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

October 17, 2017 updated by: Philippe Klee

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • GE
      • Geneva, GE, Switzerland, 1211
        • University Hospital of Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Webdia Software use
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.
Device: Webdia Software
No Intervention: Observation
No use of the software. No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of Webdia Software use on HbA1C
Time Frame: 0, 3, 6 and 9 months after inclusion
0, 3, 6 and 9 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Webdia Software use on quality of life
Time Frame: 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.
0, 3, 6 and 9 months after inclusion
Effect of Webdia Software use on the incidence of hypoglycaemic events
Time Frame: During 2 weeks at the end of the 3-months period of Webdia Software use
During 2 weeks at the end of the 3-months period of Webdia Software use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philippe Klee

Investigators

  • Principal Investigator: Philippe Klee, MD-PhD, University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

August 15, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

April 3, 2014

First Submitted That Met QC Criteria

April 7, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Actual)

October 19, 2017

Last Update Submitted That Met QC Criteria

October 17, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER13-272

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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