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

Not Applicable

Completed

• Conditions: Hypoglycaemia; Quality of Life; Type 1 Diabetes
• Interventions: Device: Webdia Software

• Registration Number: NCT02107326
• Lead Sponsor: Philippe Klee

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.

Study Timeline

• Study First Submitted: 2014-04-03
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-08
• Study Start: 2014-05
• Primary Completion: 2017-08-15
• Status Verified: 2017-10
• Study Completion: 2017-10-01
• Last Update Submitted: 2017-10-17
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Webdia Software use	Webdia Software	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.

Primary Outcome Measures

Name	Time	Method
Effect of Webdia Software use on HbA1C	0, 3, 6 and 9 months after inclusion

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital of Geneva; 🇨🇭 Geneva, GE, Switzerland