Evaluation of the DIABEO System in Poorly Controlled DM1 or DM2 Patients Treated With a Basal-bolus Insulin Regimen

The aim of the TELESAGE study is to demonstrate

1. the superiority of follow up with the DIABEO system (software alone) versus usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a basal-bolus insulin regimen. 2. the superiority of follow up with the DIABEO system (software + telemonitoring) compared to usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a basal-bolus insulin regimen.

The DIABEO software alone is an electronic diary system incorporating an immediate automatic aid to calculating the insulin dose according to the prescription given by the doctor, and a data processing, automated analysis message and secure internet data transfer system.

The DIABEO software added by paramedical telemonitoring is the electronic diary combined with remote paramedical monitoring of data (telemeonitoring)

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier du Pays d'Aix, Aix-en-Provence, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Type 1 or type 2 diabetic patients
Performing auto-glycaemic control (at least 2 glycemias a day)
Treated with insulin by a basal-bolus regimen for at least 1 year and using the same method of administration for at least 3 months (insulin pen or pump)
Who have an Apple® or Androïde® Smartphone compatible, or intend to acquire one before their participation in the study
Whose HbA1c dating of less 1 month and more than 3 months is ≥ 8%
Who are able to understand and follow the study protocol
Who have given their signed consent to take part in the study
Subject affiliated to the French National Health Insurance funds or benefiting from such insurance

Exclusion criteria

Age < 18 years old
Patients who have used the DIABEO system within 6 months before inclusion
Participation in a clinical study within 6 months, except for the Meos (or télédiab 3) study after a participation period of 6 months
Patients who are pregnant or who wish to become pregnant during the study.
Patients treated with human insulin A patient pre-screening register will be set up in each centre to establish the reasons for DM1/DM2 patients treated with a basal-bolus insulin regimen who are not taking part in the study.

Treatment and study plan

DIABEO software

Device

DIABEO is an electronic diary system incorporating an immediate automatic aid to calculating the insulin dose according to the prescription given by the doctor, and a data processing, automated analysis message and secure internet data transfer system. DIABEO software could be combined with remote paramedical monitoring of data (telemonitoring)

Primary outcomes

Efficacy data: change in HbA1c, measured at 1 year minus the value baseline

Time frame: one year

Sponsors and collaborators

Lead sponsor

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Other

Collaborators

Sanofi

Registry information

Acronym: TELESAGE

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2018
First posted: Nov 10, 2014
Registry last updated: Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed