Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery
ConditionDiabetes Mellitus Type 1
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharles University, Czech Republic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with T1D
type 1 diabetes for ≥1 years
≥ 18 years old
written informed consent prior to starting study related activity
Disqualifiers
severe noncompliance
lactation, pregnancy, intending to become pregnant during study
use of medication with effects on carbohydrate metabolism
Trial design
Design model
Single group
Treatments tested in this trial
Device: Insulin pump TouchCare Nano A8 with the APGO system
DeviceInsulin pump Medtrum TouchCare Nano A8 with the APGO algorithm is the only patch pump-based automated insulin delivery system available in the Czech Republic.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Patients with TouchCare Nano A8 insulin pump with the APGO systemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in glycated haemoglobin (HbA1c)
Differences between HbA1c values in the Visit 0 and Visit 24
Time frame
Up to 24 months2
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 monthsSecondary 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)
Differences between percentage of time in hypoglycemic ranges in the Visit 0 and Visit 24
Time frame
Up to 24 months2
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 months3
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 months4
Changes in average glycemia (mmol/L)
Differences between average glycemia in the Visit 0 and Visit 24
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov