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

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

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.

Estimated sample size needed to provide 80% power to detect a difference in:

• in time spent in range between studied groups at 3 months, if baseline TIR is 30% and expected 60%, pooled SD of 20%,, with a two-sided significance level of 0.05, the sample is 20 (10 in each group).
• in HbA1c between studied groups at 3 months, if baseline mean HbA1c is 9.5% and expected mean HbA1c is 7.5%, with pooled SD of 1.5% with a two -sided significance level of 0.05, is 20 (10 in each group)

Randomization in 1:1 ratio to either mylife CamAPS FX HCL or continuation of optimised pre-study insulin therapy regimen, using the big stick method with a maximum tolerated imbalance of 3. The allocation sequence generated using the Clinical Trial Randomization Tool, and study personnel responsible for participant enrollment and assignment with no access to the randomization sequence.

Funding Investigator-initiated study; device support provided by mylife Diabetes Care,, without influence on study design, analysis, or reporting.

Note: The study protocol was approved by the Bioethics Committee on 29 April 2024. Registration at ClinicalTrials.gov was completed after participant enrolment had begun due to an institutional discussion within the University Hospital in Krakow regarding the registration process. This delay was caused by a discrepancy between the definition of a clinical trial under Polish law - where the term applies solely to studies involving unregistered drugs or devices - and the broader definition commonly used in the scientific community.

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