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OpenTrials
Completed

NCT Number: NCT04810780

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center

Tel Litwinsky, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DUO Extended Set

Device

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

Primary outcomes

  1. Primery Effectivness Endpoint

    Time frame: 28 days

    Precent of catheters reaching 7- day without set failure.

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • Medtronic

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2021
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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