NCT02053051: ABC4D

Advanced Bolus Calculator for Type 1 Diabetes (ABC4D)

Completed NA Results posted Last updated 16 August 2024

What this trial tests

NA trial testing ABC4D in Type 1 Diabetes in 25 participants. Completed in 31 October 2021.

Timeline

12 November 2013

Primary endpoint
30 October 2021

31 October 2021

Quick facts

Lead sponsor	Imperial College London
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	25
Start date	12 November 2013
Primary completion	30 October 2021
Estimated completion	31 October 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

• ABC4D
• Standard bolus calculator

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

Imperial College London

Who can join

18 and older, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

HbA1c Primary · Baseline to 6 months

Change in HbA1c

Group	Value	95% CI
Intervention (ABC4D) & RT - CGM	-5.0	-11.5 – -4.0
Control: Standard Bolus Calculator & RT-CGM	-3.0	-10.3 – -0.8

Percentage Time in Target Range Secondary · Baseline and 6 months

Difference between baseline and 6-month endpoint.

Group	Value	95% CI
Phase 4 Intervention: ABC4D	0.9	-1.4 – 3.6
Phase 4 Control: Standard Bolus Calculator	0.0	-3.6 – 3.8

Percentage Time in Hypoglycaemia Secondary · Baseline and 6 months

Difference from baseline to 6-month endpoint.

Group	Value	95% CI
Phase 4 Intervention: ABC4D	0.5	0.1 – 2.4
Phase 4 Control: Standard Bolus Calculator	-0.2	-1.6 – 4.6

Sponsor's own description

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)

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Artificial Intelligence for Diabetes Management and Decision Support: Literature Review.
   Contreras I, Vehi J. · · 2018 · cited 234× · PMID 29848472 · DOI 10.2196/10775
2. Revolutionizing diabetes care: the role of artificial intelligence in prevention, diagnosis, and patient care.
   Kohli M, Pandey P, Jakhmola V, Saha S, et al · · 2025 · cited 2× · PMID 40454187 · DOI 10.1007/s40200-025-01648-y