APGO automated insulin delivery with the TouchCare Nano patch pump for adults with type 1 diabetes
Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery: The RENEW Study
This study will test whether the APGO algorithm in the Medtrum TouchCare Nano patch pump improves blood glucose control and is safe for adults with type 1 diabetes in everyday use.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charles University, Czech Republic Academic / other |
| Locations | 1 site (Prague) |
| Trial ID | NCT07320495 on ClinicalTrials.gov |
What this trial studies
The RENEW study is a prospective interventional trial of the Medtrum TouchCare Nano patch pump running the APGO automated insulin delivery algorithm in real-world conditions. Adults with type 1 diabetes for at least one year who are 18 or older and able to give informed consent will use the device while researchers record glucose metrics, insulin delivery data, and adverse events. Key exclusions include pregnancy or lactation, severe noncompliance, and use of medications that affect carbohydrate metabolism. The study is conducted at the 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University in Prague to provide practical safety and effectiveness data for this patch-pump AID system.
Who should consider this trial
Good fit: Adults (≥18 years) with type 1 diabetes for at least one year who can give informed consent and are willing to use the TouchCare Nano system.
Not a fit: People who are pregnant or breastfeeding, those taking medications that affect carbohydrate metabolism, or individuals with severe noncompliance are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the APGO-powered patch pump could provide safer, more stable glucose control and simpler insulin delivery for adults with type 1 diabetes.
How similar studies have performed: Automated insulin delivery systems in general have shown improved time-in-range and reduced hypoglycemia in trials, but prospective real-world evidence specifically for the APGO algorithm on a patch pump is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Prague
- 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czechia — Prague, Czechia (Recruiting)
Study contacts
- Study coordinator: Jan Soupal
- Email: jan.soupal@seznam.cz
- Phone: +420775654343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.