U.S., April 4 -- ClinicalTrials.gov registry received information related to the study (NCT07509060) titled 'HCL in Adults With T1DM, Markedly Elevated HbA1c, and Psychological Vulnerability' on March 23.
Brief 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 ...