HCL in Adults With T1DM, Markedly Elevated HbA1c, and Psychological Vulnerability (Hi-Loop)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: mylife CamAPS FX hybrid closed-loop system

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Katowice, Poland
    • Medical University of Silesia in Katowice, Poland
  • Krakow, Poland
    • University Hospital in Krakow
  • Poznan, Poland
    • Poznan University of Medical Science, Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mylife CamAPS FX hybrid closed-loop; mylife CamAPS FX HCL after randomization for 12 months	Device: mylife CamAPS FX hybrid closed-loop system; mylife CamAPS FX hybrid closed-loop system
No Intervention: Control; Standard therapy for 3 months after randomization, and mylife CamAPS FX HCL for next 9 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Between-group difference in HbA1c change after 3 months of follow-up	3 months
Time in range 70-180 mg/dL	Between-group difference in TIR change after 3 months of follow-up	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean glucose	Between-group difference in mean glucose change after 3 months of follow-up	3 months
Glucose management index (GMI)	Between-group difference in GMI change after 3 months of follow-up	3 months
Time below range <70 mg/dL (TB70)	Between-group difference in TB70 change after 3 months of follow-up	3 months
Time below range <54 mg/dL (TB54)	Between-group difference in TB54 change after 3 months of follow-up	3 months
Time above range >180 mg/dL (TA180)	Between-group difference in TA180 change after 3 months of follow-up	3 months
Time above range >250 mg/dL (TA250)	Between-group difference in TA250 change after 3 months of follow-up	3 months
Glucose variability	Between-group difference in coefficient of variation (CV) change after 3 months of follow-up	3 months
Time in tight range 70-140 mg/dL (TITR)	Between-group difference in TITR change after 3 months of follow-up	3 months
HbA1c	Change in HbA1c within entire group from baseline after 12 months of follow-up	12 months
TIR	Change in TIR within entire group from baseline after 12 months of follow-up	12 months
Mean glucose	Change in mean glucose within entire group from baseline after 12 months of follow-up	12 months
GMI	Change in GMI within entire group from baseline after 12 months of follow-up	12 months
TB70	Change in TB70 within entire group from baseline after 12 months of follow-up	12 months
TB54	Change in TB54 within entire group from baseline after 12 months of follow-up	12 months
TA180	Change in TA180 within entire group from baseline after 12 months of follow-up	12 months
TA250	Change in TA250 within entire group from baseline after 12 months of follow-up	12 months
Glucose variability	Change in CV within entire group from baseline after 12 months of follow-up	12 months
TITR	Change in TITR within entire group from baseline after 12 months of follow-up	12 months
Diabetes Distress Scale (DDS-17)	Within group change in DDS-17 from baseline after 3 months of follow-up	3 months
Diabetes Distress Scale (DDS-17)	Within entire group change in DDS-17 from baseline after 12 months of follow-up	12 months
Problem Areas in Diabetes (PAID) Scale	Within group change in PAID from baseline after 3 months of follow-up	3 months
PAID	Within entire group change in PAID from baseline after 12 months of follow-up	12 months
Diabetes Burnout Questionnaire (DBQ)	Within group change in DBQ from baseline after 3 months of follow-up	3 months
Diabetes Burnout Questionnaire (DBQ)	Within entire group change in DBQ from baseline after 12 months of follow-up	12 months
Quick Inventory of Depressive Symptomatology (QIDS)	Within group change in QIDS from baseline after 3 months of follow-up	3 months
Quick Inventory of Depressive Symptomatology (QIDS)	Within entire group change in QIDS from baseline after 12 months of follow-up	12 months
Patient Health Questionnaire-9 (PHQ-9)	Within group change in PHQ-9 from baseline after 3 months of follow-up	3 months
Patient Health Questionnaire-9 (PHQ-9)	Within entire group change in PHQ-9 from baseline after 12 months of follow-up	12 months
WHO-5 Well-Being Index	Within group change in WHO-5 from baseline after 3 months of follow-up	3 months
WHO-5 Well-Being Index	Within entire group change in WHO-5 from baseline after 12 months of follow-up	12 months
Hypoglycaemia Fear Survey (HFS-II)	Within group change in HFS-II from baseline after 3 months of follow-up	3 months
Hypoglycaemia Fear Survey (HFS-II)	Within entire group change in HFS-II from baseline after 12 months of follow-up	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	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	12 months
Symptom Questionnaire (KO "0")	Within group change in KO "0" from baseline after 3 months of follow-up	3 months
Symptom Questionnaire (KO "0")	Within entire group change in KO "0" from baseline after 12 months of follow-up	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe hypoglycemic episodes	Severe hypoglycemic episodes defined as requiring medical assistance	3 months
Severe hypoglycemic episodes	Severe hypoglycemic episodes defined as requiring medical assistance	12 months
Severe hypoglycemic episodes	Severe hypoglycemic episodes defined as requiring other third party assistance	3 months
Severe hypoglycemic episodes	Severe hypoglycemic episodes defined as requiring other third party assistance	12 months
Non-severe hypoglycemic episodes below 54 mg/dl	Non-severe hypoglycemic episodes below 54 mg/dl longer than 15 min duration	3 months
Non-severe hypoglycemic episodes below 54 mg/dl	Non-severe hypoglycemic episodes below 54 mg/dl longer than 15 min duration	12 months
Diabetes ketoacidosis (DKA)	Hospitalization due to DKA	3 months
Diabetes ketoacidosis (DKA)	Hospitalization due to DKA	12 months

Collaborators and Investigators

• Sponsor: Jerzy Hohendorff
• Collaborators: mylife Diabetes Care AG
• Investigators: Principal Investigator: Tomasz Klupa, MD, PhD, Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2025
• Primary Completion (Actual): October 31, 2025
• Study Completion (Estimated): September 9, 2026

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: T1DM; HCL; TIR; Psychological problems; CamAPS FX
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: HI-LOOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data collected during the study will be made available upon reasonable request after completion of the study.
• IPD Sharing Time Frame: 10 years
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No