MedTrace Logo

Euglyca Application in Children and Adolescents With Type 1 Diabetes Mellitus

NCT03763474 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-12-05

No results posted yet for this study

Summary

80 children and adolescents with Diabetes Mellitus Type 1 were enrolled in the study and were randomly assigned in the intervention group (Euglyca group) or in the control group. Patients in the Euglyca group were asked to use the application in order to calculate the bolus insulin dose. Primary outcomes of the study were the Glycosylated hemoglobin, percentage of normoglycemias and the Diabetes Treatment Satisfaction Questionnaire Score. Patients were evaluated at the baseline, 3, 6 and 12 months after the beginning of the study.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

COMBINATION_PRODUCT

Euglyca application

'Euglyca' is a mobile application developed by two of the authors (CC and DF). The application has a data base of 7000 foods and food products met in greek eating habits as well as the corresponding amount of carbohydrates and lipids for each of them. Subsequently, the amount of carbohydrates and lipids contained in a meal are calculated automatically by the application. By taking into consideration the amount of carbohydrates and lipids to be consumed, the preprandial and target post-prandial glycemia concentrations, the insulin correction factor for the patient, the carbohydrates and lipids factors and the active insulin (in case of CSII), 'Euglyca' calculates the required bolus dose of insulin.

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2018-09-01
Completion
2018-09-01

Countries

  • Greece

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03763474 on ClinicalTrials.gov