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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with TouchCare Nano A8 insulin pump with the APGO system | Experimental | Patients with type 1 diabetes, who initiated use of the TouchCare Nano A8 insulin pump with the APGO system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in glycated haemoglobin (HbA1c) | Differences between HbA1c values in the Visit 0 and Visit 24 | 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 | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Soupal | Contact | +420775654343 | jan.soupal@seznam.cz | |
| Dat Do | Contact | +420608220784 | datdoquoc@seznam.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czechia | Recruiting | Prague | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39065641 | Result | 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. | |
| 30070604 | Result | Ginsberg BH. Patch Pumps for Insulin. J Diabetes Sci Technol. 2019 Jan;13(1):27-33. doi: 10.1177/1932296818786513. Epub 2018 Aug 2. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Differences between percentage of time in hyperglycemic ranges in the Visit 0 and Visit 24 |
| 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 | Up to 24 months |
| Changes in average glycemia (mmol/L) | Differences between average glycemia in the Visit 0 and Visit 24 | Up to 24 months |
| Changes in estimated glycated haemoglobin GMI (%) | Differences between estimated glycated haemoglobin GMI in the Visit 0 and Visit 24 | Up to 24 months |
| Changes in glycemic variability expressed as the coefficient of variation (%) | Differences between glycemic variability in the Visit 0 and Visit 24 | Up to 24 months |
| Time spent in automated insulin delivery mode | Expressed as percentage of time | Up to 24 months |
| 35367523 | Result | 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |