HCL in Adults With T1DM, Markedly Elevated HbA1c, and Psychological Vulnerability (NCT07509060) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
HCL in Adults With T1DM, Markedly Elevated HbA1c, and Psychological Vulnerability
Poland30 participantsStarted 2025-03-11
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Diabetes Distress Scale (DDS-17) - assesses diabetes-specific emotional distress across four domains: Emotional Burden, Physician-Related Distress, Regimen-Related Distress, and Interpersonal Distress. Scale: 1- 6. Scores ≥2.0 indicate moderate distress.
✓. Problem Areas in Diabetes (PAID) Scale - measures overall emotional burden related to diabetes. Scale: 0-100. Total scores ≥40 indicate clinically significant diabetes distress.
✓. Diabetes Burnout Questionnaire (DBQ) - evaluates emotional exhaustion, detachment from diabetes care, and perceived loss of control. Scale: 1-5. Scores \>2 suggest clinically relevant burnout symptoms.
✓. Quick Inventory of Depressive Symptomatology (QIDS) - assesses depressive symptoms over the previous week. Scale: 0-27. Scores ≥6 are considered indicative of clinically relevant depressive symptoms, with higher score ranges reflecting increasing symptom severity.
✓. Patient Health Questionnaire-9 (PHQ-9) - assesses depressive symptoms over the preceding two weeks. Scale: 0-27. Scores ≥10 indicate clinically relevant depression.
✓. Hypoglycaemia Fear Survey (HFS-II) - assesses behaviours and concerns related to hypoglycaemia; in the Polish version of the Hypoglycaemia Fear Survey-II. Scale: 0-132. Scores above 40 are commonly used to indicate elevated fear of hypoglycaemia.
✓. EQ-5D-5L (EuroQol Group, 2011) - evaluates health-related quality of life across five dimensions and includes a visual analogue scale (VAS 0-100), values below 50 considered indicative of markedly reduced perceived health status.