Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery

Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery: The RENEW 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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus Type 1
• Intervention / Treatment: Device: Device: Insulin pump TouchCare Nano A8 with the APGO system

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Soupal; Phone Number: +420775654343; Email: jan.soupal@seznam.cz
• Study Contact Backup: Name: Dat Do; Phone Number: +420608220784; Email: datdoquoc@seznam.cz

Study Locations

• Czechia
  • Prague, Czechia
    • Recruiting
    • 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czechia
    • Contact: Jan Soupal; Phone Number: +420775654343; Email: jan.soupal@seznam.cz
    • Principal Investigator: Jan Soupal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in glycated haemoglobin (HbA1c)	Differences between HbA1c values in the Visit 0 and Visit 24	Up to 24 months
Changes in percentage of time in target ranges 3,9-10,0 mmol/L (70-180 mg/dl)	Differences between percentage of time in target ranges in the Visit 0 and Visit 24	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in percentage of time in hypoglycemic ranges <3.9 mmol/L (70 mg/dl) and <3.0 mmol/L (54 mg/dl)	Differences between percentage of time in hypoglycemic ranges in the Visit 0 and Visit 24	Up to 24 months
Changes in percentage of time in hyperglycemic ranges >10,0 mmol/L (180 mg/dl) and >13,9 mmol/L (250 mg/dl)	Differences between percentage of time in hyperglycemic ranges in the Visit 0 and Visit 24	Up to 24 months
Changes in percentage of time in tight target ranges 3,9-7,8 mmol/L (70-140 mg/dl)	Differences between percentage of time in tight target ranges in the Visit 0 and Visit 24	Up to 24 months
Changes in average glycemia (mmol/L)	Differences between average glycemia in the Visit 0 and Visit 24	Up to 24 months
Changes in estimated glycated haemoglobin GMI (%)	Differences between estimated glycated haemoglobin GMI in the Visit 0 and Visit 24	Up to 24 months
Changes in glycemic variability expressed as the coefficient of variation (%)	Differences between glycemic variability in the Visit 0 and Visit 24	Up to 24 months
Time spent in automated insulin delivery mode	Expressed as percentage of time	Up to 24 months

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2025
• Primary Completion (Estimated): June 19, 2027
• Study Completion (Estimated): June 19, 2028

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 25, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 25, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: automated insulin delivery system; patch pump
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: RENEW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No