Type 1 Diabetes MellitusHi-LoopNCT07509060
HCL in Adults With T1DM, Markedly Elevated HbA1c, and Psychological Vulnerability
A study testing mylife CamAPS FX hybrid closed-loop system in people with Type 1 Diabetes Mellitus, run by Jerzy Hohendorff at 3 sites in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- mylife CamAPS FX hybrid closed-loop system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesPoland
- Study dates
- 11 Mar 2025to 9 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
Medical University of Silesia in Katowice, Poland
Katowice
University Hospital in Krakow
Krakow
Poznan University of Medical Science, Poland
Poznan
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- mylife CamAPS FX hybrid closed-loop system
- Keywords
- T1DM, HCL, TIR, CamAPS FX, Psychological problems
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mylife CamAPS FX hybrid closed-loop systemDevice
mylife CamAPS FX hybrid closed-loop system
| Study group | Role | What they receive |
|---|---|---|
| mylife CamAPS FX hybrid closed-loop | Experimental | mylife CamAPS FX HCL after randomization for 12 months Receives: Device: mylife CamAPS FX hybrid closed-loop system |
| Control | No intervention | Standard therapy for 3 months after randomization, and mylife CamAPS FX HCL for next 9 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Between-group difference in HbA1c change after 3 months of follow-up
Measured: 3 months
Time in range 70-180 mg/dL
Between-group difference in TIR change after 3 months of follow-up
Measured: 3 months
Secondary outcomes (36)
Mean glucose
Between-group difference in mean glucose change after 3 months of follow-up
Measured: 3 months
Glucose management index (GMI)
Between-group difference in GMI change after 3 months of follow-up
Measured: 3 months
Time below range <70 mg/dL (TB70)
Between-group difference in TB70 change after 3 months of follow-up
Measured: 3 months
Time below range <54 mg/dL (TB54)
Between-group difference in TB54 change after 3 months of follow-up
Measured: 3 months
Time above range >180 mg/dL (TA180)
Between-group difference in TA180 change after 3 months of follow-up
Measured: 3 months
Time above range >250 mg/dL (TA250)
Between-group difference in TA250 change after 3 months of follow-up
Measured: 3 months
Glucose variability
Between-group difference in coefficient of variation (CV) change after 3 months of follow-up
Measured: 3 months
Time in tight range 70-140 mg/dL (TITR)
Between-group difference in TITR change after 3 months of follow-up
Measured: 3 months
HbA1c
Change in HbA1c within entire group from baseline after 12 months of follow-up
Measured: 12 months
TIR
Change in TIR within entire group from baseline after 12 months of follow-up
Measured: 12 months
Mean glucose
Change in mean glucose within entire group from baseline after 12 months of follow-up
Measured: 12 months
GMI
Change in GMI within entire group from baseline after 12 months of follow-up
Measured: 12 months
TB70
Change in TB70 within entire group from baseline after 12 months of follow-up
Measured: 12 months
TB54
Change in TB54 within entire group from baseline after 12 months of follow-up
Measured: 12 months
TA180
Change in TA180 within entire group from baseline after 12 months of follow-up
Measured: 12 months
TA250
Change in TA250 within entire group from baseline after 12 months of follow-up
Measured: 12 months
Glucose variability
Change in CV within entire group from baseline after 12 months of follow-up
Measured: 12 months
TITR
Change in TITR within entire group from baseline after 12 months of follow-up
Measured: 12 months
Diabetes Distress Scale (DDS-17)
Within group change in DDS-17 from baseline after 3 months of follow-up
Measured: 3 months
Diabetes Distress Scale (DDS-17)
Within entire group change in DDS-17 from baseline after 12 months of follow-up
Measured: 12 months
Problem Areas in Diabetes (PAID) Scale
Within group change in PAID from baseline after 3 months of follow-up
Measured: 3 months
PAID
Within entire group change in PAID from baseline after 12 months of follow-up
Measured: 12 months
Diabetes Burnout Questionnaire (DBQ)
Within group change in DBQ from baseline after 3 months of follow-up
Measured: 3 months
Diabetes Burnout Questionnaire (DBQ)
Within entire group change in DBQ from baseline after 12 months of follow-up
Measured: 12 months
Quick Inventory of Depressive Symptomatology (QIDS)
Within group change in QIDS from baseline after 3 months of follow-up
Measured: 3 months
Quick Inventory of Depressive Symptomatology (QIDS)
Within entire group change in QIDS from baseline after 12 months of follow-up
Measured: 12 months
Patient Health Questionnaire-9 (PHQ-9)
Within group change in PHQ-9 from baseline after 3 months of follow-up
Measured: 3 months
Patient Health Questionnaire-9 (PHQ-9)
Within entire group change in PHQ-9 from baseline after 12 months of follow-up
Measured: 12 months
WHO-5 Well-Being Index
Within group change in WHO-5 from baseline after 3 months of follow-up
Measured: 3 months
WHO-5 Well-Being Index
Within entire group change in WHO-5 from baseline after 12 months of follow-up
Measured: 12 months
Hypoglycaemia Fear Survey (HFS-II)
Within group change in HFS-II from baseline after 3 months of follow-up
Measured: 3 months
Hypoglycaemia Fear Survey (HFS-II)
Within entire group change in HFS-II from baseline after 12 months of follow-up
Measured: 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
Measured: 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
Measured: 12 months
Symptom Questionnaire (KO "0")
Within group change in KO "0" from baseline after 3 months of follow-up
Measured: 3 months
Symptom Questionnaire (KO "0")
Within entire group change in KO "0" from baseline after 12 months of follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start11 Mar 2025
- Primary completion31 Oct 2025
- Study completion9 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, prospective, randomized, controlled, open-label, partial cross-over
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jerzy Hohendorff
- Sponsor type
- University, hospital or other
- Collaborators
- mylife Diabetes Care AG
- Responsible party
- Sponsor-investigator, Jerzy Hohendorff, Jagiellonian University
- Investigators
- Tomasz Klupa, MD, PhD, Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509060
- Sponsor's protocol ID
- Hi-Loop
- Acronym
- Hi-Loop
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data collected during the study will be made available upon reasonable request after completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07509060
- Acronym / sponsor ID
- Hi-Loop / Hi-Loop
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- T1DM, HCL, TIR, CamAPS FX, Psychological problems
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jerzy HohendorffUniversity, hospital or other
- Collaborators
- mylife Diabetes Care AG
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 9 Sep 2026 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, prospective, randomized, controlled, open-label, partial cross-over
| Arm | Type | Receives |
|---|---|---|
| mylife CamAPS FX hybrid closed-loop | Experimental | Device: mylife CamAPS FX hybrid closed-loop systemmylife CamAPS FX HCL after randomization for 12 months |
| Control | No intervention | –Standard therapy for 3 months after randomization, and mylife CamAPS FX HCL for next 9 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mylife CamAPS FX hybrid closed-loop systemmylife CamAPS FX hybrid closed-loop system | Device | mylife CamAPS FX hybrid closed-loop |
Primary outcome
HbA1c
Time frame: 3 months
Between-group difference in HbA1c change after 3 months of follow-up
Time in range 70-180 mg/dL
Time frame: 3 months
Between-group difference in TIR change after 3 months of follow-up
36 secondary outcomes
Mean glucose
Time frame: 3 months
Glucose management index (GMI)
Time frame: 3 months
Time below range <70 mg/dL (TB70)
Time frame: 3 months
Time below range <54 mg/dL (TB54)
Time frame: 3 months
Time above range >180 mg/dL (TA180)
Time frame: 3 months
Time above range >250 mg/dL (TA250)
Time frame: 3 months
Glucose variability
Time frame: 3 months
Time in tight range 70-140 mg/dL (TITR)
Time frame: 3 months
HbA1c
Time frame: 12 months
TIR
Time frame: 12 months
Mean glucose
Time frame: 12 months
GMI
Time frame: 12 months
TB70
Time frame: 12 months
TB54
Time frame: 12 months
TA180
Time frame: 12 months
TA250
Time frame: 12 months
Glucose variability
Time frame: 12 months
TITR
Time frame: 12 months
Diabetes Distress Scale (DDS-17)
Time frame: 3 months
Diabetes Distress Scale (DDS-17)
Time frame: 12 months
Problem Areas in Diabetes (PAID) Scale
Time frame: 3 months
PAID
Time frame: 12 months
Diabetes Burnout Questionnaire (DBQ)
Time frame: 3 months
Diabetes Burnout Questionnaire (DBQ)
Time frame: 12 months
Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: 3 months
Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: 12 months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 3 months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12 months
WHO-5 Well-Being Index
Time frame: 3 months
WHO-5 Well-Being Index
Time frame: 12 months
Hypoglycaemia Fear Survey (HFS-II)
Time frame: 3 months
Hypoglycaemia Fear Survey (HFS-II)
Time frame: 12 months
EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS)
Time frame: 3 months
EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS)
Time frame: 12 months
Symptom Questionnaire (KO "0")
Time frame: 3 months
Symptom Questionnaire (KO "0")
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Yes. The data collected during the study will be made available upon reasonable request after completion of the study.
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Klupa, MD, PhD principal investigator
Jagiellonian University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mylife CamAPS FX hybrid closed-loop system in people with Type 1 Diabetes Mellitus, run by Jerzy Hohendorff at 3 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.