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

Diabetes Clinical Trial

— TELESAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287532
• Other study ID #: NCOMPL06211
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: July 27, 2018

Study information

• Verified date: August 2018
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: July 27, 2018
• Est. primary completion date: July 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes

Intervention

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)

Locations

Country	Name	City	State
France	Centre hospitalier du Pays d'Aix	Aix en Provence
France	Clinique Claude Bernard	Albi
France	CHI d'Alencon	Alencon
France	Centre hospitalier d'Ales	Ales
France	Hotel Dieu	Angers
France	Cabinet médical	Antibes
France	Cabinet medical	Argentan
France	Clinique D'Argonay	Argonay
France	Centre hospitalier Henri Duffaut	Avignon
France	Centre hospitalier Louis Pasteur	Bagnols
France	CH Jeanne d'Arc	Bar le Duc
France	CH de Bayeux	Bayeux
France	Centre Hospitalier de la Cote Basque	Bayonne
France	Res Elgade	Bayonne
France	CHU de Besancon - Hopital Jean Minjoz	Besancon
France	Centre hospitalier de Bethune	Bethune
France	Centre hospitalier de Beziers	Beziers
France	Cabinet médical	Bordeaux
France	Cabinet médical	Boulogne/Mer
France	Clinique Pasteur	Brest
France	Cabinet medical	Caen
France	Hopital de la Cote de Nacre	Caen
France	centre Hospitalier Jean Rougier	Cahors
France	Centre hospitalier de Chalon sur Saone	Chalon sur Saone
France	CH de Chambery	Chambery
France	CH Louis Pasteur	Cherbourg Octeville
France	Cabinet médical	Colmar
France	Cabinet médical	Colomiers
France	Hopital CHAL	Contamine sur Arve
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes
France	Centre Hospitalier de Dax	Dax
France	Cabinet médical	Dijon
France	Hopital du Bocage	Dijon
France	Centre hospitalier Louis Pasteur	Dole
France	Centre hospitalier de Douai	Douai
France	Centre hospitalier Simone Veil	Eaubonne
France	Centre Hospitalier Sud Essonne Etampes	Etampes
France	CHU de Fort-de-France	Fort-de-France
France	CH de Avranches Granville	Granville
France	Cabinet médical	Grenoble
France	CH Dptal Les Oudairies	La Roche Sur Yon
France	CH Saint Louis	La Rochelle
France	Cabinet médical	La Teste de Buch
France	CHU de Grenoble - Hopital A Michallon	La Tronche
France	Centre Hospitalier du Creusot	Le Creusot
France	CH Le Mans	Le Mans
France	Cabinet médical	Lille
France	Cabinet médical	Lille
France	Hopital Claude Huriez	Lille
France	Centre hospitalier Lons-le-Saunier	Lons-le-Saunier
France	CHG Luneville	Luneville
France	Cabinet La Bastide Verte	Marseille
France	Cabinet médical	Marseille
France	Clinique BOUCHARD	Marseille
France	Fondation Hopital Saint Joseph	Marseille
France	Hopital de La Timone	Marseille
France	Hopital Nord	Marseille
France	Hopital Sainte Marguerite	Marseille
France	Centre hospitalier de Meaux	Meaux
France	Cabinet medical	Merignac
France	Cabinet médical	Mérignac
France	Hopitaux privés de Metz	Metz
France	Cabinet médical d'Alco	Montpellier
France	Centre médical	Montpellier
France	Hopital Lapeyronie	Montpellier
France	hôpital Emile Muller	Mulhouse
France	Cabinet médical	Muret
France	Cabinet médical	Nancy
France	Cabinet médical	Nantes
France	Hopital Laennec - Saint Herblain	Nantes
France	Cabinet médical	Nevers
France	CHAN Pierre Bérégovoy	Nevers
France	Cabinet médical	Nice
France	Hopital de l'Archet	Nice
France	Cabinet medical	Nimes
France	Hopital Caremeau	Nimes
France	Cabinet médical	Noisy le Grand
France	Cabinet médical	Orsay
France	Cabinet médical	Paris
France	Centre hospitalier Pitié Salpetriere	Paris
France	Hopital Bichat Claude Berbard	Paris
France	Hopital Saint Louis	Paris
France	Centre Hospitalier Francois Mitterrand	Pau
France	Centre Hospitalier de Périgueux	Périgueux
France	Hopital Saint Jean	Perpignan
France	Hôpital Haut Lévêque	Pessac
France	Hôpital Saint André	Pessac
France	Centre médical des spécialistes	Plan de Cuques
France	CHRA	Pringy
France	Centre hospitalier de Rambouillet	Rambouillet
France	Hopital Robert Debré	Reims
France	Hopital Sud Anne de Bretagne	Rennes
France	Hopital Victor Provo	Roubaix
France	Groupe médical ELGAR	Saint Jean de Luz
France	CHU de Saint Etienne - Hopital Nord	Saint Priest en Jarez
France	Cabinet de groupe	Strasbourg
France	Hôpital Civil	Strasbourg
France	Centre hospitalier de Bigorre site La Gespe	Tarbes
France	Hopital Beauregard	Thionville
France	CHITS Hopital Sainte Musse	Toulon
France	Cabinet médical	Toulouse
France	Clinique Ambroise Paré	Toulouse
France	Hopital Joseph Ducuing	Toulouse
France	Hopital Rangueil	Toulouse
France	CH de Valence	Valence
France	Centre hospitalier de Valenciennes	Valenciennes
France	Hopitaux de Brabois	Vandoeuvre les Nancy
France	Cabinet medical	Venissieux

Sponsors (2)

Lead Sponsor	Collaborator
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète	Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy data: change in HbA1c, measured at 1 year minus the value baseline		one year