Diabetes Mellitus Type 1
Conditions
Keywords
automated insulin delivery system, patch pump
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.
Interventions
DEVICEDevice: Insulin pump TouchCare Nano A8 with the APGO system
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.
Sponsors
Charles University, Czech Republic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in glycated haemoglobin (HbA1c) | Up to 24 months | Differences between HbA1c values in the Visit 0 and Visit 24 |
| Changes in percentage of time in target ranges 3,9-10,0 mmol/L (70-180 mg/dl) | Up to 24 months | Differences between percentage of time in target ranges in the Visit 0 and Visit 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in percentage of time in tight target ranges 3,9-7,8 mmol/L (70-140 mg/dl) | Up to 24 months | Differences between percentage of time in tight target ranges in the Visit 0 and Visit 24 |
| Changes in average glycemia (mmol/L) | Up to 24 months | Differences between average glycemia in the Visit 0 and Visit 24 |
| 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 | Differences between percentage of time in hypoglycemic ranges in the Visit 0 and Visit 24 |
| Changes in glycemic variability expressed as the coefficient of variation (%) | Up to 24 months | Differences between glycemic variability in the Visit 0 and Visit 24 |
| Time spent in automated insulin delivery mode | Up to 24 months | Expressed as percentage of time |
| Changes in estimated glycated haemoglobin GMI (%) | Up to 24 months | Differences between estimated glycated haemoglobin GMI in the Visit 0 and Visit 24 |
| 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 | Differences between percentage of time in hyperglycemic ranges in the Visit 0 and Visit 24 |
Countries
Czechia
Contacts
Primary ContactJan Soupal
Backup ContactDat Do
Outcome results
None listed