NCT03963219

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 22, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

1.9 years

First QC Date

May 8, 2019

Last Update Submit

October 21, 2020

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • % Time blood glucose in target, day time assess by device

    % time blood glucose spent in target (3.9-10mmol/L, 70-180mg/dL) during daytime (0700-2200)

    32 weeks

Study Arms (2)

ABC4D

EXPERIMENTAL

The complete integrated system consists of a smartphone that holds the advanced decision support algorithm. The system requires regular updates of cases derived from continuous glucose monitoring (CGM) data. Each new case includes information about the problem (e.g. capillary blood glucose, meal information and physical exercise), solution (recommended insulin dose) and outcome (post-prandial blood glucose).

Device: ABC4D

Standard Bolus Calculator

ACTIVE COMPARATOR

Standard bolus calculator

Device: Standard Bolus Calculator

Interventions

ABC4DDEVICE

The complete integrated system consists of a smartphone that holds the advanced decision support algorithm. The system requires regular updates of cases derived from continuous glucose monitoring (CGM) data. Each new case includes information about the problem (e.g. capillary blood glucose, meal information and physical exercise), solution (recommended insulin dose) and outcome (post-prandial blood glucose).

ABC4D
Standard Bolus CalculatorDEVICE

Standard bolus calculator

Standard Bolus Calculator

Eligibility Criteria

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

You may qualify if:

  • Adults over 18 years of age
  • HbA1c between 7.0% and 9.0%
  • Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide \<200 pmol/L
  • Type 1 diabetes for greater than 3 years
  • On an intensified multiple dose insulin injection regimen for \> 6 months (MDI)
  • Structured education (either group or 1:1)

You may not qualify if:

  • Pregnant or planning pregnancy
  • Breastfeeding
  • Enrolled in other clinical trials
  • Have active malignancy or under investigation for malignancy
  • Severe visual impairment
  • Reduced manual dexterity
  • Unable to participate due to other factors, as assessed by the Chief Investigator
  • Shift worker
  • Allergy or intolerance to insulin aspart

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Clinical Research Facility

London, W12 0HS, United Kingdom

RECRUITING

Related Publications (1)

  • Unsworth R, Armiger R, Jugnee N, Thomas M, Herrero P, Georgiou P, Oliver N, Reddy M. Safety and Efficacy of an Adaptive Bolus Calculator for Type 1 Diabetes: A Randomized Controlled Crossover Study. Diabetes Technol Ther. 2023 Jun;25(6):414-425. doi: 10.1089/dia.2022.0504.

    PMID: 37017468DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

  • Monika Reddy

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Monika Reddy

CONTACT

020 3312 6037m.reddy@imperial.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomised controlled non-inferiority crossover study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 24, 2019

Study Start

August 22, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)