Feasibility and Safety Study of the Automated Insulin Delivery Closed Loop System Pancreas4ALL

NCT04835350 | Unknown DMC

• 1 other identifier: 01-CIP-27-11-20
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot prospective controlled monocentric open-label, randomized study evaluating the feasibility and safety of the Pancreas4All automated "closed loop" glycemic control system.

Conditions

Type 1 Diabetes

Keywords

closed loop system

Outcome Measures

Primary Outcomes (2)

• The feasibility of the prototype device Pancreas4ALL

  Percentage of time of automatic control of glucose by Pancreas4ALL would be \> 90%

  ten days

• The safety of the prototype device Pancreas4ALL

  Percentage of time spent in hypoglycemia 2.degrees (\<3 mmol / L) would be \< 1% during sutomatic glucose control by Pancreas4ALL

  ten days

Secondary Outcomes (2)

• GCM parametrs of glycemic control

  ten days

• Quality of life of patient living on closed loop system Pancreas4ALL

  seven days

Study Arms (3)

Hybrid closed loop group

NO INTERVENTION

Patients using AID system Pancreas4ALL in mode hybrid closed loop.

Closed loop meal announcment

EXPERIMENTAL

Patients using AID system Pancreas4ALL in mode meal announcment. They only announce what amout of carbs going to eat. They calculate no bolus

Device: Pancreas4ALL - meal announcement or full closed loop

Full closed loop

EXPERIMENTAL

Patients using AID system Pancreas4ALL in mode full closed loop. They eating with no permission and they do not calculate and sending bolus anymore.

Device: Pancreas4ALL - meal announcement or full closed loop

Interventions

Pancreas4ALL - meal announcement or full closed loop DEVICE

Patient using AID Pancreas4ALL in mode meal announcment or full closed loop.

Closed loop meal announcment; Full closed loop

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \. 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.
• \. 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

Sponsors & Collaborators

• Lenka Petruzelkova: lead
• CLOSED LOOP Systems s.r.o.: collaborator

Study Sites (1)

Department of Paediatrics, Motol University Hospital 2nd Medical Faculty in Prague, Charles University

Prague, 15006, Czechia

RECRUITING

Related Publications (1)

• Petruzelkova L, Neuman V, Plachy L, Kozak M, Obermannova B, Kolouskova S, Pruhova S, Sumnik Z. First Use of Open-Source Automated Insulin Delivery AndroidAPS in Full Closed-Loop Scenario: Pancreas4ALL Randomized Pilot Study. Diabetes Technol Ther. 2023 May;25(5):315-323. doi: 10.1089/dia.2022.0562. Epub 2023 Mar 13.

  PMID: 36826996 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lenka Petruzelkova, MD, PhD

  Department of Paediatrics, Motol University Hospital, Charles University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lenka Petruzelkova, MD, PhD

CONTACT

+420775983866; lenkapetruzelkova@gmail.com

Milos Kozak

CONTACT

+420775983866; M.Kozak@sysop.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Model Details: Pilot prospective controlled monocentric open-label, randomized study evaluating the feasibility and safety of Pancreas4All automated "closed loop" system.

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 8, 2021
• Study Start: February 19, 2021
• Primary Completion: April 30, 2021
• Study Completion: May 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 months

Locations

CZ (1)