Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Device: Insulin pump TouchCare Nano A8 with the APGO system.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus Type 1. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery: The RENEW Study
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.
Interventions
- Device Device: 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.
Primary outcome measures
- Changes in glycated haemoglobin (HbA1c) [Time frame: Up to 24 months]
- Changes in percentage of time in target ranges 3,9-10,0 mmol/L (70-180 mg/dl) [Time frame: Up to 24 months]
Secondary outcome measures (7)
- 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]
- 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]
- 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]
- Changes in average glycemia (mmol/L) [Time frame: Up to 24 months]
- Changes in estimated glycated haemoglobin GMI (%) [Time frame: Up to 24 months]
- Changes in glycemic variability expressed as the coefficient of variation (%) [Time frame: Up to 24 months]
- Time spent in automated insulin delivery mode [Time frame: Up to 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Czechia · 1 center
- 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, — Prague
Publications
- 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. PMID 39065641
- Ginsberg BH. Patch Pumps for Insulin. J Diabetes Sci Technol. 2019 Jan;13(1):27-33. doi: 10.1177/1932296818786513. Epub 2018 Aug 2. PMID 30070604
- 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. PMID 35367523
Identifiers
NCT: NCT07320495 · RENEW