Clinical trial NCT02107326: Randomized Crossover Study to Test the Impact of Using a Software for Smartphones and Tablets in Treating Type 1 Diabetes
Official title: Webdia Study: Use of Smartphones to Improve Diabetes Control and Quality of Life in Children With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Quality of Life
Hypoglycaemia
Keywords: Type 1 diabetes
HbA1C
Quality of Life
Hypoglycaemia
Self-management
Telemedicine
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 55
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of Webdia Software use on HbA1C
timeFrame: 0, 3, 6 and 9 months after inclusion
Secondary outcomes:
measure: Effect of Webdia Software use on quality of life
timeFrame: 0, 3, 6 and 9 months after inclusion
measure: Effect of Webdia Software use on the incidence of hypoglycaemic events
timeFrame: During 2 weeks at the end of the 3-months period of Webdia Software use
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
state: GE
Study officials:
affiliation: University Hospital, Geneva
name: Philippe Klee, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: