NCT07509060

HCL in Adults With T1DM, Markedly Elevated HbA1c, and Psychological Vulnerability

The Impact of Introducing Hybrid Closed-loop Pump Therapy on Glucose Control, Quality of Life and Selected Chronic Complications in Type 1 Diabetes Patients With Chronically High Glucose Level and Psychological Problems

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Jerzy Hohendorff · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Estimated sample size needed to provide 80% power to detect a difference in: * in time spent in range between studied groups at 3 months, if baseline TIR is 30% and expected 60%, pooled SD of 20%,, with a two-sided significance level of 0.05, the sample is 20 (10 in each group). * in HbA1c between studied groups at 3 months, if baseline mean HbA1c is 9.5% and expected mean HbA1c is 7.5%, with pooled SD of 1.5% with a two -sided significance level of 0.05, is 20 (10 in each group) Randomization in 1:1 ratio to either mylife CamAPS FX HCL or continuation of optimised pre-study insulin therapy regimen, using the big stick method with a maximum tolerated imbalance of 3. The allocation sequence generated using the Clinical Trial Randomization Tool, and study personnel responsible for participant enrollment and assignment with no access to the randomization sequence. Funding Investigator-initiated study; device support provided by mylife Diabetes Care,, without influence on study design, analysis, or reporting. Note: The study protocol was approved by the Bioethics Committee on 29 April 2024. Registration at ClinicalTrials.gov was completed after participant enrolment had begun due to an institutional discussion within the University Hospital in Krakow regarding the registration process. This delay was caused by a discrepancy between the definition of a clinical trial under Polish law - where the term applies solely to studies involving unregistered drugs or devices - and the broader definition commonly used in the scientific community.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	mylife CamAPS FX hybrid closed-loop system	mylife CamAPS FX hybrid closed-loop system

Timeline

• Start date: 2025-03-11
• Primary completion: 2025-10-31
• Completion: 2026-09-09
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

3 sites across 1 country: Poland