Safety and Efficacy of DUO Extended Set: Combined Glucose... | NCT04810780

Studies
Safety and Efficacy of DUO Extended Set: Combined Glucose Sensor and Infusion Set.

NCT04810780

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

May 17, 2022Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Type 1 Diabetes

Interventions

DUO Extended Set

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Jun 1, 2021Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Mar 21, 2021

First Submission Date that Met QC Criteria

Mar 21, 2021

First Posted Date

Mar 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2022

Last Update Posted Date

May 17, 2022Actual

Name	Class
Medtronic	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
DUO Extended Set	Device	to evaluate saftey and efficacy of DUO extended set combined with glucose sensor	1st arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primery Effectivness Endpoint	Precent of catheters reaching 7- day without set failure.	28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
amir Tirosh, MD PhD	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Tel Litwinsky			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided