Advanced Bolus Calculator for Type 1 Diabetes (ABC4D) (ABC4D)

March 15, 2024 updated by: Imperial College London

Clinical Assessment of an Advanced Bolus Calculator for Type 1 Diabetes (ABC4D)

This study aims to assess the safety and efficacy of a novel advanced bolus calculator in subjects with Type 1 diabetes. Insulin bolus calculators have been developed to aid insulin dose adjustment and existing standard insulin bolus calculator consist of a simple algorithm that requires five subject-specific parameters as input to generate a recommended bolus insulin dose:

  • current blood glucose (mmol/L)
  • target blood glucose (mmol/L)
  • insulin-to-carbohydrate ratio (grams of carbohydrate per 1 unit of insulin)
  • total grams of carbohydrate in meals
  • insulin sensitivity factor (reduction in glucose per 1 unit of insulin)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Diabetes Technology team at Imperial College have developed a novel advanced bolus calculator. The complete integrated system consists of a commercially available smartphone that holds the novel advanced algorithm. The system requires regular updates of cases derived from retrospective blinded continuous glucose monitoring data and for this a commercially available glucose sensor will be used. Each new case includes information about the problem (e.g. capillary blood glucose, meal information and physical exercise), solution (recommended insulin dose) and outcome (blood glucose following a meal). The novel decision support algorithm is based on case-based reasoning (CBR). CBR is an artificial intelligence technique that tries to solve newly encountered problems by applying the solutions learned from solved problems encountered in the past.

The end-product is therefore a subject specific insulin bolus calculator that continues to improve with time. The project utilises commercially available glucose sensors and smartphones (iPhone), integrated with a novel algorithm for insulin bolus calculation. The aim of the ABC4D is to minimise high and low glucose excursions which are associated with the complications of diabetes including blindness, kidney failure, nerve damage and cardiovascular disease.

An interim analysis was conducted in Phase 4 after 25 participants completed the study (in line with the protocol) and it was agreed to stop the study at this stage. A further protocol amendment was approved by REC/MHRA to commence ABC4D phase 5 (different CT.gov number: NCT03963219).

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W2 1PG
        • Imperial College London, Imperial College Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults ≥18 years of age
  • Diagnosis of T1DM for > 1 year
  • On MDI using a basal-bolus insulin regime
  • Structured education in previous 3 years
  • HbA1c ≤ 86mmol/mol
  • No severe hypoglycaemia (defined as needing 3rd party assistance) in previous year

Exclusion Criteria:

  • Recurrent severe hypoglycaemia
  • Pregnant or planning pregnancy
  • Breastfeeding
  • Enrolled in other clinical trials
  • Have active malignancy or under investigation for malignancy
  • Addison's Disease
  • Gastroparesis
  • Autonomic neuropathy
  • Concomitant use of GLP-1 analogues and gliptins
  • Visual impairment
  • Reduced manual dexterity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 4: Intervention (ABC4D)
Advanced Bolus Calculator for Type Diabetes (ABC4D)
Device: ABC4D
Advanced Bolus Calculator for Type 1 Diabetes (ABC4D) to calculate pre-meal insulin boluses
Active Comparator: Phase 4 Control: Standard bolus calculator
Standard bolus calculator
Device: Standard bolus calculator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Baseline to 6 months
Change in HbA1c
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Time in Target Range
Time Frame: Baseline and 6 months
Difference between baseline and 6-month endpoint.
Baseline and 6 months
Percentage Time in Hypoglycaemia
Time Frame: Baseline and 6 months
Difference from baseline to 6-month endpoint.
Baseline and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
PAID score questionnaire
Time Frame: 6 months (Phase 3 only)
Quality of life measure
6 months (Phase 3 only)
Acceptability questionnaire (non-validated)
Time Frame: For Phase 1 the time frame is 8 hours, for phase 2 it is 6 weeks and for phase 3 participants are followed-up for 6 months
Device acceptability assessment
For Phase 1 the time frame is 8 hours, for phase 2 it is 6 weeks and for phase 3 participants are followed-up for 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Monika Reddy, Imperial College London
  • Principal Investigator: Desmond Johnston, F.Med.Sci, Imperial College London
  • Principal Investigator: Nick Oliver, MRCP, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2013

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

January 31, 2014

First Posted (Estimated)

February 3, 2014

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13SM0091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This was not part of the approved protocol. Any peer-reviewed publications will be shared with the study participants and will be accessible to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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