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

Primary Purpose

Type 1 Diabetes, Quality of Life, Hypoglycaemia

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Webdia Software
Sponsored by
Philippe Klee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, HbA1C, Quality of Life, Hypoglycaemia, Self-management, Telemedicine

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Geneva

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Webdia Software use

Observation

Arm Description

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.

No use of the software. No intervention.

Outcomes

Primary Outcome Measures

Effect of Webdia Software use on HbA1C

Secondary Outcome Measures

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.
Effect of Webdia Software use on the incidence of hypoglycaemic events

Full Information

First Posted
April 3, 2014
Last Updated
October 17, 2017
Sponsor
Philippe Klee
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1. Study Identification

Unique Protocol Identification Number
NCT02107326
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 15, 2017 (Actual)
Study Completion Date
October 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Philippe Klee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Quality of Life, Hypoglycaemia
Keywords
Type 1 diabetes, HbA1C, Quality of Life, Hypoglycaemia, Self-management, Telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Webdia Software use
Arm Type
Experimental
Arm Description
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.
Arm Title
Observation
Arm Type
No Intervention
Arm Description
No use of the software. No intervention.
Intervention Type
Device
Intervention Name(s)
Webdia Software
Primary Outcome Measure Information:
Title
Effect of Webdia Software use on HbA1C
Time Frame
0, 3, 6 and 9 months after inclusion
Secondary Outcome Measure Information:
Title
Effect of Webdia Software use on quality of life
Description
Quality of life assessment by the use of the Diabetes Quality of Life for Youths (DQOLY) questionnaire published by Ingersoll et al. 1991.
Time Frame
0, 3, 6 and 9 months after inclusion
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Klee, MD-PhD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Geneva
City
Geneva
State/Province
GE
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
http://www.webdia.ch
Description
Homepage of the Webdia Software being tested in this study

Learn more about this trial

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

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