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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
DUO Extended Set
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Clinical diagnosis of type 1 diabetes for at least one year
  2. Using a MiniMed™ 670G or 640G Insulin pump with Guardian sensor
  3. Age 18 to 80 years
  4. Hemoglobin A1c level less than or equal to 10%
  5. Not currently known to be pregnant, nor planning pregnancy during the study.
  6. Willingness to follow the protocol and sign the informed consent

Exclusion Criteria:

  1. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
  2. Pregnant or lactating females
  3. Subject has Glycosylated hemoglobin (HbA1c) > 10 % at time of screening.

Sites / Locations

  • Sheba Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1st arm

Arm Description

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

Outcomes

Primary Outcome Measures

Primery Effectivness Endpoint
Precent of catheters reaching 7- day without set failure.

Secondary Outcome Measures

Full Information

First Posted
March 21, 2021
Last Updated
May 12, 2022
Sponsor
Sheba Medical Center
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT04810780
Brief Title
Safety and Efficacy of DUO Extended Set: Combined Glucose Sensor and Infusion Set.
Official Title
Safety and Efficacy of DUO Extended Set: Combined Glucose Sensor and Infusion Set.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
Collaborators
Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1st arm
Arm Type
Experimental
Arm Description
Wearing the Duo infusion set for up to 1 month or up to 4 infusion set failures.
Intervention Type
Device
Intervention Name(s)
DUO Extended Set
Intervention Description
to evaluate saftey and efficacy of DUO extended set combined with glucose sensor
Primary Outcome Measure Information:
Title
Primery Effectivness Endpoint
Description
Precent of catheters reaching 7- day without set failure.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
amir Tirosh, MD PhD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Tel-Hashomer
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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