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Completed

NCT Number: NCT02107326

Randomized Crossover Study to Test the Impact of Using a Software for Smartphones and Tablets in Treating Type 1 Diabetes

The purpose of this study is to evaluate the impact of a software for smartphones and tablets on type 1 diabetes control and quality of life

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

About this study

The hypothesis underlying this project, is that most calculations necessary for flexible intensive insulin therapy for type 1 diabetes in children can be performed using software installed on a smartphone or tablet that nowadays is carried by most parents and children. Smartphones and tablets can easily communicate with each other and with a desktop computer via the Internet, thereby permitting the exchange of information such as blood glucose values or types of meals among family members and physicians. Finally, software collecting blood glucose values and merging values obtained on different devices easily permits reviewing these values by the patient and sending them to the physician's office, thereby avoiding consultations during which no blood glucose values are brought by the patient.

We hypothesize that the Webdia software, that will be tested in this randomized crossover study, will increase treatment compliance and therefore will improve diabetes self-management. We believe, the software will facilitate the adaptation of insulin schemes by physicians and therefore will lead to improved HbA1C values. We also think that this software will improve the patient's quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 10 - 18 years
  • Type 1 diabetes mellitus with positive auto-antibodies against Islet Antigen (IA) 2, insulin, islets, Glutamic Acid Decarboxylase (GAD) 65 or Zink
  • Disease duration equal or more than 6 months
  • Treatment by subcutaneous insulin: by multiple daily injections of pump therapy

Exclusion criteria

  • Previous use of Webdia Software
  • Absence of hardware necessary to install the Webdia Software

Treatment and study plan

Webdia Software

Device

Primary outcomes

  1. Effect of Webdia Software use on HbA1C

    Time frame: 0, 3, 6 and 9 months after inclusion

Secondary outcomes

  1. Effect of Webdia Software use on quality of life

    Time frame: 0, 3, 6 and 9 months after inclusion

    Quality of life assessment by the use of the Diabetes Quality of Life for Youths (DQOLY) questionnaire published by Ingersoll et al. 1991.

  2. Effect of Webdia Software use on the incidence of hypoglycaemic events

    Time frame: During 2 weeks at the end of the 3-months period of Webdia Software use

Sponsors and collaborators

Lead sponsor

Philippe Klee

Other

Registry information

Official study title

Webdia Study: Use of Smartphones to Improve Diabetes Control and Quality of Life in Children With Type 1 Diabetes

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 8, 2014
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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