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

Sheba Medical Center10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

DUO Extended SetDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sheba Medical Center

Tel Litwinsky, Israel

Outcomes

Primary Outcomes

Primery Effectivness Endpoint

Precent of catheters reaching 7- day without set failure.

Time frame: 28 days

Data from ClinicalTrials.gov

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