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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04810780
Recruitment Status : Not yet recruiting
First Posted : March 23, 2021
Last Update Posted : March 23, 2021
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Prof. Amir Tirosh, Sheba Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: DUO Extended Set Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of DUO Extended Set: Combined Glucose Sensor and Infusion Set.
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Device: DUO Extended Set
    to evaluate saftey and efficacy of DUO extended set combined with glucose sensor

Outcome Measures
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Primary Outcome Measures :
  1. to asses the wear duration of duo set for effective insulin delivery. [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04810780


Contacts
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Contact: Amir Tirosh, MD PhD +972526666777 amir.tirosh@sheba.health.gov.il
Contact: maya laron hirsh, B.Sc +972544706640 maya.laron-hirsh@sheba.gov.il

Locations
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Israel
Sheba Medical Center
Tel-Hashomer, Israel
Sponsors and Collaborators
Sheba Medical Center
Medtronic
Investigators
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Principal Investigator: amir Tirosh, MD PhD Sheba Medical Center
More Information
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Responsible Party: Prof. Amir Tirosh, Director, Division of Endocrinology, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT04810780    
Other Study ID Numbers: Sheba-20-7386-at-ctil
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases