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ACTIVE NOT RECRUITING
NCT07509060
NA

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

Sponsor: Jerzy Hohendorff

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-03-11

Completion Date

2026-09-09

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DEVICE

mylife CamAPS FX hybrid closed-loop system

mylife CamAPS FX hybrid closed-loop system

Locations (3)

Medical University of Silesia in Katowice, Poland

Katowice, Poland

University Hospital in Krakow

Krakow, Poland

Poznan University of Medical Science, Poland

Poznan, Poland