Last reviewed · How we verify
NCT07509060: Hi-Loop
HCL in Adults With T1DM, Markedly Elevated HbA1c, and Psychological Vulnerability
NA trial testing mylife CamAPS FX hybrid closed-loop system in Type 1 Diabetes Mellitus in 30 participants. Participants enrolled and being followed up; not accepting new ones.
31 October 2025
Quick facts
| Lead sponsor | Jerzy Hohendorff |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 11 March 2025 |
| Primary completion | 31 October 2025 |
| Estimated completion | 9 September 2026 |
| Sites | 3 locations across Poland |
Drugs / interventions tested
- mylife CamAPS FX hybrid closed-loop system
Conditions studied
- Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →
Sponsor
Jerzy Hohendorff
Who can join
Adults 18 to 65, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to evaluate whether the mylife CamAPS FX hybrid closed loop (HCL) system improves glycemic control and quality of life in type 1 diabetes (T1DM) patients with a chronic lack of glycemic control and with psychological problems. After screening visit and run-in, patients will be randomized to treatment with mylife CamAPS FX HCL for 12 months (group I) or treatment with their current type of treatment for 3 months and mylife CamAPS FX HCL for next 9 months (group II). The HCL system used in the study will consist of mylife CamAPS FX controller, mylife YpsoPump insulin pump and Dexcom G6 continuous glucose monitoring system (CGM). Main inclusion criteria include: type 1 diabetes for at least 2 years, hemoglobin A1c (HbA1c) ≥ 9.0%, and psychological vulnerability. Primary glycemic outcomes include: differences between study groups in changes in time in range 70-180 mg/dL (TIR) and HbA1c after 3 months. Main secondary outcomes include: differences between groups in CGM-derived data after 3 months and within the entire cohort after 12 months, as well as changes within groups in psychological scores after 3 months and within the entire cohort after 12 months.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07509060
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Type 1 Diabetes Mellitus
Currently open trials in the same condition.
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- NCT07296276 — Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM · NA · recruiting
- NCT07409701 — Gamification Intervertion in Children With Type 1 Diabetes · NA · recruiting
- NCT07356089 — Twiist Postmarket Surveillance Study for Type 1 Diabetes · recruiting
- NCT07434154 — Evaluation of Oxidative Stress: Comparison Between Type 1 Diabetes Mellitus and Latent Autoimmune Diabetes in Adults · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07509060 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jerzy Hohendorff
- Last refreshed: 3 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07509060.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing