Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery

NCT ID: NCT07320495

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-19

Study Completion Date

2028-06-19

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Type 1

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with TouchCare Nano A8 insulin pump with the APGO system

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

Group Type EXPERIMENTAL

Device: Insulin pump TouchCare Nano A8 with the APGO system

Intervention Type DEVICE

Insulin pump Medtrum TouchCare Nano A8 with the APGO algorithm is the only patch pump-based automated insulin delivery system available in the Czech Republic.

Interventions

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Device: Insulin pump TouchCare Nano A8 with the APGO system

Insulin pump Medtrum TouchCare Nano A8 with the APGO algorithm is the only patch pump-based automated insulin delivery system available in the Czech Republic.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czechia

Prague, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Jan Soupal

Role: CONTACT

+420775654343

Dat Do

Role: CONTACT

+420608220784

Facility Contacts

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Jan Soupal

Role: primary

+420775654343

References

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Rimon MTI, Hasan MW, Hassan MF, Cesmeci S. Advancements in Insulin Pumps: A Comprehensive Exploration of Insulin Pump Systems, Technologies, and Future Directions. Pharmaceutics. 2024 Jul 15;16(7):944. doi: 10.3390/pharmaceutics16070944.

Reference Type RESULT
PMID: 39065641 (View on PubMed)

Ginsberg BH. Patch Pumps for Insulin. J Diabetes Sci Technol. 2019 Jan;13(1):27-33. doi: 10.1177/1932296818786513. Epub 2018 Aug 2.

Reference Type RESULT
PMID: 30070604 (View on PubMed)

Kulzer B, Freckmann G, Heinemann L, Schnell O, Hinzmann R, Ziegler R. Patch Pumps: What are the advantages for people with diabetes? Diabetes Res Clin Pract. 2022 May;187:109858. doi: 10.1016/j.diabres.2022.109858. Epub 2022 Apr 1.

Reference Type RESULT
PMID: 35367523 (View on PubMed)

Other Identifiers

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RENEW

Identifier Type: -

Identifier Source: org_study_id

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