CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 58 enrolled
Drug / intervention
PEPPER systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03849755
NCT03849755N/ACompleted
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Patient Empowerment Through Predictive Personalised Decision Support(PEPPER)-Validation Study.

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta·interventional·Posted Feb 21, 2019·Updated Aug 4, 2020

In Brief

A clinical study evaluating PEPPER system for Diabetes Mellitus, Type 1. Completed, enrolled 58 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesSpain
CollaboratorsImperial College London, Oxford Brookes University, Universitat de Girona, Cellnovo Limited, Romsoft SRL

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 21, 2019
Enrollment StartNov 15, 2018
Primary CompletionNov 9, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 7.4 years ago

Interventions

PEPPER systemdevice

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