NCT02287532

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 667 (actual)
• Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	DIABEO software	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)

Timeline

• Start date: 2013-02-01
• Primary completion: 2018-07-27
• Completion: 2018-07-27
• First posted: 2014-11-10
• Last updated: 2018-08-21

Locations

108 sites across 1 country: France