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

Sheba Medical Center

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: DUO Extended Set

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04810780

Sheba-20-7386-at-ctil

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

1st arm

Experimental group

Description:

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

Treatment:

Device: DUO Extended Set