NCT07320495

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Jun 2025Jun 2028

Study Start

First participant enrolled

June 19, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2028

Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

December 3, 2025

Last Update Submit

December 25, 2025

Conditions

Diabetes Mellitus Type 1

Keywords

automated insulin delivery systempatch pump

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Changes in percentage of time in hypoglycemic ranges <3.9 mmol/L (70 mg/dl) and <3.0 mmol/L (54 mg/dl)

    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)

    Up to 24 months

  • Changes in percentage of time in tight target ranges 3,9-7,8 mmol/L (70-140 mg/dl)

    Up to 24 months

  • Changes in average glycemia (mmol/L)

    Up to 24 months

  • Changes in estimated glycated haemoglobin GMI (%)

    Up to 24 months

  • +2 more secondary outcomes

Study Arms (1)

Patients with TouchCare Nano A8 insulin pump with the APGO system

EXPERIMENTAL

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

Interventions

Device: Insulin pump TouchCare Nano A8 with the APGO systemDEVICE

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.

Patients with TouchCare Nano A8 insulin pump with the APGO system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Prague, Czechia

RECRUITING

Related Publications (3)

  • 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.

    PMID: 39065641RESULT

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

    PMID: 30070604RESULT

  • 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.

    PMID: 35367523RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Jan Soupal

CONTACT

+420775654343jan.soupal@seznam.cz

Dat Do

CONTACT

+420608220784datdoquoc@seznam.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2025

First Posted

January 6, 2026

Study Start

June 19, 2025

Primary Completion (Estimated)

June 19, 2027

Study Completion (Estimated)

June 19, 2028

Last Updated

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)