NCT03963219 (ABC4D5) is a NA clinical trial of ABC4D in Type 1 Diabetes Mellitus, sponsored by Imperial College London.

Who is sponsoring NCT03963219?

NCT03963219 is sponsored by Imperial College London.

What drugs are being tested in NCT03963219?

Interventions in NCT03963219: ABC4D, Standard Bolus Calculator.

What condition does NCT03963219 study?

NCT03963219 studies Type 1 Diabetes Mellitus.

Is NCT03963219 still recruiting?

NCT03963219 is currently status unknown. Last updated 22 October 2020.

Last reviewed 2020-10-22 · How we verify

NCT03963219: ABC4D5

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Assessment of a Novel Advanced Bolus Calculator for Type 1 Diabetes 5

Status unknown NA Last updated 22 October 2020

What this trial tests

NA trial testing ABC4D in Type 1 Diabetes Mellitus in 37 participants. Status unknown.

Timeline

22 August 2019

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Imperial College London
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	22 August 2019
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

ABC4D
Standard Bolus Calculator

Conditions studied

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

Sponsor

Imperial College London

Who can join

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

Sponsor's own description

The main objective of this study is to assess safety and efficacy of the ABC4D compared to standard therapy (standard bolus calculator) in adults with type 1 diabetes on multiple daily injections (MDI) of insulin in an out-of-clinic setting. Hypothesis: ABC4D is non-inferior to a standard bolus calculator and has an equivalent impact on time in target in adults with type 1 diabetes on MDI

Publications & conference data

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

Safety and Efficacy of an Adaptive Bolus Calculator for Type 1 Diabetes: A Randomized Controlled Crossover Study.
Unsworth R, Armiger R, Jugnee N, Thomas M, et al · · 2023 · cited 8× · PMID 37017468 · DOI 10.1089/dia.2022.0504
Development and Validation of Binary Classifiers to Predict Nocturnal Hypoglycemia in Adults With Type 1 Diabetes.
Afentakis I, Unsworth R, Herrero P, Oliver N, et al · · 2025 · cited 5× · PMID 37434362 · DOI 10.1177/19322968231185796

Verify or expand the search:

Other trials of ABC4D

Trials testing the same drug.

NCT03740698 — The Bio-Inspired Artificial Pancreas for the Home · NA · terminated
NCT02053051 — Advanced Bolus Calculator for Type 1 Diabetes (ABC4D) · NA · completed

Other recruiting trials for Type 1 Diabetes Mellitus

Currently open trials in the same condition.

NCT07142252 — Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus · Phase 2 · recruiting
NCT07296276 — Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM · NA · recruiting
NCT07409701 — Gamification Intervertion in Children With Type 1 Diabetes · NA · recruiting
NCT07356089 — Twiist Postmarket Surveillance Study for Type 1 Diabetes · recruiting
NCT07434154 — Evaluation of Oxidative Stress: Comparison Between Type 1 Diabetes Mellitus and Latent Autoimmune Diabetes in Adults · recruiting

Other Imperial College London trials

Trials by the same sponsor.

NCT06035861 — Endothelial Cell Activation and Total Pulmonary Resistance in PAH · NA · not yet recruiting
NCT07397455 — Development of a Controlled Human Infection Model for Assessment of SARS-CoV-2 Omicron Subvariants · Phase 1 · not yet recruiting
NCT07422532 — A Multi-centre Trial to Assess the Efficacy and Safety of the Omnipod 5 System in People With Type 2 Diabetes Undergoing · NA · not yet recruiting
NCT07389031 — Maralixibat for Intrahepatic Cholestasis of Pregnancy · Phase 2 · not yet recruiting
NCT07358897 — Gender Affirming Hormone Therapy and Immune Function in Trans Individuals - The GIFT Study · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03963219 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Imperial College London
Last refreshed: 22 October 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03963219.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing