Hypoglycaemia, Quality of Life, Type 1 Diabetes
Conditions
Keywords
Type 1 diabetes, HbA1C, Quality of Life, Hypoglycaemia, Self-management, Telemedicine
Brief summary
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
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.
Interventions
DEVICEWebdia Software
Sponsors
Philippe Klee
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of Webdia Software use on HbA1C | 0, 3, 6 and 9 months after inclusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Webdia Software use on quality of life | 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. |
| 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 | — |
Countries
Switzerland
Outcome results
None listed