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Diabetes Mellitus Type 1NCT07320495

Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery

A study testing Device: Insulin pump TouchCare Nano A8 with the APGO system in people with Diabetes Mellitus Type 1, run by Charles University, Czech Republic at 1 site in Czechia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus Type 1
What is being tested?
Device: Insulin pump TouchCare Nano A8 with the APGO system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteCzechia
Study dates
19 Jun 2025to 19 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jan Soupal contact

+420775654343

jan.soupal@seznam.cz

Dat Do contact

+420608220784

datdoquoc@seznam.cz

Czechia1 site, 1 recruiting

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

    Prague

    Jan Soupal, +420775654343, jan.soupal@seznam.cz

    Jan Soupal

    Recruiting

Other trials in Czechia

About this study

Official title: 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.

Being tested
Device: Insulin pump TouchCare Nano A8 with the APGO system
Keywords
automated insulin delivery system, patch pump
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07320495
Study groupRoleWhat they receive
Patients with TouchCare Nano A8 insulin pump with the APGO systemExperimentalPatients with type 1 diabetes, who initiated use of the TouchCare Nano A8 insulin pump with the APGO system.
Receives: Device: Device: Insulin pump TouchCare Nano A8 with the APGO system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in glycated haemoglobin (HbA1c)

    Differences between HbA1c values in the Visit 0 and Visit 24

    Measured: Up to 24 months

  2. 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

    Measured: Up to 24 months

Secondary outcomes (7)

  1. 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

    Measured: Up to 24 months

  2. 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

    Measured: Up to 24 months

  3. 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

    Measured: Up to 24 months

  4. Changes in average glycemia (mmol/L)

    Differences between average glycemia in the Visit 0 and Visit 24

    Measured: Up to 24 months

  5. Changes in estimated glycated haemoglobin GMI (%)

    Differences between estimated glycated haemoglobin GMI in the Visit 0 and Visit 24

    Measured: Up to 24 months

  6. Changes in glycemic variability expressed as the coefficient of variation (%)

    Differences between glycemic variability in the Visit 0 and Visit 24

    Measured: Up to 24 months

  7. Time spent in automated insulin delivery mode

    Expressed as percentage of time

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2026
  2. Study start19 Jun 2025
  3. Primary completion19 Jun 2027 (estimated)
  4. Study completion19 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07320495
Sponsor's protocol ID
RENEW
Status last verified
Dec 2025
First submitted
3 Dec 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 39065641

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

    PubMed 30070604

  • 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.

    PubMed 35367523

Questions about this trial

What is this clinical trial studying?

A study testing Device: Insulin pump TouchCare Nano A8 with the APGO system in people with Diabetes Mellitus Type 1, run by Charles University, Czech Republic at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jan Soupal (+420775654343, jan.soupal@seznam.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in glycated haemoglobin (HbA1c) (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07320495, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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