Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346366
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-02-22
Brief Title:
Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy PANORAMA Randomized Controlled Crossover Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
PANORAMA
Brief Summary:
In recent years total pancreatectomy is increasingly performed in selected patients due to the increasing use of preoperative chemotherapy making more patients operable After total pancreatectomy all patients develop insulin dependent diabetes mellitus IDDM Glucose control in these patients is challenging due to the complete absence of both pancreatic insulin and glucagon secretion and most patients report decreased quality of life due to fear of hypoglycemic events and the need for continuous glucose monitoring
The CE marked bihormonal artificial pancreas BIHAP provides continuous fully automatic glucose monitoring and administration of insulin and glucagon using a self-learning algorithm In a recent pilot study APPEL5 NL8871 the BIHAP was being compared to current diabetes treatment in 10 patients after total pancreatectomy This trial demonstrated that treatment with BIHAP was safe and improved time spent in euglycemia significantly during one week treatment 7830 IQR 7105-8261 vs 5738 IQR 5238-8135 p003
Now larger randomized studies with a longer treatment period are necessary to confirm safety and efficacy of BIHAP for the treatment of diabetes in patients after total pancreatectomy with sufficient attention for long-term glycemic control HbA1c and patient-reported outcomes
The PANORAMA trial will evaluate the efficacy of a 3-month treatment with BIHAP in 40 patients after total pancreatectomy as compared to a 3-month treatment period with current diabetes care in a randomized cross-over trial Patients will be randomized to start with the BIHAP after a training period or current diabetes care ie insulin pen or pump Hereafter all patients will cross over
The CE marked bihormonal artificial pancreas BIHAP provides continuous fully automatic glucose monitoring and administration of insulin and glucagon using a self-learning algorithm In a recent pilot study APPEL5 NL8871 the BIHAP was being compared to current diabetes treatment in 10 patients after total pancreatectomy This trial demonstrated that treatment with BIHAP was safe and improved time spent in euglycemia significantly during one week treatment 7830 IQR 7105-8261 vs 5738 IQR 5238-8135 p003
Now larger randomized studies with a longer treatment period are necessary to confirm safety and efficacy of BIHAP for the treatment of diabetes in patients after total pancreatectomy with sufficient attention for long-term glycemic control HbA1c and patient-reported outcomes
The PANORAMA trial will evaluate the efficacy of a 3-month treatment with BIHAP in 40 patients after total pancreatectomy as compared to a 3-month treatment period with current diabetes care in a randomized cross-over trial Patients will be randomized to start with the BIHAP after a training period or current diabetes care ie insulin pen or pump Hereafter all patients will cross over
Detailed Description:
Rationale
Insulin dependent diabetes after total pancreatectomy TP is difficult to manage due to the complete absence of alfa and beta cells In a recent pilot study in 10 patients after total pancreatectomy treatment with a bihormonal closed loop system was safe and resulted in better glucose control compared to current open loop therapy
Objective
To assess the efficacy of a 3-month treatment with a bihormonal artificial pancreas BIHAP in patients after total pancreatectomy compared to current diabetes care
Secondary objectives are to assess the safety of BIHAP treatment quality of life during BIHAP treatment and additional efficacy parameters
Study design
PANORAMA is a randomized cross-over trial performed in an outpatient setting comparing closed loop diabetes treatment with BIHAP to open loop with current diabetes care ie insulin pump or pen therapy in 40 adults after TP Patients will be recruited from Dutch Pancreatic Cancer Group hospitals and randomized to a 3-month treatment period with the BIHAP preceded by a 5-day training period or a 3-month treatment with their current diabetes care Hereafter all 40 patients will cross over Study population This trial will comprise in total 40 adult patients with insulin dependent diabetes at least three months after total pancreatectomy
Intervention The intervention is 3 months closed loop control of blood glucose with the BIHAP Patients complete a 5-day training period before the intervention period will start The BIHAP contains a self-learning algorithm which automatically maintains the glucose levels within target limits via subcutaneous administration of insulin Humalog and glucagon The control arm open loop consists of standard treatment for diabetes with continuous subcutaneous insulin infusion or insulin injections for 3 months After a wash-out period of 3 months all patients will crossover to the other study arm
Main study parametersendpoints
The primary endpoint will be time in spent in the normal glucose range 39 mmoll - 100 mmoll
Nature and extent of the burden and risks associated with participation benefit and group relatedness
Patients will have to wear the prototype with two subcutaneous sensors and infusion sets continuously There are no major risks associated with this study The most prominent risk is failure of the BIHAP to regulate the plasma glucose concentration properly which can result in hypo- or hyperglycemia This may be caused by failure of the algorithm technical failure or due to incorrect glucose measurements However with multiple risk control measures the risk for the patients is minimized The system comprises a controller a separate safety processor as well as multiple alerts that are built in the system
The potential benefits for each patient include a significantly better glycemic control as well as improved quality of life because the BIHAP system completely takes over the glucose regulation thereby minimizing the burden of life with diabetes
Insulin dependent diabetes after total pancreatectomy TP is difficult to manage due to the complete absence of alfa and beta cells In a recent pilot study in 10 patients after total pancreatectomy treatment with a bihormonal closed loop system was safe and resulted in better glucose control compared to current open loop therapy
Objective
To assess the efficacy of a 3-month treatment with a bihormonal artificial pancreas BIHAP in patients after total pancreatectomy compared to current diabetes care
Secondary objectives are to assess the safety of BIHAP treatment quality of life during BIHAP treatment and additional efficacy parameters
Study design
PANORAMA is a randomized cross-over trial performed in an outpatient setting comparing closed loop diabetes treatment with BIHAP to open loop with current diabetes care ie insulin pump or pen therapy in 40 adults after TP Patients will be recruited from Dutch Pancreatic Cancer Group hospitals and randomized to a 3-month treatment period with the BIHAP preceded by a 5-day training period or a 3-month treatment with their current diabetes care Hereafter all 40 patients will cross over Study population This trial will comprise in total 40 adult patients with insulin dependent diabetes at least three months after total pancreatectomy
Intervention The intervention is 3 months closed loop control of blood glucose with the BIHAP Patients complete a 5-day training period before the intervention period will start The BIHAP contains a self-learning algorithm which automatically maintains the glucose levels within target limits via subcutaneous administration of insulin Humalog and glucagon The control arm open loop consists of standard treatment for diabetes with continuous subcutaneous insulin infusion or insulin injections for 3 months After a wash-out period of 3 months all patients will crossover to the other study arm
Main study parametersendpoints
The primary endpoint will be time in spent in the normal glucose range 39 mmoll - 100 mmoll
Nature and extent of the burden and risks associated with participation benefit and group relatedness
Patients will have to wear the prototype with two subcutaneous sensors and infusion sets continuously There are no major risks associated with this study The most prominent risk is failure of the BIHAP to regulate the plasma glucose concentration properly which can result in hypo- or hyperglycemia This may be caused by failure of the algorithm technical failure or due to incorrect glucose measurements However with multiple risk control measures the risk for the patients is minimized The system comprises a controller a separate safety processor as well as multiple alerts that are built in the system
The potential benefits for each patient include a significantly better glycemic control as well as improved quality of life because the BIHAP system completely takes over the glucose regulation thereby minimizing the burden of life with diabetes
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None