Clinical trial NCT02287532: Evaluation of the DIABEO System in Poorly Controlled DM1 or DM2 Patients Treated With a Basal-bolus Insulin Regimen
Official title: Evaluation of the DIABEO System in Poorly Controlled DM1 or DM2 Patients Treated With a Basal-bolus Insulin Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2014-11-10
Enrollment: 667
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy data: change in HbA1c, measured at 1 year minus the value baseline
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Centre hospitalier du Pays d'Aix
city: Albi
country: France
facility: Clinique Claude Bernard
city: Alencon
country: France
facility: CHI d'Alencon
city: Ales
country: France
facility: Centre hospitalier d'Ales
city: Angers
country: France
facility: Hotel Dieu
city: Antibes
country: France
facility: Cabinet médical
city: Argentan
country: France
facility: Cabinet medical
city: Argonay
country: France
facility: Clinique D'Argonay
city: Avignon
country: France
facility: Centre hospitalier Henri Duffaut
city: Bagnols
country: France
facility: Centre hospitalier Louis Pasteur
city: Bar le Duc
country: France
facility: CH Jeanne d'Arc
city: Bayeux
country: France
facility: CH de Bayeux
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque
city: Bayonne
country: France
facility: Res Elgade
city: Besancon
country: France
facility: CHU de Besancon - Hopital Jean Minjoz
city: Bethune
country: France
facility: Centre hospitalier de Bethune
city: Beziers
country: France
facility: Centre hospitalier de Beziers
city: Bordeaux
country: France
facility: Cabinet médical
city: Boulogne/Mer
country: France
facility: Cabinet médical
city: Brest
country: France
facility: Clinique Pasteur
city: Caen
country: France
facility: Cabinet medical
city: Caen
country: France
facility: Hopital de la Cote de Nacre
city: Cahors
country: France
facility: centre Hospitalier Jean Rougier
city: Chalon sur Saone
country: France
facility: Centre hospitalier de Chalon sur Saone
city: Chambery
country: France
facility: CH de Chambery
city: Cherbourg Octeville
country: France
facility: CH Louis Pasteur
city: Colmar
country: France
facility: Cabinet médical
city: Colomiers
country: France
facility: Cabinet médical
city: Contamine sur Arve
country: France
facility: Hopital CHAL
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Dax
country: France
facility: Centre Hospitalier de Dax
city: Dijon
country: France
facility: Cabinet médical
city: Dijon
country: France
facility: Hopital du Bocage
city: Dole
country: France
facility: Centre hospitalier Louis Pasteur
city: Douai
country: France
facility: Centre hospitalier de Douai
city: Eaubonne
country: France
facility: Centre hospitalier Simone Veil
city: Etampes
country: France
facility: Centre Hospitalier Sud Essonne Etampes
city: Fort-de-France
country: France
facility: CHU de Fort-de-France
city: Granville
country: France
facility: CH de Avranches Granville
city: Grenoble
country: France
facility: Cabinet médical
city: La Roche Sur Yon
country: France
facility: CH Dptal Les Oudairies
city: La Rochelle
country: France
facility: CH Saint Louis
city: La Teste de Buch
country: France
facility: Cabinet médical
city: La Tronche
country: France
facility: CHU de Grenoble - Hopital A Michallon
city: Le Creusot
country: France
facility: Centre Hospitalier du Creusot
city: Le Mans
country: France
facility: CH Le Mans
city: Lille
country: France
facility: Cabinet médical
city: Lille
country: France
facility: Hopital Claude Huriez
city: Lille
country: France
facility: Cabinet médical
city: Lons-le-Saunier
country: France
facility: Centre hospitalier Lons-le-Saunier
city: Luneville
country: France
facility: CHG Luneville
city: Marseille
country: France
facility: Clinique BOUCHARD
city: Marseille
country: France
facility: Cabinet médical
city: Marseille
country: France
facility: Cabinet La Bastide Verte
city: Marseille
country: France
facility: Hopital Nord
city: Marseille
country: France
facility: Hopital Sainte Marguerite
city: Marseille
country: France
facility: Fondation Hopital Saint Joseph
city: Marseille
country: France
facility: Hopital de La Timone
city: Meaux
country: France
facility: Centre hospitalier de Meaux
city: Merignac
country: France
facility: Cabinet medical
city: Metz
country: France
facility: Hopitaux privés de Metz
city: Montpellier
country: France
facility: Centre médical
city: Montpellier
country: France
facility: Cabinet médical d'Alco
city: Montpellier
country: France
facility: Hopital Lapeyronie
city: Mulhouse
country: France
facility: hôpital Emile Muller
city: Muret
country: France
facility: Cabinet médical
city: Mérignac
country: France
facility: Cabinet médical
city: Nancy
country: France
facility: Cabinet médical
city: Nantes
country: France
facility: Hopital Laennec - Saint Herblain
city: Nantes
country: France
facility: Cabinet médical
city: Nevers
country: France
facility: Cabinet médical
city: Nevers
country: France
facility: CHAN Pierre Bérégovoy
city: Nice
country: France
facility: Hopital de l'Archet
city: Nice
country: France
facility: Cabinet médical
city: Nimes
country: France
facility: Hopital Caremeau
city: Nimes
country: France
facility: Cabinet medical
city: Noisy le Grand
country: France
facility: Cabinet médical
city: Orsay
country: France
facility: Cabinet médical
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Cabinet médical
city: Paris
country: France
facility: Centre hospitalier Pitié Salpetriere
city: Paris
country: France
facility: Hopital Bichat Claude Berbard
city: Pau
country: France
facility: Centre Hospitalier Francois Mitterrand
city: Perpignan
country: France
facility: Hopital Saint Jean
city: Pessac
country: France
facility: Hôpital Haut Lévêque
city: Pessac
country: France
facility: Hôpital Saint André
city: Plan de Cuques
country: France
facility: Centre médical des spécialistes
city: Pringy
country: France
facility: CHRA
city: Périgueux
country: France
facility: Centre Hospitalier de Périgueux
city: Rambouillet
country: France
facility: Centre hospitalier de Rambouillet
city: Reims
country: France
facility: Hopital Robert Debré
city: Rennes
country: France
facility: Hopital Sud Anne de Bretagne
city: Roubaix
country: France
facility: Hopital Victor Provo
city: Saint Jean de Luz
country: France
facility: Groupe médical ELGAR
city: Saint Priest en Jarez
country: France
facility: CHU de Saint Etienne - Hopital Nord
city: Strasbourg
country: France
facility: Cabinet de groupe
city: Strasbourg
country: France
facility: Hôpital Civil
city: Tarbes
country: France
facility: Centre hospitalier de Bigorre site La Gespe
city: Thionville
country: France
facility: Hopital Beauregard
city: Toulon
country: France
facility: CHITS Hopital Sainte Musse
city: Toulouse
country: France
facility: Hopital Rangueil
city: Toulouse
country: France
facility: Hopital Joseph Ducuing
city: Toulouse
country: France
facility: Cabinet médical
city: Toulouse
country: France
facility: Clinique Ambroise Paré
city: Valence
country: France
facility: CH de Valence
city: Valenciennes
country: France
facility: Centre hospitalier de Valenciennes
city: Vandoeuvre les Nancy
country: France
facility: Hopitaux de Brabois
city: Venissieux
country: France
facility: Cabinet medical
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Sylvia FRANC, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeandidier N, Chaillous L, Franc S, Benhamou PY, Schaepelynck P, Hanaire H, Catargi B, Farret A, Fontaine P, Guerci B, Reznik Y, Penfornis A, Borot S, Serusclat P, Kherbachi Y, D'Orsay G, Detournay B, Simon P, Charpentier G. DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 19;7(4):e66. doi: 10.2196/resprot.9154.