Euglyca Application in Children and Adolescents With Type 1 Diabetes Mellitus

NCT03763474 | Completed

• 1 other identifier: Euglyca application
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetes

Outcome Measures

Primary Outcomes (6)

• Level of glycosylated hemoglobin in the 2 groups

  Comparison of the level of glycosylated hemoglobin between the 2 groups

  At 3 months after the baseline visit

• Level of glycosylated hemoglobin in the 2 groups

  Comparison of the level of glycosylated hemoglobin between the 2 groups

  At 6 months after the baseline visit

• Level of glycosylated hemoglobin in the 2 groups

  Comparison of the level of glycosylated hemoglobin between the 2 groups

  At 12 months after the baseline visit

• Change from Baseline glycosylated hemoglobin at 3 months in the 2 groups

  Comparison of the differences in the level of glycosylated hemoglobin between the 2 groups

  At 3 months after the baseline visit

• Change from 3 months glycosylated hemoglobin at 6 months in the 2 groups

  Comparison of the differences in the level of glycosylated hemoglobin between the 2 groups

  At 6 months after the baseline visit

• Change from 6 months glycosylated hemoglobin at 12 months in the 2 groups

  Comparison of the differences in the level of glycosylated hemoglobin between the 2 groups

  At 12 months after the baseline visit

Secondary Outcomes (6)

• Percentage of Normoglycemias in the 2 groups

  At 3 months after the baseline visit

• Percentage of Normoglycemias in the 2 groups

  At 6 months after the baseline visit

• Percentage of Normoglycemias in the 2 groups

  At 12 months after the baseline visit

• Diabetes Treatment Satisfaction Questionnaire (DTSQ) score in the 2 groups

  At 3 months after the baseline visit

• Diabetes Treatment Satisfaction Questionnaire (DTSQ) score in the 2 groups

  At 6 months after the baseline visit

Study Arms (2)

Euglyca

EXPERIMENTAL

Patients randomized to the Euglyca group were advised to download the Euglyca application on their smartphones and they were asked to use the application for the calculation of the bolus insulin dose.

Combination Product: Euglyca application

Control

NO INTERVENTION

Interventions

Euglyca application COMBINATION_PRODUCT

'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.

Euglyca

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents with Diabetes Mellitus type 1.
• Treatment with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII)
• Satisfactory knowledge of the concept of carbohydrates and lipids counting

You may not qualify if:

• Use of another medical application for diabetes in the previous 3 months;
• Lack of capacity of reading greek.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Endocrine Unit of 3rd Department of Pediatrics of Aristotle University of Thessaloniki, Hippokration General Hospital

Thessaloniki, 54642, Greece

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors were blinded as for the allocation of the patients in the 2 groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Christos Chatzakis MD, MSc

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 4, 2018
• Study Start: April 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

GR (1)