Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery

Charles University, Czech Republic

Status: Enrolling

Conditions: Diabetes Mellitus Type 1

Treatments: Device: Device: Insulin pump TouchCare Nano A8 with the APGO system

Study type: Interventional

Funder types: Other

Identifiers

NCT07320495

RENEW

Details and patient eligibility

About

The Medtrum TouchCare Nano system with the APGO algorithm is the only patch pump-based automated insulin delivery system available in the Czech Republic. However, until now, no prospective clinical study has evaluated its efficacy and safety under real-world conditions. The RENEW study is the first to address this topic.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with T1D
• type 1 diabetes for ≥1 years
• ≥ 18 years old
• written informed consent prior to starting study related activity

Exclusion criteria

• severe noncompliance
• lactation, pregnancy, intending to become pregnant during study
• use of medication with effects on carbohydrate metabolism

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Patients with TouchCare Nano A8 insulin pump with the APGO system

Experimental group

Description:

Patients with type 1 diabetes, who initiated use of the TouchCare Nano A8 insulin pump with the APGO system.

Treatment:

Device: Device: Insulin pump TouchCare Nano A8 with the APGO system