Trial Outcomes & Findings for The Bio-Inspired Artificial Pancreas for the Home (NCT NCT03740698)
NCT ID: NCT03740698
Last Updated: 2024-02-05
Results Overview
Interstitial blood glucose will be measured every 5 minutes via CGM for a period of six months (original plan) The study was terminated early. Only two participants entered the allocated study arm and remained in the study for two weeks.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
6 months
Results posted on
2024-02-05
Participant Flow
This study was put on hold after two participants completed two weeks of the intervention (BIAP) due to technical issues. Due to multiple factors this study has not restarted since and a decision has been made to terminate it.
Participant milestones
| Measure |
SAP, Open-loop
Sensor augmented pump (combination of insulin pump and continuous glucose monitoring) (open-loop system)
|
BiAP, Fixed Bolus Calculator
Bio-inspired Artificial Pancreas (closed-loop system) with a fixed bolus calculator
BiAP: The bio-inspired artificial pancreas (BiAP) system uses a control algorithm based on a mathematical model of beta-cell behaviour derived from physiological experiments, carried out by other groups, which have demonstrated how the beta cells in the pancreas produce insulin in people without diabetes. Utilising the data from these experiments it has been possible to implement the behaviour of the beta cell in software and we have used a simulator with 200 virtual patients to demonstrate the safety and efficacy of the algorithm. The data from the simulator have previously been published. The BiAP algorithm is implemented on a miniature silicon microchip within a portable handheld device, which interfaces the components of the artificial pancreas.
|
BiAP, ABC4D
Bio-inspired Artificial Pancreas (closed-loop system) with the Advanced Bolus Calculator for Diabetes (ABC4D)
BiAP: The bio-inspired artificial pancreas (BiAP) system uses a control algorithm based on a mathematical model of beta-cell behaviour derived from physiological experiments, carried out by other groups, which have demonstrated how the beta cells in the pancreas produce insulin in people without diabetes. Utilising the data from these experiments it has been possible to implement the behaviour of the beta cell in software and we have used a simulator with 200 virtual patients to demonstrate the safety and efficacy of the algorithm. The data from the simulator have previously been published. The BiAP algorithm is implemented on a miniature silicon microchip within a portable handheld device, which interfaces the components of the artificial pancreas.
ABC4D: The Advanced Bolus Calculator for Diabetes (ABC4D) is a novel, adaptive decision support algorithm based on case-based reasoning (CBR) providing real-time insulin advice through a smartphone application.
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
SAP, Open-loop
Sensor augmented pump (combination of insulin pump and continuous glucose monitoring) (open-loop system)
|
BiAP, Fixed Bolus Calculator
Bio-inspired Artificial Pancreas (closed-loop system) with a fixed bolus calculator
BiAP: The bio-inspired artificial pancreas (BiAP) system uses a control algorithm based on a mathematical model of beta-cell behaviour derived from physiological experiments, carried out by other groups, which have demonstrated how the beta cells in the pancreas produce insulin in people without diabetes. Utilising the data from these experiments it has been possible to implement the behaviour of the beta cell in software and we have used a simulator with 200 virtual patients to demonstrate the safety and efficacy of the algorithm. The data from the simulator have previously been published. The BiAP algorithm is implemented on a miniature silicon microchip within a portable handheld device, which interfaces the components of the artificial pancreas.
|
BiAP, ABC4D
Bio-inspired Artificial Pancreas (closed-loop system) with the Advanced Bolus Calculator for Diabetes (ABC4D)
BiAP: The bio-inspired artificial pancreas (BiAP) system uses a control algorithm based on a mathematical model of beta-cell behaviour derived from physiological experiments, carried out by other groups, which have demonstrated how the beta cells in the pancreas produce insulin in people without diabetes. Utilising the data from these experiments it has been possible to implement the behaviour of the beta cell in software and we have used a simulator with 200 virtual patients to demonstrate the safety and efficacy of the algorithm. The data from the simulator have previously been published. The BiAP algorithm is implemented on a miniature silicon microchip within a portable handheld device, which interfaces the components of the artificial pancreas.
ABC4D: The Advanced Bolus Calculator for Diabetes (ABC4D) is a novel, adaptive decision support algorithm based on case-based reasoning (CBR) providing real-time insulin advice through a smartphone application.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SAP, Open-loop
Sensor augmented pump (combination of insulin pump and continuous glucose monitoring) (open-loop system)
|
BiAP, Fixed Bolus Calculator
n=1 Participants
Bio-inspired Artificial Pancreas (closed-loop system) with a fixed bolus calculator
BiAP: The bio-inspired artificial pancreas (BiAP) system uses a control algorithm based on a mathematical model of beta-cell behaviour derived from physiological experiments, carried out by other groups, which have demonstrated how the beta cells in the pancreas produce insulin in people without diabetes. Utilising the data from these experiments it has been possible to implement the behaviour of the beta cell in software and we have used a simulator with 200 virtual patients to demonstrate the safety and efficacy of the algorithm. The data from the simulator have previously been published. The BiAP algorithm is implemented on a miniature silicon microchip within a portable handheld device, which interfaces the components of the artificial pancreas.
|
BiAP, ABC4D
n=1 Participants
Bio-inspired Artificial Pancreas (closed-loop system) with the Advanced Bolus Calculator for Diabetes (ABC4D)
BiAP: The bio-inspired artificial pancreas (BiAP) system uses a control algorithm based on a mathematical model of beta-cell behaviour derived from physiological experiments, carried out by other groups, which have demonstrated how the beta cells in the pancreas produce insulin in people without diabetes. Utilising the data from these experiments it has been possible to implement the behaviour of the beta cell in software and we have used a simulator with 200 virtual patients to demonstrate the safety and efficacy of the algorithm. The data from the simulator have previously been published. The BiAP algorithm is implemented on a miniature silicon microchip within a portable handheld device, which interfaces the components of the artificial pancreas.
ABC4D: The Advanced Bolus Calculator for Diabetes (ABC4D) is a novel, adaptive decision support algorithm based on case-based reasoning (CBR) providing real-time insulin advice through a smartphone application.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
0 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 2 participants with type 1 diabetes. Only two weeks worth of data available for preliminary analysis.
Interstitial blood glucose will be measured every 5 minutes via CGM for a period of six months (original plan) The study was terminated early. Only two participants entered the allocated study arm and remained in the study for two weeks.
Outcome measures
| Measure |
SAP, Open-loop
Sensor augmented pump (combination of insulin pump and continuous glucose monitoring) (open-loop system)
|
BiAP, Fixed Bolus Calculator
n=1 Participants
Bio-inspired Artificial Pancreas (closed-loop system) with a fixed bolus calculator
BiAP: The bio-inspired artificial pancreas (BiAP) system uses a control algorithm based on a mathematical model of beta-cell behaviour derived from physiological experiments, carried out by other groups, which have demonstrated how the beta cells in the pancreas produce insulin in people without diabetes. Utilising the data from these experiments it has been possible to implement the behaviour of the beta cell in software and we have used a simulator with 200 virtual patients to demonstrate the safety and efficacy of the algorithm. The data from the simulator have previously been published. The BiAP algorithm is implemented on a miniature silicon microchip within a portable handheld device, which interfaces the components of the artificial pancreas.
|
BiAP, ABC4D
n=1 Participants
Bio-inspired Artificial Pancreas (closed-loop system) with the Advanced Bolus Calculator for Diabetes (ABC4D)
BiAP: The bio-inspired artificial pancreas (BiAP) system uses a control algorithm based on a mathematical model of beta-cell behaviour derived from physiological experiments, carried out by other groups, which have demonstrated how the beta cells in the pancreas produce insulin in people without diabetes. Utilising the data from these experiments it has been possible to implement the behaviour of the beta cell in software and we have used a simulator with 200 virtual patients to demonstrate the safety and efficacy of the algorithm. The data from the simulator have previously been published. The BiAP algorithm is implemented on a miniature silicon microchip within a portable handheld device, which interfaces the components of the artificial pancreas.
ABC4D: The Advanced Bolus Calculator for Diabetes (ABC4D) is a novel, adaptive decision support algorithm based on case-based reasoning (CBR) providing real-time insulin advice through a smartphone application.
|
|---|---|---|---|
|
% Time in Target Range Defined as 3.9-10mmol/l
|
—
|
70 percentage of time spent in target
|
77 percentage of time spent in target
|
Adverse Events
SAP, Open-loop
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BiAP, Fixed Bolus Calculator
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BiAP, ABC4D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place