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Diabetes Mellitus, Type 1BiAP@homeNCT03740698

The Bio-Inspired Artificial Pancreas for the Home

A study testing BiAP and ABC4D in people with Diabetes Mellitus, Type 1, run by Imperial College London at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
BiAP and ABC4D
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited Kingdom
Study dates
1 Feb 2021to 31 Jan 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Imperial College Clinical Research Facility

    London

Other trials in United Kingdom

About this study

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
Read the 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.

Being tested
BiAP, ABC4D
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiAPDevice

    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.

  • ABC4DDevice

    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.

Study groups in NCT03740698
Study groupRoleWhat they receive
SAP, open-loopNo interventionSensor augmented pump (combination of insulin pump and continuous glucose monitoring) (open-loop system)
BiAP, fixed bolus calculatorExperimentalBio-inspired Artificial Pancreas (closed-loop system) with a fixed bolus calculator
Receives: Device: BiAP
BiAP, ABC4DExperimentalBio-inspired Artificial Pancreas (closed-loop system) with the Advanced Bolus Calculator for Diabetes (ABC4D)
Receives: Device: BiAP; Device: ABC4D

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2018
  2. Study start1 Feb 2021
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

Why it stopped: Technical issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03740698
Sponsor's protocol ID
17HH3730
Acronym
BiAP@home
Status last verified
May 2023
First submitted
7 Nov 2018
Last updated
5 Feb 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23851519

  • 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.

    PubMed 20144397

  • 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.

    PubMed 19444330

  • 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.

    PubMed 24956470

  • 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.

    PubMed 22768892

Questions about this trial

What is this clinical trial studying?

A study testing BiAP and ABC4D in people with Diabetes Mellitus, Type 1, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% Time in Target Range Defined as 3.9-10mmol/l (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03740698, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.

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