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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04810780

Enrollment

Registered

2021-03-23

Start date

2021-03-01

Completion date

2021-12-01

Last updated

2022-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

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.

Interventions

DEVICEDUO Extended Set

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026