NCT02053051

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

August 16, 2024

Completed
Last Updated

August 16, 2024

Status Verified

March 1, 2024

Enrollment Period

8 years

First QC Date

January 22, 2014

Results QC Date

October 12, 2022

Last Update Submit

March 15, 2024

Conditions

Type 1 Diabetes

Keywords

Type 1 DiabetesAdvanced Bolus Calculator

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Change in HbA1c

    Baseline to 6 months

Secondary Outcomes (2)

  • Percentage Time in Target Range

    Baseline and 6 months

  • Percentage Time in Hypoglycaemia

    Baseline and 6 months

Study Arms (2)

Phase 4: Intervention (ABC4D)

EXPERIMENTAL

Advanced Bolus Calculator for Type Diabetes (ABC4D)

Device: ABC4D

Phase 4 Control: Standard bolus calculator

ACTIVE COMPARATOR

Standard bolus calculator

Device: Standard bolus calculator

Interventions

ABC4DDEVICE

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

Phase 4: Intervention (ABC4D)
Standard bolus calculatorDEVICE
Phase 4 Control: Standard bolus calculator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London, Imperial College Healthcare NHS Trust

London, W2 1PG, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 27196358DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Prof Nick Oliver
Organization
Imperial College London
nick.oliver@imerial.ac.uk
02075941862

Study Officials

  • Desmond Johnston, F.Med.Sci

    Imperial College London

    PRINCIPAL INVESTIGATOR

  • Nick Oliver, MRCP

    Imperial College London

    PRINCIPAL INVESTIGATOR

  • Monika Reddy

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

February 3, 2014

Study Start

November 12, 2013

Primary Completion

October 30, 2021

Study Completion

October 31, 2021

Last Updated

August 16, 2024

Results First Posted

August 16, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

GB(1)