NCT02107326

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

3.3 years

First QC Date

April 3, 2014

Last Update Submit

October 17, 2017

Conditions

Type 1 DiabetesQuality of LifeHypoglycaemia

Keywords

Type 1 diabetesHbA1CQuality of LifeHypoglycaemiaSelf-managementTelemedicine

Outcome Measures

Primary Outcomes (1)

  • Effect of Webdia Software use on HbA1C

    0, 3, 6 and 9 months after inclusion

Secondary Outcomes (2)

  • 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 Arms (2)

Webdia Software use

EXPERIMENTAL

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

Observation

NO INTERVENTION

No use of the software. No intervention.

Interventions

Webdia SoftwareDEVICE
Webdia Software use

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Previous use of Webdia Software
  • Absence of hardware necessary to install the Webdia Software

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Philippe Klee, MD-PhD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD-PhD

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 8, 2014

Study Start

May 1, 2014

Primary Completion

August 15, 2017

Study Completion

October 1, 2017

Last Updated

October 19, 2017

Record last verified: 2017-10

Locations

CH(1)