The Bio-Inspired Artificial Pancreas for the Home

NCT ID: NCT03740698

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-01-31

Brief Summary

The purpose of the study is to evaluate the safety and effectiveness of a closed-loop insulin delivery system (also known as an artificial pancreas) which is made up of three components that communicate with each other:

1. A glucose sensor that measures glucose every 5 minutes

2. A control algorithm that calculates the required insulin dose

3. An insulin pump that delivers the insulin calculated

Detailed Description

In addition to assessing the closed-loop insulin delivery system on its own, the study aims to evaluate the system when combined with a personalised bolus calculator that adapts over time. Standard bolus calculators are widely used in type 1 diabetes self-management to calculate insulin boluses at mealtimes and are incorporated in all insulin pumps and in some glucose meters. A standard bolus calculator uses a generic formula taking into account the target glucose level, current glucose level, carbohydrate content of meal (grams), insulin: carbohydrate ratio (the amount of carbohydrate (grams) covered by 1 unit of insulin), insulin sensitivity factor (the reduction in blood glucose by 1 unit of insulin) and insulin-on-board (IOB, the remaining active insulin from the previous bolus). Some bolus calculators additionally consider parameters such as exercise, but all lack the ability to automatically adapt over time to respond to individual needs.

Finally, the study aims to compare the closed-loop insulin delivery system to standard pump therapy (also known as an open-loop insulin delivery system) in combination with continuous glucose monitoring (referred to as sensor augmented pump).

The Diabetes Technology group at Imperial College have developed a unique closed-loop insulin delivery system known as the Bio-inspired Artificial Pancreas (BiAP) and a personalised bolus calculator known as the Advanced Bolus Calculator for Diabetes (ABC4D).

Overview of the complete closed-loop system (artificial pancreas) used in this study is as follows:

1. A commercially available continuous subcutaneous glucose sensor (Dexcom G5 CGM system).

2. The BiAP control algorithm implemented in a low-power handheld device (developed at Imperial College)

3. An insulin infusion pump (Tandem t:slim) for insulin delivery.

In one part of the study the closed-loop system will be evaluated in combination with:

4. The ABC4D adaptive bolus calculator implemented in a smartphone (as an app)

All the components will be tested together as a combined system.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

SAP, open-loop

Sensor augmented pump (combination of insulin pump and continuous glucose monitoring) (open-loop system)

Group Type: NO_INTERVENTION

No interventions assigned to this group

BiAP, fixed bolus calculator

Bio-inspired Artificial Pancreas (closed-loop system) with a fixed bolus calculator

Group Type: EXPERIMENTAL

BiAP

Intervention Type: DEVICE

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)

Group Type: EXPERIMENTAL

BiAP

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adults over 18 years of age
• Type 1 diabetes confirmed on the basis of clinical features and a random c-peptide <200 pmol/L
• Type 1 diabetes for greater than 1 year
• Continuous subcutaneous insulin infusion for greater than 6 months
• Structured education done (either 1:1 or group education)
• HbA1c <10% (86mmol/mol)
• A negative pregnancy test in female participants of childbearing age

Exclusion Criteria

• More than one episode of severe hypoglycaemia (defined as hypoglycaemia requiring 3rd party assistance) in the preceding year
• Impaired awareness of hypoglycaemia (Gold score >4)
• Pregnant or planning pregnancy
• Breastfeeding
• Enrolled in other clinical trials
• Have active malignancy or under investigation for malignancy
• Severe visual impairment
• Reduced manual dexterity
• Ischaemic heart disease
• Anti-anginal medications
• Regular use of paracetamol
• Unable to participate due to other factors, as assessed by the Chief Investigator

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nick Oliver

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Imperial College Clinical Research Facility

London, , United Kingdom

Countries

United Kingdom

References

Georgiou P, Toumazou C. A silicon pancreatic Beta cell for diabetes. IEEE Trans Biomed Circuits Syst. 2007 Mar;1(1):39-49. doi: 10.1109/TBCAS.2007.893178.

Reference Type: BACKGROUND

PMID: 23851519 (View on PubMed)

Oliver N, Georgiou P, Johnston D, Toumazou C. A benchtop closed-loop system controlled by a bio-inspired silicon implementation of the pancreatic beta cell. J Diabetes Sci Technol. 2009 Nov 1;3(6):1419-24. doi: 10.1177/193229680900300623.

Reference Type: BACKGROUND

PMID: 20144397 (View on PubMed)

Kovatchev BP, Breton M, Man CD, Cobelli C. In silico preclinical trials: a proof of concept in closed-loop control of type 1 diabetes. J Diabetes Sci Technol. 2009 Jan;3(1):44-55. doi: 10.1177/193229680900300106.

Reference Type: BACKGROUND

PMID: 19444330 (View on PubMed)

Herrero P, Pesl P, Reddy M, Oliver N, Georgiou P, Toumazou C. Advanced Insulin Bolus Advisor Based on Run-To-Run Control and Case-Based Reasoning. IEEE J Biomed Health Inform. 2015 May;19(3):1087-96. doi: 10.1109/JBHI.2014.2331896.

Reference Type: BACKGROUND

PMID: 24956470 (View on PubMed)

Herrero P, Georgiou P, Oliver N, Johnston DG, Toumazou C. A bio-inspired glucose controller based on pancreatic beta-cell physiology. J Diabetes Sci Technol. 2012 May 1;6(3):606-16. doi: 10.1177/193229681200600316.

Reference Type: BACKGROUND

PMID: 22768892 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17HH3730

Identifier Type: -

Identifier Source: org_study_id