Status:
UNKNOWN
Feasibility and Safety Study of the Automated Insulin Delivery Closed Loop System Pancreas4ALL
Lead Sponsor:
Lenka Petruzelkova
Collaborating Sponsors:
CLOSED LOOP Systems s.r.o.
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
15-25 years
Phase:
NA
Brief Summary
Pilot prospective controlled monocentric open-label, randomized study evaluating the feasibility and safety of the Pancreas4All automated "closed loop" glycemic control system.
Detailed Description
1. Screening - day 0 2. Hospitalization (Day 1-10) Day 1 - Deployment of study equipment, patient education Day 2 - Start of study, activation of Pancreas4ALL closed loop in mode - hybrid closed loop ...
Eligibility Criteria
Inclusion
- Subjects will be included in the study if they meet the following entry criteria:
- The subject was diagnosed with type 1 DM ≥ 1 year
- The subject is aged 15-25
- The subject has an HbA1C value between 43 mmol / mol and 75 mmol / mol at the time of the screening visit
- The subject must have experience with insulin pump therapy and CGM ≥ 3 months
- The subject is willing to use the system Pancreas4ALL continuously throughout the study
Exclusion
- 1\. The subject does not tolerate the adhesive patch at the sensor site for CGM 2. Women of productive age who have a positive pregnance test at the time of screening or are planning to become pregnant at the time of the study 4. The subject underwent the following diagnoses in the year preceding screening: myocardial infarction, unstable angina pectoris, coronary artery bypass passage, stent insertion into the coronary artery, transient ischemic attack, cerebrovascular accident, angina pectoris, congestive heart failure, ventricular arrhythmia or thromboembolism 5. The subject has an abnormal (\> 1.5x times the upper reference limit, as assessed by the laboratory) creatinine at the time of screening 6. The subject has clinically significant abnormalities (outside the reference range as assessed by the laboratory) of thyroid stimulating hormone (TSH) at the time of screening 7. The subject has taken any oral or injectable corticosteroids in the last 8 weeks prior to the screening visit, or plans to take any oral or injectable corticosteroids during the study 8. The subject is actively involved in any research study (drug or instrumental) in which he or she has undergone treatment with a research drug or research facility in the previous 2 weeks prior to the screening visit.
- 9\. The subject is currently using illicit drugs 10. The subject is currently abusing prescription drugs 11. The subject is currently addicted to alcohol 12. The subject is taking pramlintide (Symlin) or an SGLT2 inhibitor at the time of the screening visit 13. The subject suffers from a visual impairment that does not allow him to participate in the study and to safely perform all tasks within the study, as determined by the investigator 14. The subject has planned elective surgery requiring general anesthesia for the duration of the study 15. The subject has currently been diagnosed with an eating disorder such as anorexia or bulimia 16. The subject has been diagnosed with chronic renal failure leading to chronic anemia 17. The subject is dialyzed
Key Trial Info
Start Date :
February 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04835350
Start Date
February 19 2021
End Date
May 1 2021
Last Update
April 8 2021
Active Locations (1)
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1
Department of Paediatrics, Motol University Hospital 2nd Medical Faculty in Prague, Charles University
Prague, Czechia, 15006