Ignite Creation Date:
2024-05-06 @ 7:54 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02620878
Status:
COMPLETED
Last Update Posted:
2019-07-12
First Post:
2015-11-18
Brief Title:
Artificial Pancreas in Pediatric Patients PEDarPAN
Sponsor:
University of Padova
Organization:
University of Padova
Study Overview
Official Title:
Use of Artificial Pancreas in Pediatric Patients Feasibility Safety and Efficacy Study of an Automatic Control of Blood Glucose 2424 at a Diabetes Camp
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
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:
PEDarPAN
Brief Summary:
The purpose of this study is to determine safety feasibility and efficacy with respect to sensor- augmented pump therapy of an Artificial Pancreas AP prototype in day and night closed-loop control in children and adolescents with type 1 diabetes
Detailed Description:
The AP prototype is based on a Modular Model Predictive Control algorithm MMPC implemented on the Diabetes Assistant DiAs wearable platform
The study will be divided in two parts the first part will serve as a 3 days pilot study and will be conducted in a hotelresidence near the hospital
The investigators will recruit 68 children 5-12 years andor 68 adolescents 12-18 years with type 1 diabetes who have experience with insulin pump DiAs will be used 72 continuous hours of day and night
If part 1 will be successfully after about 2-3 months the study will move to the second part the main part that will consist in cross-over randomized study that will be conducted in a camp setting The participants will be randomly assigned to the treatment arm Artificial Pancreas or to the control arm sensor-augmented insulin pump Then the same patient will be assigned to the other arm Each treatment will be applied 3 consecutive days During the first period days 1-3 patients will do the same activites and will have the same diet as in the second period day s 5-7
The investigators will recruit 3040 children 5-12 years andor 3040 adolescents 12-18 years affected by type 1 diabetes who have experience with insulin pump therapy
The study has the permission of the Ethics Committee reference and the permission for clinical investigation with devices not CE marked by the Health Ministry
The study will be divided in two parts the first part will serve as a 3 days pilot study and will be conducted in a hotelresidence near the hospital
The investigators will recruit 68 children 5-12 years andor 68 adolescents 12-18 years with type 1 diabetes who have experience with insulin pump DiAs will be used 72 continuous hours of day and night
If part 1 will be successfully after about 2-3 months the study will move to the second part the main part that will consist in cross-over randomized study that will be conducted in a camp setting The participants will be randomly assigned to the treatment arm Artificial Pancreas or to the control arm sensor-augmented insulin pump Then the same patient will be assigned to the other arm Each treatment will be applied 3 consecutive days During the first period days 1-3 patients will do the same activites and will have the same diet as in the second period day s 5-7
The investigators will recruit 3040 children 5-12 years andor 3040 adolescents 12-18 years affected by type 1 diabetes who have experience with insulin pump therapy
The study has the permission of the Ethics Committee reference and the permission for clinical investigation with devices not CE marked by the Health Ministry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None