Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery

N/ARecruitingNCT07320495

Charles University, Czech Republic200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Diabetes Mellitus Type 1

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Prague, Czechia

RECRUITING

Outcomes

Primary Outcomes

Changes in glycated haemoglobin (HbA1c)

Differences between HbA1c values in the Visit 0 and Visit 24

Time frame: 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

Time frame: Up to 24 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Up to 24 months

Changes in average glycemia (mmol/L)

Differences between average glycemia in the Visit 0 and Visit 24

Time frame: Up to 24 months

Changes in estimated glycated haemoglobin GMI (%)

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

Time frame: Up to 24 months

Central Contacts

Jan Soupal

CONTACT

+420775654343 jan.soupal@seznam.cz

Dat Do

CONTACT

+420608220784 datdoquoc@seznam.cz

Data from ClinicalTrials.gov

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