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Clinical Trials/NCT02107326
NCT02107326
Completed
Not Applicable

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

Philippe Klee1 site in 1 country55 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes
Sponsor
Philippe Klee
Enrollment
55
Locations
1
Primary Endpoint
Effect of Webdia Software use on HbA1C
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
October 1, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Philippe Klee
Responsible Party
Sponsor Investigator
Principal Investigator

Philippe Klee

MD-PhD

University Hospital, Geneva

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

Outcomes

Primary Outcomes

Effect of Webdia Software use on HbA1C

Time Frame: 0, 3, 6 and 9 months after inclusion

Secondary Outcomes

  • Effect of Webdia Software use on quality of life(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)

Study Sites (1)

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