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

Korábbi kezelés

• Current treatment with hybrid closed loop system.

Más betegség

• Known or suspected contact allergy to the pump cannula or adhesives.
• Renal impairment on dialysis.
• Known severe mental disorders (schizophrenia, psychotic episodes, bipolar disorder, dementia, drugs and alcohol abuse, eating disorders - anorexia, bulimia, learning disabilities, depression with active suicidal ideation) which are likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator.

Laborértékek

• Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids.

Egyéb

• Daily dose of insulin >300 IU.
• Pregnancy or planning pregnancy, breast feeding.
• Proliferative, uncontrolled retinopathy.
• Patients not able to follow study instructions as judged by the investigator

• Age 18 - 65 years at time of screening
• A clinical diagnosis of type 1 diabetes for 2 years or more as determined by the medical record or other source documentation by a health care professional qualified to make a diagnosis.
• HbA1c of >= 9.0% in last 6 months.
• Multiple daily injections or insulin pump therapy with or without CGM, except HCL
• Total daily insulin 5 U/day - 300 U/day
• Adequate hearing to hear alarms and adequate vision to view display
• Willing to follow study specific instructions and improve glucose control.
• Willing to use CamAPS FX continuously throughout the study.
• Female participants of child-bearing age should be on effective contraception and must have a negative urine-HCG pregnancy test at screening
• Psychological problems defined as one of the following:
  • 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.
  • WHO-5 Well-Being Index - measures positive well-being. Scale: 0-25. Scores ≤13 indicate reduced well-being.
  • 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.
  • Symptom Questionnaire (KO "0") - used to assess anxiety-related psychological symptoms. Scale: 0-336. Scores above normative thresholds (180 for males, 200 for females) indicate clinically relevant anxiety symptomatology.