Patient Empowerment Through Predictive Personalised Decision Support(PEPPER)-Validation Study.

Summary

Patient Empowerment through Predictive PERsonalised Decision Support (PEPPER) is an European Union (EU) funded research project to develop a personalised clinical decision support system for Type 1 Diabetes Mellitus (T1DM) self-management. The tool provides insulin bolus dose advice, tailored to the needs of individuals. The system uses Case-Based Reasoning (CBR), an artificial intelligence methodology that adapts to new situations according to past experience. The PEPPER system also incorporates a safety module that promotes safety by providing glucose alarms, low-glucose insulin suspension, carbohydrate recommendations and fault detection. The principal research objective is to demonstrate safety, feasibility and usability of the PEPPER system compared to a standard bolus calculator.

Conditions

• Diabetes Mellitus, Type 1

Interventions

DEVICE

PEPPER system

The PEPPER system offers insulin dosing advice that is highly adaptive to the insulin needs of individuals by using Case-Base Reasoning (CBR) approach.

Sponsors & Collaborators

• Imperial College London

  collaborator OTHER

• Oxford Brookes University

  collaborator OTHER

• Universitat de Girona

  collaborator OTHER

• Cellnovo Limited

  collaborator OTHER

• Romsoft SRL

  collaborator UNKNOWN

• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

  lead OTHER

Principal Investigators

• José Manuel Fernández Real · Institut d'Investigació Biomèdica de Girona (IDIBGI) Unitat de Diabetis, Endocrinologia i Nutrició de Girona (UDENG) Hospital Universitari de Girona Dr Josep Trueta

• Mercè Fernández-Balsells · Institut d'Investigació Biomèdica de Girona (IDIBGI) Unitat de Diabetis, Endocrinologia i Nutrició de Girona (UDENG) Hospital Universitari de Girona Dr Josep Trueta

• Nick Oliver · Imperial Collage London

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-15

Primary Completion

2019-11-09

Completion

2019-11-09

Countries

• Spain

Study Locations