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NCT04810780 Clinical Trial

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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04810780
Other study ID # Sheba-20-7386-at-ctil
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date December 1, 2021

Study information
Verified date May 2022
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date December 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Sheba Medical Center Tel-Hashomer

Sponsors (2)
Lead Sponsor Collaborator
Sheba Medical Center Medtronic

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primery Effectivness Endpoint Precent of catheters reaching 7- day without set failure. 28 days
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