Evaluation of the DIABEO System in Poorly Controlled DM1 or DM2 Patients Treated With a Basal-bolus Insulin Regimen
NCT ID: NCT02287532
Last Updated: 2018-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
667 participants
INTERVENTIONAL
2013-02-28
2018-07-27
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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)
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
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)
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
No interventions assigned to this group
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
OTHER
Responsible Party
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Sylvia Franc
Dr Sylvia Franc, MD, VP, scientific affairs
Principal Investigators
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Sylvia FRANC, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Sud Francilien
Locations
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Centre hospitalier du Pays d'Aix
Aix-en-Provence, , France
Clinique Claude Bernard
Albi, , France
CHI d'Alencon
Alençon, , France
Centre hospitalier d'Ales
Alès, , 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
Besançon, , France
Centre hospitalier de Bethune
Béthune, , France
Centre hospitalier de Beziers
Béziers, , 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-Saône, , France
CH de Chambery
Chambéry, , 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
Étampes, , 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
Hopital Claude Huriez
Lille, , France
Cabinet médical
Lille, , France
Centre hospitalier Lons-le-Saunier
Lons-le-Saunier, , France
CHG Luneville
Lunéville, , France
Clinique BOUCHARD
Marseille, , France
Cabinet médical
Marseille, , France
Cabinet La Bastide Verte
Marseille, , France
Hopital Nord
Marseille, , France
Hopital Sainte Marguerite
Marseille, , France
Fondation Hopital Saint Joseph
Marseille, , France
Hopital de La Timone
Marseille, , France
Centre hospitalier de Meaux
Meaux, , France
Hopitaux privés de Metz
Metz, , France
Cabinet medical
Mérignac, , France
Cabinet médical
Mérignac, , France
Centre médical
Montpellier, , France
Cabinet médical d'Alco
Montpellier, , France
Hopital Lapeyronie
Montpellier, , France
hôpital Emile Muller
Mulhouse, , France
Cabinet médical
Muret, , France
Cabinet médical
Nancy, , France
Hopital Laennec - Saint Herblain
Nantes, , France
Cabinet médical
Nantes, , France
Cabinet médical
Nevers, , France
CHAN Pierre Bérégovoy
Nevers, , France
Hopital de l'Archet
Nice, , France
Cabinet médical
Nice, , France
Hopital Caremeau
Nîmes, , France
Cabinet medical
Nîmes, , France
Cabinet médical
Noisy-le-Grand, , France
Cabinet médical
Orsay, , France
Hopital Saint Louis
Paris, , France
Cabinet médical
Paris, , France
Centre hospitalier Pitié Salpetriere
Paris, , France
Hopital Bichat Claude Berbard
Paris, , France
Centre Hospitalier Francois Mitterrand
Pau, , France
Hopital Saint Jean
Perpignan, , France
Hôpital Haut Lévêque
Pessac, , France
Hôpital Saint André
Pessac, , France
Centre Hospitalier de Périgueux
Périgueux, , 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
Hopital Rangueil
Toulouse, , France
Hopital Joseph Ducuing
Toulouse, , France
Cabinet médical
Toulouse, , France
Clinique Ambroise Paré
Toulouse, , France
CH de Valence
Valence, , France
Centre hospitalier de Valenciennes
Valenciennes, , France
Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Cabinet medical
Vénissieux, , France
Countries
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References
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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.
Other Identifiers
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NCOMPL06211
Identifier Type: -
Identifier Source: org_study_id
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