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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107326
• Other study ID #: CER13-272
• Status: Completed
• Phase: N/A
• First received: April 3, 2014
• Last updated: October 17, 2017
• Start date: May 2014
• Est. completion date: October 1, 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 1, 2017
• Est. primary completion date: August 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycaemia
• Hypoglycemia
• Quality of Life
• Type 1 Diabetes

Intervention

Device:
• Webdia Software

Locations

Country	Name	City	State
Switzerland	University Hospital of Geneva	Geneva	GE

Sponsors (1)

Lead Sponsor	Collaborator
Philippe Klee

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Webdia Software use on HbA1C		0, 3, 6 and 9 months after inclusion
Secondary	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
Secondary	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

External Links

•   Homepage of the Webdia Software being tested in this study