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Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery
NCT07320495 · Charles University, Czech Republic
In plain English
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Official title
Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery: The RENEW Study
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 200 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-06-19
Estimated completion: 2028-06-19
Last updated: 2026-01-06
Interventions
Device: Device: Insulin pump TouchCare Nano A8 with the APGO system
Primary outcomes
- • Changes in glycated haemoglobin (HbA1c) (Up to 24 months)
- • Changes in percentage of time in target ranges 3,9-10,0 mmol/L (70-180 mg/dl) (Up to 24 months)
Sponsor
Charles University, Czech Republic · other
Contacts & investigators
ContactJan Soupal · contact · jan.soupal@seznam.cz · +420775654343
ContactDat Do · contact · datdoquoc@seznam.cz · +420608220784
All locations (1)
3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, CzechiaRecruiting
Prague, Czechia