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

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)

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: DIABEO software

• Study Type: Interventional
• Enrollment (Actual): 667
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aix en Provence, France, 13616
    • Centre Hospitalier du Pays d'Aix
  • Albi, France, 81030
    • Clinique Claude Bernard
  • Alencon, France, 61014
    • CHI d'Alencon
  • Ales, France, 30103
    • Centre Hospitalier d'Alès
  • Angers, France, 49933
    • Hotel Dieu
  • Antibes, France, 06600
    • Cabinet Medical
  • Argentan, France, 61200
    • Cabinet Medical
  • Argonay, France, 74370
    • Clinique d'Argonay
  • Avignon, France, 84902
    • Centre Hospitalier Henri Duffaut
  • Bagnols, France, 30205
    • Centre Hospitalier Louis Pasteur
  • Bar le Duc, France, 55012
    • CH Jeanne d'Arc
  • Bayeux, France, 14401
    • CH de Bayeux
  • Bayonne, France, 64100
    • Centre Hospitalier de la Cote Basque
  • Bayonne, France, 64100
    • Res Elgade
  • Besancon, France, 25030
    • CHU de Besancon - Hopital Jean Minjoz
  • Bethune, France, 62408
    • Centre Hospitalier de Béthune
  • Beziers, France, 34525
    • Centre Hospitalier de Beziers
  • Bordeaux, France, 33000
    • Cabinet Medical
  • Boulogne/Mer, France, 62200
    • Cabinet Medical
  • Brest, France, 29200
    • Clinique Pasteur
  • Caen, France, 14000
    • Cabinet Medical
  • Caen, France, 14000
    • Hôpital de la Côte de Nacre
  • Cahors, France, 46005
    • Centre Hospitalier Jean Rougier
  • Chalon sur Saone, France, 71100
    • Centre Hospitalier de Châlon sur Saône
  • Chambery, France, 73011
    • Ch De Chambery
  • Cherbourg Octeville, France, 50102
    • CH Louis Pasteur
  • Colmar, France, 68000
    • Cabinet Medical
  • Colomiers, France, 31770
    • Cabinet Medical
  • Contamine sur Arve, France, 74130
    • Hopital CHAL
  • Corbeil-Essonnes, France, 91100²
    • Centre Hospitalier Sud Francilien
  • Dax, France, 40100
    • Centre Hospitalier de Dax
  • Dijon, France, 21000
    • Cabinet Medical
  • Dijon, France, 21000
    • Hôpital du Bocage
  • Dole, France, 39100
    • Centre Hospitalier Louis Pasteur
  • Douai, France, 59507
    • Centre Hospitalier de Douai
  • Eaubonne, France, 95600
    • Centre Hospitalier Simone Veil
  • Etampes, France, 911542
    • Centre Hospitalier Sud Essonne Etampes
  • Fort-de-France, France, 97200
    • CHU de Fort-de-France
  • Granville, France, 50406
    • CH de Avranches Granville
  • Grenoble, France, 38000
    • Cabinet Medical
  • La Roche Sur Yon, France, 85925
    • CH Dptal Les Oudairies
  • La Rochelle, France, 17019
    • Ch Saint Louis
  • La Teste de Buch, France, 33260
    • Cabinet Medical
  • La Tronche, France, 38700
    • CHU de Grenoble - Hôpital A Michallon
  • Le Creusot, France, 71200
    • Centre Hospitalier du Creusot
  • Le Mans, France, 72037
    • CH Le Mans
  • Lille, France, 59037
    • Hopital Claude Huriez
  • Lille, France, 59000
    • Cabinet Medical
  • Lille, France, 59800
    • Cabinet Medical
  • Lons-le-Saunier, France, 39016
    • Centre hospitalier Lons-le-Saunier
  • Luneville, France, 54301
    • CHG Luneville
  • Marseille, France, 13006
    • Clinique Bouchard
  • Marseille, France, 13015
    • Hôpital Nord
  • Marseille, France, 13385
    • Hopital de la Timone
  • Marseille, France, 13274
    • Hôpital Sainte Marguerite
  • Marseille, France, 13008
    • Cabinet Medical
  • Marseille, France, 13012
    • Cabinet La Bastide Verte
  • Marseille, France, 13285
    • Fondation Hôpital Saint Joseph
  • Meaux, France, 77104
    • Centre Hospitalier de Meaux
  • Merignac, France, 33700
    • Cabinet Medical
  • Metz, France, 57045
    • Hopitaux Prives De Metz
  • Montpellier, France, 34295
    • Hopital Lapeyronie
  • Montpellier, France, 34000
    • Centre Médical
  • Montpellier, France, 34080
    • Cabinet médical d'Alco
  • Mulhouse, France, 68070
    • Hopital Emile Muller
  • Muret, France, 31700
    • Cabinet Medical
  • Mérignac, France, 33700
    • Cabinet Medical
  • Nancy, France, 54000
    • Cabinet Medical
  • Nantes, France, 44093
    • Hopital Laennec - Saint Herblain
  • Nantes, France, 44100
    • Cabinet Medical
  • Nevers, France, 58000
    • Cabinet Medical
  • Nevers, France, 58033
    • CHAN Pierre Bérégovoy
  • Nice, France, 06202
    • Hôpital de l'Archet
  • Nice, France, 06300
    • Cabinet Medical
  • Nimes, France, 30029
    • Hopital Caremeau
  • Nimes, France, 30900
    • Cabinet Medical
  • Noisy le Grand, France, 93160
    • Cabinet Medical
  • Orsay, France, 91400
    • Cabinet Medical
  • Paris, France, 75010
    • Hopital Saint Louis
  • Paris, France, 75011
    • Cabinet Medical
  • Paris, France, 75013
    • Centre Hospitalier Pitie Salpetriere
  • Paris, France, 75018
    • Hopital Bichat Claude Berbard
  • Pau, France, 64000
    • Centre hospitalier François Mitterrand
  • Perpignan, France, 66046
    • Hopital Saint Jean
  • Pessac, France, 33604
    • Hopital Haut Leveque
  • Pessac, France, 33604
    • Hopital Saint André
  • Plan de Cuques, France, 13380
    • Centre médical des spécialistes
  • Pringy, France, 74374
    • CHRA
  • Périgueux, France, 24019
    • Centre Hospitalier de Perigueux
  • Rambouillet, France, 78120
    • Centre Hospitalier de Rambouillet
  • Reims, France, 51092
    • Hôpital Robert Debré
  • Rennes, France, 35203
    • Hopital Sud Anne de Bretagne
  • Roubaix, France, 59056
    • Hopital Victor Provo
  • Saint Jean de Luz, France, 64500
    • Groupe médical ELGAR
  • Saint Priest en Jarez, France, 42270
    • CHU de Saint Etienne - Hopital Nord
  • Strasbourg, France, 67000
    • Hôpital Civil
  • Strasbourg, France, 67000
    • Cabinet de groupe
  • Tarbes, France, 65013
    • Centre Hospitalier de Bigorre Site La Gespe
  • Thionville, France, 57126
    • Hôpital Beauregard
  • Toulon, France, 83056
    • CHITS Hôpital Sainte Musse
  • Toulouse, France, 31059
    • Hopital Rangueil
  • Toulouse, France, 31076
    • Hôpital Joseph Ducuing
  • Toulouse, France, 31300
    • Cabinet Medical
  • Toulouse, France, 31300
    • Clinique Ambroise Pare
  • Valence, France, 26953
    • CH de Valence
  • Valenciennes, France, 59323
    • Centre Hospitalier de Valenciennes
  • Vandoeuvre les Nancy, France, 54511
    • Hopitaux de Brabois
  • Venissieux, France, 69200
    • Cabinet Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DIABEO software alone; Patient will have an introductory training session in the use of DIABEO by the investigating physician an will return for an on site consultation at 6 mounths (optional), 12 mounths and 24 mounths	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)
Experimental: DIABEO+paramedical telemonitoring; Patient will have an on site introductory training session in the use of DIABEO, by his/her "telemedicine" nurse from his/her region. The nurse will then follow up the patient according to a delegated tasks protocol written by the investigating physician with the nurse. Patient will be asked to return to see the investigator at 6 mounths (optional), 12 mounths and 24 mounths	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)
No Intervention: Usual Follow up; Patient will continue his/her usual follow up and return to see the investigator at 6 mounths (optional) and at the one year end of follow up for the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy data: change in HbA1c, measured at 1 year minus the value baseline	one year

Collaborators and Investigators

• Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
• Collaborators: Sanofi
• Investigators: Principal Investigator: Sylvia FRANC, MD, Centre Hospitalier Sud Francilien

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): July 27, 2018
• Study Completion (Actual): July 27, 2018

Study Registration Dates

• First Submitted: November 6, 2014
• First Submitted That Met QC Criteria: November 7, 2014
• First Posted (Estimate): November 10, 2014

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NCOMPL06211