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NCT Number: NCT07320495

Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery

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.

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Key information

Conditions

Diabetes Mellitus Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Prague, Czechia

Location status: Recruiting

Location contact

Jan Soupal

CONTACT

[email protected]

+420775654343

Jan Soupal

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device: Insulin pump TouchCare Nano A8 with the APGO system

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.

Primary outcomes

  1. Changes in glycated haemoglobin (HbA1c)

    Time frame: Up to 24 months

    Differences between HbA1c values in the Visit 0 and Visit 24

  2. Changes in percentage of time in target ranges 3,9-10,0 mmol/L (70-180 mg/dl)

    Time frame: Up to 24 months

    Differences between percentage of time in target ranges in the Visit 0 and Visit 24

Secondary outcomes

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

    Time frame: Up to 24 months

    Differences between percentage of time in hypoglycemic ranges in the Visit 0 and Visit 24

  2. Changes in percentage of time in hyperglycemic ranges >10,0 mmol/L (180 mg/dl) and >13,9 mmol/L (250 mg/dl)

    Time frame: Up to 24 months

    Differences between percentage of time in hyperglycemic ranges in the Visit 0 and Visit 24

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

    Time frame: Up to 24 months

    Differences between percentage of time in tight target ranges in the Visit 0 and Visit 24

  4. Changes in average glycemia (mmol/L)

    Time frame: Up to 24 months

    Differences between average glycemia in the Visit 0 and Visit 24

  5. Changes in estimated glycated haemoglobin GMI (%)

    Time frame: Up to 24 months

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

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

    Time frame: Up to 24 months

    Differences between glycemic variability in the Visit 0 and Visit 24

  7. Time spent in automated insulin delivery mode

    Time frame: Up to 24 months

    Expressed as percentage of time

Study contacts

Contact information is provided by the study sponsor or research team.

Dat Do

CONTACT

[email protected]

+420608220784

Jan Soupal

CONTACT

[email protected]

+420775654343

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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