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The Bio-Inspired Artificial Pancreas for the Home (BiAP@home)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03740698
Recruitment Status : Suspended (Technical issues)
First Posted : November 14, 2018
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: BiAP Device: ABC4D Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Device Feasibility
Official Title: The Bio-Inspired Artificial Pancreas for the Home
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: SAP, open-loop
Sensor augmented pump (combination of insulin pump and continuous glucose monitoring) (open-loop system)
Experimental: BiAP, fixed bolus calculator
Bio-inspired Artificial Pancreas (closed-loop system) with a fixed bolus calculator
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.

Experimental: BiAP, ABC4D
Bio-inspired Artificial Pancreas (closed-loop system) with the Advanced Bolus Calculator for Diabetes (ABC4D)
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.

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.




Primary Outcome Measures :
  1. % time in target range defined as 3.9-10mmol/l [ Time Frame: 6 months ]
    Interstitial blood glucose will be measured every 5 minutes via CGM for a period of six months


Secondary Outcome Measures :
  1. % time spent in euglycaemia (3.9-7.8mmol/l) [ Time Frame: 6 months ]
    Interstitial blood glucose will be measured every 5 minutes via CGM for a period of six months

  2. % time spent in hypoglycaemia (<3.9mmol/l) [ Time Frame: 6 months ]
    Interstitial blood glucose will be measured every 5 minutes via CGM for a period of six months

  3. % time spent in hypoglycaemia (<2.8mmol/l) [ Time Frame: 6 months ]
    Interstitial blood glucose will be measured every 5 minutes via CGM for a period of six months

  4. % time spent in hyperglycaemia (>10mmol/l) [ Time Frame: 6 months ]
    Interstitial blood glucose will be measured every 5 minutes via CGM for a period of six months

  5. % time spent in severe hyperglycaemia (<15mmol/l) [ Time Frame: 6 months ]
    Interstitial blood glucose will be measured every 5 minutes via CGM for a period of six months

  6. Mean sensor glucose [ Time Frame: 6 months ]
    Interstitial blood glucose will be measured every 5 minutes via CGM for a period of six months

  7. Glycaemic variability [ Time Frame: 6 months ]
    Calculation using CGM data

  8. Glycaemic risk as measured by LBGI and HBG [ Time Frame: 6 months ]
    Calculation using CGM data

  9. Closed loop error grid analysis [ Time Frame: 6 months ]
    Calculation using CGM data

  10. Glucose area under the curve [ Time Frame: 6 months ]
    Calculation using CGM data

  11. Insulin requirement in units/kg/hr [ Time Frame: 6 months ]
    Calculation using average insulin delivered per hour and bodyweight

  12. Hypoglycaemia awareness (Gold scores) [ Time Frame: 6 months ]
    Quantitative Gold score questionnaire

  13. Quality of life Questionnaire [ Time Frame: 6 months ]
    Measured via validated questionnaire

  14. Cost-effectiveness [ Time Frame: 6 months ]
    Cost of equipment when compared with standard of care

  15. Device usability [ Time Frame: 6 months ]
    Measured via validated questionnaire

  16. % time in closed loop control [ Time Frame: 6 months ]
    Calculation using BiAP data

  17. Severe hypoglycaemia [ Time Frame: 6 months ]
    Calculation using CGM data

  18. Diabetic ketoacidosis [ Time Frame: 6 months ]
    Incidences of DKA

  19. Sensor MAD% [ Time Frame: 6 months ]
    Calculation using CGM data



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740698


Locations
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United Kingdom
Imperial College Clinical Research Facility
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Nick Oliver Imperial College London

Publications:
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03740698     History of Changes
Other Study ID Numbers: 17HH3730
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Pancrelipase
Pancreatin
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents