Insulin pump with Guardian 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
  • Subject has Glycosylated hemoglobin (HbA1c) \> 10 % at time of screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

  • amir Tirosh, MD PhD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Division of Endocrinology

Study Record Dates

First Submitted

March 21, 2021

First Posted

March 23, 2021

Study Start

March 1, 2021

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)