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

N/AActive Not RecruitingNCT07509060

Jerzy Hohendorff30 enrolled

Overview

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

HbA1c

Between-group difference in HbA1c change after 3 months of follow-up

Time frame: 3 months

Time in range 70-180 mg/dL

Between-group difference in TIR change after 3 months of follow-up

Time frame: 3 months

Secondary Outcomes

Mean glucose

Between-group difference in mean glucose change after 3 months of follow-up

Time frame: 3 months

Glucose management index (GMI)

Between-group difference in GMI change after 3 months of follow-up

Time frame: 3 months

Time below range <70 mg/dL (TB70)

Between-group difference in TB70 change after 3 months of follow-up

Time frame: 3 months

Time below range <54 mg/dL (TB54)

Between-group difference in TB54 change after 3 months of follow-up

Time frame: 3 months

Time above range >180 mg/dL (TA180)

Between-group difference in TA180 change after 3 months of follow-up

Time frame: 3 months

Time above range >250 mg/dL (TA250)

Between-group difference in TA250 change after 3 months of follow-up

Time frame: 3 months

Glucose variability

Between-group difference in coefficient of variation (CV) change after 3 months of follow-up

Time frame: 3 months

Time in tight range 70-140 mg/dL (TITR)

Between-group difference in TITR change after 3 months of follow-up

Time frame: 3 months

HbA1c

Change in HbA1c within entire group from baseline after 12 months of follow-up

Time frame: 12 months

TIR

Change in TIR within entire group from baseline after 12 months of follow-up

Time frame: 12 months

Mean glucose

Change in mean glucose within entire group from baseline after 12 months of follow-up

Time frame: 12 months

GMI

Change in GMI within entire group from baseline after 12 months of follow-up

Time frame: 12 months

TB70

Change in TB70 within entire group from baseline after 12 months of follow-up

Time frame: 12 months

TB54

Change in TB54 within entire group from baseline after 12 months of follow-up

Time frame: 12 months

TA180

Change in TA180 within entire group from baseline after 12 months of follow-up

Time frame: 12 months

TA250

Change in TA250 within entire group from baseline after 12 months of follow-up

Time frame: 12 months

Glucose variability

Change in CV within entire group from baseline after 12 months of follow-up

Time frame: 12 months

TITR

Change in TITR within entire group from baseline after 12 months of follow-up

Time frame: 12 months

Diabetes Distress Scale (DDS-17)

Within group change in DDS-17 from baseline after 3 months of follow-up

Time frame: 3 months

Diabetes Distress Scale (DDS-17)

Within entire group change in DDS-17 from baseline after 12 months of follow-up

Time frame: 12 months

Problem Areas in Diabetes (PAID) Scale

Within group change in PAID from baseline after 3 months of follow-up

Time frame: 3 months

PAID

Within entire group change in PAID from baseline after 12 months of follow-up

Time frame: 12 months

Diabetes Burnout Questionnaire (DBQ)

Within group change in DBQ from baseline after 3 months of follow-up

Time frame: 3 months

Diabetes Burnout Questionnaire (DBQ)

Within entire group change in DBQ from baseline after 12 months of follow-up

Time frame: 12 months

Quick Inventory of Depressive Symptomatology (QIDS)

Within group change in QIDS from baseline after 3 months of follow-up

Time frame: 3 months

Quick Inventory of Depressive Symptomatology (QIDS)

Within entire group change in QIDS from baseline after 12 months of follow-up

Time frame: 12 months

Patient Health Questionnaire-9 (PHQ-9)

Within group change in PHQ-9 from baseline after 3 months of follow-up

Time frame: 3 months

Patient Health Questionnaire-9 (PHQ-9)

Within entire group change in PHQ-9 from baseline after 12 months of follow-up

Time frame: 12 months

WHO-5 Well-Being Index

Within group change in WHO-5 from baseline after 3 months of follow-up

Time frame: 3 months

WHO-5 Well-Being Index

Within entire group change in WHO-5 from baseline after 12 months of follow-up

Time frame: 12 months

Hypoglycaemia Fear Survey (HFS-II)

Within group change in HFS-II from baseline after 3 months of follow-up

Time frame: 3 months

Hypoglycaemia Fear Survey (HFS-II)

Within entire group change in HFS-II from baseline after 12 months of follow-up

Time frame: 12 months

EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS)

Within group change in EQ-5D-5L VAS from baseline after 3 months of follow-up

Time frame: 3 months

EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS)

Within entire group change in EQ-5D-5L VAS from baseline after 12 months of follow-up

Time frame: 12 months

Symptom Questionnaire (KO "0")

Within group change in KO "0" from baseline after 3 months of follow-up

Time frame: 3 months

Symptom Questionnaire (KO "0")

Within entire group change in KO "0" from baseline after 12 months of follow-up

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes