Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-27 @ 8:57 AM
Study NCT ID:
NCT04835350
Status:
UNKNOWN
Last Update Posted:
2021-04-08
First Post:
2021-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Safety Study of the Automated Insulin Delivery Closed Loop System Pancreas4ALL
Sponsor:
Lenka Petruzelkova
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASAP
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 (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.
3. Termination of the study
Detailed description of the clinical trial - study control plan:
Outpatient check:
1. 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
2. Urine pregnancy test for women and girls after menarche
3. Blood collection for the determination of HbA1c, TSH and creatinine
4. Evaluation of entry criteria (inclusion criteria); if all criteria are met, the subject will be included in the study.
Day 1:
1. Hospitalization in the inpatient part of the University Hospital and the 2nd Medical Faculty of Charles University, Department of Endocrinology and Diabetology.
2. Download data from an existing pump / sensor for the last 3 months to Carelink or Diasend
3. Creating a DexCom Clarity and Diasend / Tidepool account (certified patient data store)
4. Training of the patient in the use of the DANA RS Diabcare pump and the DexCom G6 CGM
5. Training of Samsung S10e mobile phone with active version of Pancreas4ALL application connected to Dana RS Diabcare and Dexcom G6 IP - mode open loop
6. Application of DANA RS Diabcare insulin pump and CGM Dexcom G6 to the patients
7. Optimization of basal dose and bolus calculator settings using Pancreas4ALL advisor (calculation based on patient's age, weight and CDD)
8. Education about the necessary inputs (data entered by the patient) into the Pancreas4ALL application.
9. Activation of the Pancreas4ALL application - open loop. Preprandial bolus calculated by the patient using a bolus calculator, part of the Pancreas4ALL application.
10. 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:
1\) Initiation - activation of the "closed loop" Pancreas4All in the hybrid closed loop mode (2.7.1)
1. The patient will enter the number of carbohydrates eaten into the application, using the bolus calculator to calculate the preprandial bolus.
2. Meal blood glucose will be corrected using the Pancreas4All automated system.
3. 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.
4. 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:
1. Randomization to group A and group B
2. Randomization will be performed using an IT application according to age, gender, weight and input glycated hemoglobin.
3. Randomization:
1. 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.
2. 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.
4. Other settings + glycemic control remain as in the previous phase.
Day 7 - Cross-over - change of settings for groups A and B:
1. The basic settings remain unchanged
2. Change the setting mode in groups A and B
3. Blood glucose control see above.
Day 10 - Visit 2 - End of study:
1. Download data from pump to DexCom clarity and Diasend / Tidepool, check data storage from IP and sensor
2. Evaluation of glycemic control for the last week
3. Completion of the PedsQl Quality of Life (QoL) Questionnaire + System Satisfaction Questionnaire.
4. Termination of the study - return to the standard treatment modality of the patients
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 (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.
3. Termination of the study
Detailed description of the clinical trial - study control plan:
Outpatient check:
1. 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
2. Urine pregnancy test for women and girls after menarche
3. Blood collection for the determination of HbA1c, TSH and creatinine
4. Evaluation of entry criteria (inclusion criteria); if all criteria are met, the subject will be included in the study.
Day 1:
1. Hospitalization in the inpatient part of the University Hospital and the 2nd Medical Faculty of Charles University, Department of Endocrinology and Diabetology.
2. Download data from an existing pump / sensor for the last 3 months to Carelink or Diasend
3. Creating a DexCom Clarity and Diasend / Tidepool account (certified patient data store)
4. Training of the patient in the use of the DANA RS Diabcare pump and the DexCom G6 CGM
5. Training of Samsung S10e mobile phone with active version of Pancreas4ALL application connected to Dana RS Diabcare and Dexcom G6 IP - mode open loop
6. Application of DANA RS Diabcare insulin pump and CGM Dexcom G6 to the patients
7. Optimization of basal dose and bolus calculator settings using Pancreas4ALL advisor (calculation based on patient's age, weight and CDD)
8. Education about the necessary inputs (data entered by the patient) into the Pancreas4ALL application.
9. Activation of the Pancreas4ALL application - open loop. Preprandial bolus calculated by the patient using a bolus calculator, part of the Pancreas4ALL application.
10. 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:
1\) Initiation - activation of the "closed loop" Pancreas4All in the hybrid closed loop mode (2.7.1)
1. The patient will enter the number of carbohydrates eaten into the application, using the bolus calculator to calculate the preprandial bolus.
2. Meal blood glucose will be corrected using the Pancreas4All automated system.
3. 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.
4. 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:
1. Randomization to group A and group B
2. Randomization will be performed using an IT application according to age, gender, weight and input glycated hemoglobin.
3. Randomization:
1. 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.
2. 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.
4. Other settings + glycemic control remain as in the previous phase.
Day 7 - Cross-over - change of settings for groups A and B:
1. The basic settings remain unchanged
2. Change the setting mode in groups A and B
3. Blood glucose control see above.
Day 10 - Visit 2 - End of study:
1. Download data from pump to DexCom clarity and Diasend / Tidepool, check data storage from IP and sensor
2. Evaluation of glycemic control for the last week
3. Completion of the PedsQl Quality of Life (QoL) Questionnaire + System Satisfaction Questionnaire.
4. Termination of the study - return to the standard treatment modality of the patients
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: