The Bio-Inspired Artificial Pancreas for the Home

NCT03740698 | Terminated Results

• 1 other identifier: 17HH3730
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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. 1.A glucose sensor that measures glucose every 5 minutes
2. 2.A control algorithm that calculates the required insulin dose
3. 3.An insulin pump that delivers the insulin calculated

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• % 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

Study Arms (3)

SAP, open-loop

NO INTERVENTION

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

BiAP, fixed bolus calculator

EXPERIMENTAL

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

Device: BiAP

BiAP, ABC4D

EXPERIMENTAL

Bio-inspired Artificial Pancreas (closed-loop system) with the Advanced Bolus Calculator for Diabetes (ABC4D)

Device: BiAP; Device: ABC4D

Interventions

BiAP 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; BiAP, fixed bolus calculator

ABC4D 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.

BiAP, ABC4D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Clinical Research Facility

London, United Kingdom

Location

Related 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.

  PMID: 23851519 BACKGROUND

• 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.

  PMID: 20144397 BACKGROUND

• 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.

  PMID: 19444330 BACKGROUND

• 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.

  PMID: 24956470 BACKGROUND

• 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.

  PMID: 22768892 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Prof Nick Oliver
• Organization: Imperial College London

nick.oliver@imperial.ac.uk

+44 (0)20 7594 1796

Study Officials

• Nick Oliver

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 3-way crossover open-label randomized controlled trial. Description of the three interventions for comparison are as follows: 1. Sensor augmented pump (combination of insulin pump and continuous glucose monitoring) (open-loop system) 2. Bio-inspired Artificial Pancreas (closed-loop system) with a fixed bolus calculator 3. Bio-inspired Artificial Pancreas (closed-loop system) with the Advanced Bolus Calculator for Diabetes (ABC4D) The intervention in each arm will be assessed over 6 weeks with a minimum 2-week break in between each intervention. During the break participants will revert back to usual pump therapy.

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 14, 2018
• Study Start: February 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: February 5, 2024
• Results First Posted: February 5, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)