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

NCT ID: NCT02107326

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-10-01

Brief Summary

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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

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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.

Conditions

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Type 1 Diabetes Quality of Life Hypoglycaemia

Keywords

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Type 1 diabetes HbA1C Quality of Life Hypoglycaemia Self-management Telemedicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Webdia Software

Intervention Type DEVICE

Observation

No use of the software. No intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Webdia Software

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philippe Klee

OTHER

Sponsor Role lead

Responsible Party

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Philippe Klee

MD-PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Philippe Klee, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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University Hospital of Geneva

Geneva, Canton of Geneva, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CER13-272

Identifier Type: -

Identifier Source: org_study_id