Advanced Bolus Calculator for Type 1 Diabetes (ABC4D)

Type 1 Diabetes Clinical Trial

— ABC4D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053051
• Other study ID #: 13SM0091
• Status: Completed
• Phase: N/A
• Start date: November 12, 2013
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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)

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.

The clinical study has been designed to incrementally assess the device's ability to manage meal time insulin requirements at breakfast and lunch in a controlled supervised clinical environment over 8 hours (phase 1), followed by its use in the home environment over a 6 week period (phase 2) and finally over a 6 month period (phase 3).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Drug:
• Novorapid
Multiple daily injections(MDI) of insulin

Locations

Country	Name	City	State
United Kingdom	Imperial College London, Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PAID score questionnaire	Quality of life measure	6 months (Phase 3 only)
Other	Acceptability questionnaire (non-validated)	Device acceptability assessment	For Phase 1 the time frame is 8 hours, for phase 2 it is 6 weeks and for phase 3 participants are followed-up for 6 months
Primary	HbA1c	Glycaemic control	6 months (phase 3 only)
Primary	Post-prandial hypoglycaemia		For Phase 1 the time frame is 8 hours, for phase 2 it is 6 weeks and for phase 3 participants are followed-up for 6 months
Secondary	Post-meal glucose at 60 and 120 minutes		For Phase 1 the time frame is 8 hours, for phase 2 it is 6 weeks and for phase 3 participants are followed-up for 6 months
Secondary	Post-prandial area under the curve (AUC) at 120 minutes		For Phase 1 the time frame is 8 hours, for phase 2 it is 6 weeks and for phase 3 participants are followed-up for 6 months
Secondary	Hypoglycaemia at 4-hours post-prandially		For Phase 1 the time frame is 8 hours, for phase 2 it is 6 weeks and for phase 3 participants are followed-up for 6 months
Secondary	Glycaemic risk: LBGI and HBGI		For Phase 1 the time frame is 8 hours, for phase 2 it is 6 weeks and for phase 3 participants are followed-up for 6 months
Secondary	Glycaemic variability: MAGE and CONGA-2		For Phase 1 the time frame is 8 hours, for phase 2 it is 6 weeks and for phase 3 participants are followed-up for 6 months
Secondary	Change in weight (kg)		6 months (phase 3 only)
Secondary	Number achieving target HbA1c ( = 53 mmol/mol )		6 months (phase 3 only)

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