Advanced Bolus Calculator for Type 1 Diabetes (ABC4D)

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: Standard bolus calculator; Device: ABC4D

• Registration Number: NCT02053051
• Lead Sponsor: Imperial College London

Brief Summary

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)

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-11-12
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-31
• Study First Posted: 2014-02-03
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-31
• Results First Submitted: 2022-10-12
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Results First Posted: 2024-08-16
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 4 Control: Standard bolus calculator	Standard bolus calculator	Standard bolus calculator
Phase 4: Intervention (ABC4D)	ABC4D	Advanced Bolus Calculator for Type Diabetes (ABC4D)

Primary Outcome Measures

Name	Time	Method
HbA1c	Baseline to 6 months	Change in HbA1c

Secondary Outcome Measures

Name	Time	Method
Percentage Time in Target Range	Baseline and 6 months	Difference between baseline and 6-month endpoint.
Percentage Time in Hypoglycaemia	Baseline and 6 months	Difference from baseline to 6-month endpoint.

Trial Locations

Locations (1)

Imperial College London, Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom