Type 1 DiabetesASAPNCT04835350
Feasibility and Safety Study of the Automated Insulin Delivery Closed Loop System Pancreas4ALL
A study testing Pancreas4ALL - meal announcement or full closed loop in people with Type 1 Diabetes, run by Lenka Petruzelkova at 1 site in Czechia.
Trial summary
Pilot prospective controlled monocentric open-label, randomized study evaluating the feasibility and safety of the Pancreas4All automated "closed loop" glycemic control system. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Pancreas4ALL - meal announcement or full closed loop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCzechia
- Study dates
- 19 Feb 2021to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Department of Paediatrics, Motol University Hospital 2nd Medical Faculty in Prague, Charles University
Prague, 15006
Lenka Petruzelkova, MD, PhD, +420775983866, lenkapetruzelkova@gmail.com
About this study
Official title: Feasibility Study of the Pancreas4ALL Closed-loop Automated Glycemic Control System in Patients With Type 1 Diabetes Mellitus: Pancreas4ALL Project - Good News Study - Phase I
Pilot prospective controlled monocentric open-label, randomized study evaluating the feasibility and safety of the Pancreas4All automated "closed loop" glycemic control system.
Read the detailed description
- Screening - day 0
- 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 (2.7.1) Day 4 - Randomization of patients to Group A and to Group B Group A - Activation of Pancreas4ALL closed loop in closed loop mode - "food announcement" (2.7.2) Group B - Activation of Pancreas4ALL closed loop in mode - full closed loop mode (2.7.3) Day 7 - Crossover - Group exchange Day 10 - Return to the initial treatment modality.
- Termination of the study
Detailed description of the clinical trial - study control plan:
Outpatient check:
- Signing of informed consents to the study and GDPR consent to the processing of personal data by the legal representative and the entity that will be included in the study
- Urine pregnancy test for women and girls after menarche
- Blood collection for the determination of HbA1c, TSH and creatinine
- Evaluation of entry criteria (inclusion criteria); if all criteria are met, the subject will be included in the study.
Day 1:
- Hospitalization in the inpatient part of the University Hospital and the 2nd Medical Faculty of Charles University, Department of Endocrinology and Diabetology.
- Download data from an existing pump / sensor for the last 3 months to Carelink or Diasend
- Creating a DexCom Clarity and Diasend / Tidepool account (certified patient data store)
- Training of the patient in the use of the DANA RS Diabcare pump and the DexCom G6 CGM
- Training of Samsung S10e mobile phone with active version of Pancreas4ALL application connected to Dana RS Diabcare and Dexcom G6 IP - mode open loop
- Application of DANA RS Diabcare insulin pump and CGM Dexcom G6 to the patients
- Optimization of basal dose and bolus calculator settings using Pancreas4ALL advisor (calculation based on patient's age, weight and CDD)
- Education about the necessary inputs (data entered by the patient) into the Pancreas4ALL application.
- Activation of the Pancreas4ALL application - open loop. Preprandial bolus calculated by the patient using a bolus calculator, part of the Pancreas4ALL application.
- Completion of the Quality of Life (QoL) Questionnaire PedsQl
Defined Pancreas4ALL settings for all subjects.
- Target glycemia 5.5 mmol / mol
- Active insulin time 6 hours
- Setting automatic functions: In case of hypoglycemia (glycemia below 3.9 mmol / l), a temporary blood glucose target of 8 mmol / l is automatically set for 30 minutes after the hypoglycemia has occurred.
Another activities:
- In case of physical activity, it is recommended that the patient temporarily increase the target glycemia to 8 mmol / l, switch to a temporary profile of 70-80% depending on the intensity of physical activity (automatic recalculation of basal dose, insulin sensitivity, insulin carbohydrate ratio to 70-80%)
- In case of illness accompanied by an increase in glycaemia, the patient is recommended to switch to a temporary profile of 120-150% (automatic recalculation of the basal dose, insulin sensitivity, insulin carbohydrate ratio at the set 120-150%)
Day 2:
- Initiation - activation of the "closed loop" Pancreas4All in the hybrid closed loop mode (2.7.1)
- The patient will enter the number of carbohydrates eaten into the application, using the bolus calculator to calculate the preprandial bolus.
- Meal blood glucose will be corrected using the Pancreas4All automated system.
- In case of glycemia above 13 mmol / l 30 min after a meal, the correction bolus will be calculated using a bolus calculator. Hyperglycemia management see appendix.
- In case of hypoglycaemia (glycaemia <3.9 mmol /), the subject will be given dextrose in the form of tablets or a sweet drink (the amount of dextrose will be calculated according to the patient's weight, current level and glycemic trend) See Appendix.
Day 4:
- Randomization to group A and group B
- Randomization will be performed using an IT application according to age, gender, weight and input glycated hemoglobin.
- Randomization:
- Group A: Activation of Pancreas4ALL in closed loop mode in "meal announcement" (version 2.7.2). The patient will only enter a notification in the application that he is going to eat.
- Group B: Activation of the Pancreas4ALL application in mode full closed loop mode (version 2.7.3). The subject will not enter any notification or notification into the application that it is going to eat.
- Other settings + glycemic control remain as in the previous phase.
Day 7 - Cross-over - change of settings for groups A and B:
- The basic settings remain unchanged
- Change the setting mode in groups A and B
- Blood glucose control see above.
Day 10 - Visit 2 - End of study:
- Download data from pump to DexCom clarity and Diasend / Tidepool, check data storage from IP and sensor
- Evaluation of glycemic control for the last week
- Completion of the PedsQl Quality of Life (QoL) Questionnaire + System Satisfaction Questionnaire.
- Termination of the study - return to the standard treatment modality of the patients
- Conditions
- Type 1 Diabetes
- Being tested
- Pancreas4ALL - meal announcement or full closed loop
- Keywords
- closed loop system
- 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.
Pancreas4ALL - meal announcement or full closed loopDevice
Patient using AID Pancreas4ALL in mode meal announcment or full closed loop.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Pancreas4ALL - meal announcement or full closed loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of the prototype device Pancreas4ALL
Percentage of time of automatic control of glucose by Pancreas4ALL would be > 90%
Measured: 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
Measured: ten days
Secondary outcomes (2)
GCM parametrs of glycemic control
Calculation of Time in range (3.9 - 10 mmol / l) which would be > 75% throughout the study Translation results "The secondary goal is excellent glycemic control in all tested versions of the Pancreas4ALL closed loop application (version 2.7.1, version 2.7.2, version 2.7.3), defined as the time spent in Time in range (3.9 - 10 mmol / l) > 70% throughout the study. "
Measured: ten days
Quality of life of patient living on closed loop system Pancreas4ALL
PedsQL Diabetes Module 3.2 - questionnaire
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start19 Feb 2021
- Primary completion30 Apr 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Pilot prospective controlled monocentric open-label, randomized study evaluating the feasibility and safety of Pancreas4All automated "closed loop" system.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lenka Petruzelkova
- Sponsor type
- University, hospital or other
- Collaborators
- CLOSED LOOP Systems s.r.o.
- Responsible party
- Sponsor-investigator, Lenka Petruzelkova, University Hospital, Motol
- Investigators
- Lenka Petruzelkova, MD, PhD, Principal investigator, Department of Paediatrics, Motol University Hospital, Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835350
- Sponsor's protocol ID
- 01-CIP-27-11-20
- Acronym
- ASAP
- Status last verified
- Apr 2021
- First submitted
- 23 Mar 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: basic characteristic of participants and all results
Publications
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.
PubMed 36826996
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Pancreas4ALL Closed-loop Automated Glycemic Control System in Patients With Type 1 Diabetes Mellitus: Pancreas4ALL Project - Good News Study - Phase I
- ClinicalTrials.gov ID
- NCT04835350
- Acronym / sponsor ID
- ASAP / 01-CIP-27-11-20
- Conditions
- Type 1 Diabetes
- Keywords
- closed loop system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Lenka PetruzelkovaUniversity, hospital or other
- Collaborators
- CLOSED LOOP Systems s.r.o.
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 8 Apr 2021 (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.
Pilot prospective controlled monocentric open-label, randomized study evaluating the feasibility and safety of the Pancreas4All automated "closed loop" glycemic control system.
Detailed description
- Screening - day 0
- 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 (2.7.1) Day 4 - Randomization of patients to Group A and to Group B Group A - Activation of Pancreas4ALL closed loop in closed loop mode - "food announcement" (2.7.2) Group B - Activation of Pancreas4ALL closed loop in mode - full closed loop mode (2.7.3) Day 7 - Crossover - Group exchange Day 10 - Return to the initial treatment modality.
- Termination of the study
Detailed description of the clinical trial - study control plan:
Outpatient check:
- Signing of informed consents to the study and GDPR consent to the processing of personal data by the legal representative and the entity that will be included in the study
- Urine pregnancy test for women and girls after menarche
- Blood collection for the determination of HbA1c, TSH and creatinine
- Evaluation of entry criteria (inclusion criteria); if all criteria are met, the subject will be included in the study.
Day 1:
- Hospitalization in the inpatient part of the University Hospital and the 2nd Medical Faculty of Charles University, Department of Endocrinology and Diabetology.
- Download data from an existing pump / sensor for the last 3 months to Carelink or Diasend
- Creating a DexCom Clarity and Diasend / Tidepool account (certified patient data store)
- Training of the patient in the use of the DANA RS Diabcare pump and the DexCom G6 CGM
- Training of Samsung S10e mobile phone with active version of Pancreas4ALL application connected to Dana RS Diabcare and Dexcom G6 IP - mode open loop
- Application of DANA RS Diabcare insulin pump and CGM Dexcom G6 to the patients
- Optimization of basal dose and bolus calculator settings using Pancreas4ALL advisor (calculation based on patient's age, weight and CDD)
- Education about the necessary inputs (data entered by the patient) into the Pancreas4ALL application.
- Activation of the Pancreas4ALL application - open loop. Preprandial bolus calculated by the patient using a bolus calculator, part of the Pancreas4ALL application.
- Completion of the Quality of Life (QoL) Questionnaire PedsQl
Defined Pancreas4ALL settings for all subjects.
- Target glycemia 5.5 mmol / mol
- Active insulin time 6 hours
- Setting automatic functions: In case of hypoglycemia (glycemia below 3.9 mmol / l), a temporary blood glucose target of 8 mmol / l is automatically set for 30 minutes after the hypoglycemia has occurred.
Another activities:
- In case of physical activity, it is recommended that the patient temporarily increase the target glycemia to 8 mmol / l, switch to a temporary profile of 70-80% depending on the intensity of physical activity (automatic recalculation of basal dose, insulin sensitivity, insulin carbohydrate ratio to 70-80%)
- In case of illness accompanied by an increase in glycaemia, the patient is recommended to switch to a temporary profile of 120-150% (automatic recalculation of the basal dose, insulin sensitivity, insulin carbohydrate ratio at the set 120-150%)
Day 2:
- Initiation - activation of the "closed loop" Pancreas4All in the hybrid closed loop mode (2.7.1)
- The patient will enter the number of carbohydrates eaten into the application, using the bolus calculator to calculate the preprandial bolus.
- Meal blood glucose will be corrected using the Pancreas4All automated system.
- In case of glycemia above 13 mmol / l 30 min after a meal, the correction bolus will be calculated using a bolus calculator. Hyperglycemia management see appendix.
- In case of hypoglycaemia (glycaemia <3.9 mmol /), the subject will be given dextrose in the form of tablets or a sweet drink (the amount of dextrose will be calculated according to the patient's weight, current level and glycemic trend) See Appendix.
Day 4:
- Randomization to group A and group B
- Randomization will be performed using an IT application according to age, gender, weight and input glycated hemoglobin.
- Randomization:
- Group A: Activation of Pancreas4ALL in closed loop mode in "meal announcement" (version 2.7.2). The patient will only enter a notification in the application that he is going to eat.
- Group B: Activation of the Pancreas4ALL application in mode full closed loop mode (version 2.7.3). The subject will not enter any notification or notification into the application that it is going to eat.
- Other settings + glycemic control remain as in the previous phase.
Day 7 - Cross-over - change of settings for groups A and B:
- The basic settings remain unchanged
- Change the setting mode in groups A and B
- Blood glucose control see above.
Day 10 - Visit 2 - End of study:
- Download data from pump to DexCom clarity and Diasend / Tidepool, check data storage from IP and sensor
- Evaluation of glycemic control for the last week
- Completion of the PedsQl Quality of Life (QoL) Questionnaire + System Satisfaction Questionnaire.
- Termination of the study - return to the standard treatment modality of the patients
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Pilot prospective controlled monocentric open-label, randomized study evaluating the feasibility and safety of Pancreas4All automated "closed loop" system.
| Arm | Type | Receives |
|---|---|---|
| Hybrid closed loop group | No intervention | –Patients using AID system Pancreas4ALL in mode hybrid closed loop. |
| Closed loop meal announcment | Experimental | Device: Pancreas4ALL - meal announcement or full closed loopPatients using AID system Pancreas4ALL in mode meal announcment. They only announce what amout of carbs going to eat. They calculate no bolus |
| Full closed loop | Experimental | Device: Pancreas4ALL - meal announcement or full closed loopPatients using AID system Pancreas4ALL in mode full closed loop. They eating with no permission and they do not calculate and sending bolus anymore. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Pancreas4ALL - meal announcement or full closed loopPatient using AID Pancreas4ALL in mode meal announcment or full closed loop. | Device | Closed loop meal announcment, Full closed loop |
Primary outcome
The feasibility of the prototype device Pancreas4ALL
Time frame: ten days
Percentage of time of automatic control of glucose by Pancreas4ALL would be > 90%
The safety of the prototype device Pancreas4ALL
Time frame: ten days
Percentage of time spent in hypoglycemia 2.degrees (<3 mmol / L) would be < 1% during sutomatic glucose control by Pancreas4ALL
2 secondary outcomes
GCM parametrs of glycemic control
Time frame: ten days
Quality of life of patient living on closed loop system Pancreas4ALL
Time frame: seven days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Derived from this study: PubMed 36826996Petruzelkova 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.
- Individual participant dataSharing planned: Yes. basic characteristic of participants and all results
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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.
Lenka Petruzelkova, MD, PhD principal investigator
Department of Paediatrics, Motol University Hospital, Charles University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreas4ALL - meal announcement or full closed loop in people with Type 1 Diabetes, run by Lenka Petruzelkova at 1 site in Czechia.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lenka Petruzelkova, MD, PhD (+420775983866, lenkapetruzelkova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of the prototype device Pancreas4ALL (time frame: ten days). 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?
On the ClinicalTrials.gov record for NCT04835350, which also lists 1 linked publication.
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 8 Apr 2021.