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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Type 1 Diabetes, Quality of Life, Hypoglycaemia

Intervention / Treatment
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* Device: Webdia Software


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Webdia Software use<br>Use of Webdia Software during 3 months by the patient. Monthly review of blood glucose values by the medical team and automatic adjustment of insulin doses by the team. | Device: Webdia Software<br> <br> |
| No Intervention: Observation<br>No use of the software. No intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Webdia Software use on HbA1C |  | 0, 3, 6 and 9 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Webdia Software use on quality of life | Quality of life assessment by the use of the Diabetes Quality of Life for Youths (DQOLY) questionnaire published by Ingersoll et al. 1991. | 0, 3, 6 and 9 months after inclusion | 
| Effect of Webdia Software use on the incidence of hypoglycaemic events |  | During 2 weeks at the end of the 3-months period of Webdia Software use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HbA1C, Type 1 diabetes, Quality of Life, Hypoglycaemia, Self-management, Telemedicine