The Bio-Inspired Artificial Pancreas for the Home

Diabetes Mellitus, Type 1 Clinical Trial

— BiAP@home  

Official title:

The Bio-Inspired Artificial Pancreas for the Home

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03740698
• Other study ID #: 17HH3730
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: May 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United Kingdom	Imperial College Clinical Research Facility	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Time in Target Range Defined as 3.9-10mmol/l	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.	6 months