Smart pump trial aims to tame tough diabetes cases

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. 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. 2. Problem Areas in Diabetes (PAID) Scale - measures overall emotional burden related to diabetes. Scale: 0-100. Total scores ≥40 indicate clinically significant diabetes distress. 3. 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. 4. 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. 5. Patient Health Questionnaire-9 (PHQ-9) - assesses depressive symptoms over the preceding two weeks. Scale: 0-27. Scores ≥10 indicate clinically relevant depression. 6. WHO-5 Well-Being Index - measures positive well-being. Scale: 0-25. Scores ≤13 indicate reduced well-being. 7. 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. 8. 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. 9. 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. Exclusion Criteria: * Current treatment with hybrid closed loop system. * Daily dose of insulin \>300 IU. * Known or suspected contact allergy to the pump cannula or adhesives. * Pregnancy or planning pregnancy, breast feeding. * Renal impairment on dialysis. * Proliferative, uncontrolled retinopathy. * Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids. * 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. * Patients not able to follow study instructions as judged by the investigator