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NCT Number: NCT02053051

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)

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College London, Imperial College Healthcare NHS Trust

London, W2 1PG, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABC4D

Device

Advanced Bolus Calculator for Type 1 Diabetes (ABC4D) to calculate pre-meal insulin boluses

Standard bolus calculator

Device

Primary outcomes

  1. HbA1c

    Time frame: Baseline to 6 months

    Change in HbA1c

Secondary outcomes

  1. Percentage Time in Target Range

    Time frame: Baseline and 6 months

    Difference between baseline and 6-month endpoint.

  2. Percentage Time in Hypoglycaemia

    Time frame: Baseline and 6 months

    Difference from baseline to 6-month endpoint.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

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

Acronym: ABC4D

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2014
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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