Type 1 DiabetesABC4DNCT02053051

Advanced Bolus Calculator for Type 1 Diabetes (ABC4D)

A study testing ABC4D and Standard bolus calculator in people with Type 1 Diabetes, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 1 Diabetes
What is being tested?: ABC4D and Standard bolus calculator
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited Kingdom
Study dates: 12 Nov 2013to 31 Oct 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Recurrent severe hypoglycaemia
Pregnant or planning pregnancy
Breastfeeding
Enrolled in other clinical trials
Have active malignancy or under investigation for malignancy
Addison's Disease

Show all 11Show fewer

Gastroparesis
Autonomic neuropathy
Concomitant use of GLP-1 analogues and gliptins
Visual impairment
Reduced manual dexterity

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Imperial College London, Imperial College Healthcare NHS Trust
London, W2 1PG

Other trials in United Kingdom

About this study

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

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)

Read the 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).

Conditions: Type 1 Diabetes
Being tested: ABC4D, Standard bolus calculator
Keywords: Type 1 Diabetes, Advanced Bolus Calculator
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABC4DDevice
Advanced Bolus Calculator for Type 1 Diabetes (ABC4D) to calculate pre-meal insulin boluses
Standard bolus calculatorDevice

Study groups in NCT02053051
Study group	Role	What they receive
Phase 4: Intervention (ABC4D)	Experimental	Advanced Bolus Calculator for Type Diabetes (ABC4D) Receives: Device: ABC4D
Phase 4 Control: Standard bolus calculator	Active comparator	Standard bolus calculator Receives: Device: Standard bolus calculator

What is being measured

The primary outcome is the main question the study is designed to answer.

HbA1c
Change in HbA1c
Measured: Baseline to 6 months

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 201331 Oct 2021

First posted3 Feb 2014 (estimated)
Study start12 Nov 2013
Primary completion30 Oct 2021
Study completion31 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
More trials run by Imperial College LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02053051
Sponsor's protocol ID: 13SM0091
Acronym: ABC4D
Status last verified: Mar 2024
First submitted: 22 Jan 2014
Last updated: 16 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

Reddy M, Pesl P, Xenou M, Toumazou C, Johnston D, Georgiou P, Herrero P, Oliver N. Clinical Safety and Feasibility of the Advanced Bolus Calculator for Type 1 Diabetes Based on Case-Based Reasoning: A 6-Week Nonrandomized Single-Arm Pilot Study. Diabetes Technol Ther. 2016 Aug;18(8):487-93. doi: 10.1089/dia.2015.0413. Epub 2016 May 19.
PubMed 27196358

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Assessment of an Advanced Bolus Calculator for Type 1 Diabetes (ABC4D)
ClinicalTrials.gov ID: NCT02053051
Acronym / sponsor ID: ABC4D / 13SM0091
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes, Advanced Bolus Calculator
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Study start: 12 Nov 2013 (actual)
Primary completion: 30 Oct 2021 (actual)
Study completion: 31 Oct 2021 (actual)
First posted: 3 Feb 2014 (estimated)
Results: Posted 16 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Phase 4: Intervention (ABC4D)	Experimental	Device: ABC4DAdvanced Bolus Calculator for Type Diabetes (ABC4D)
Phase 4 Control: Standard bolus calculator	Active comparator	Device: Standard bolus calculatorStandard bolus calculator

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (11 listed)

Recurrent severe hypoglycaemia
Pregnant or planning pregnancy
Breastfeeding
Enrolled in other clinical trials
Have active malignancy or under investigation for malignancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ABC4DAdvanced Bolus Calculator for Type 1 Diabetes (ABC4D) to calculate pre-meal insulin boluses	Device	Phase 4: Intervention (ABC4D)
Standard bolus calculator	Device	Phase 4 Control: Standard bolus calculator

Primary outcome

HbA1c
Time frame: Baseline to 6 months
Change in HbA1c

2 secondary outcomes

Percentage Time in Target Range
Time frame: Baseline and 6 months
Percentage Time in Hypoglycaemia
Time frame: Baseline and 6 months

Results and safety

Results posted to the registry on 16 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 4 Intervention (ABC4D) & RT - CGM	13	13
Phase 4 Control: Standard Bolus Calculator & RT-CGM	12	12

Primary outcome: HbA1c

Time frame: Baseline to 6 months. Median (Inter-Quartile Range). Unit: mmol/mol

Measure	Intervention (ABC4D) & RT - CGM n = 13	Control: Standard Bolus Calculator & RT-CGM n = 12
Value	-5.0 (-11.5 to -4.0)	-3.0 (-10.3 to -0.8)

Intervention (ABC4D) & RT - CGM vs Control: Standard Bolus Calculator & RT-CGM: p = 0.87, Wilcoxon (Mann-Whitney)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 4 Intervention & Control	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27196358Reddy M, Pesl P, Xenou M, Toumazou C, Johnston D, Georgiou P, Herrero P, Oliver N. Clinical Safety and Feasibility of the Advanced Bolus Calculator for Type 1 Diabetes Based on Case-Based Reasoning: A 6-Week Nonrandomized Single-Arm Pilot Study. Diabetes Technol Ther. 2016 Aug;18(8):487-93. doi: 10.1089/dia.2015.0413. Epub 2016 May 19.
Our research websiteLink provided by the sponsor.
Individual participant dataSharing planned: No. 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.

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Type 1 Diabetes
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Outpatient Pramlintide Study
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Active, not recruitingPhase 2
Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults and Adolescents on Top of Insulin Therapy (FABULINUS)
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Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Desmond Johnston, F.Med.Sci principal investigator

Imperial College London

Nick Oliver, MRCP principal investigator

Imperial College London

Monika Reddy principal investigator

Imperial College London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ABC4D and Standard bolus calculator in people with Type 1 Diabetes, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02053051, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.