DiabetesTELESAGENCT02287532
Evaluation of the DIABEO System in Poorly Controlled DM1 or DM2 Patients Treated With a Basal-bolus Insulin Regimen
A study testing DIABEO software in people with Diabetes, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 108 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- DIABEO software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 667 participants
- Where
- 108 sitesFrance
- Study dates
- Feb 2013to 27 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
108 sites in 1 country.
108 sites in 1 country
France108 sites
Centre hospitalier du Pays d'Aix
Aix-en-Provence, 13616
Clinique Claude Bernard
Albi, 81030
CHI d'Alencon
Alençon, 61014
Centre hospitalier d'Ales
Alès, 30103
Hotel Dieu
Angers, 49933
Cabinet médical
Antibes, 06600
Cabinet medical
Argentan, 61200
Clinique D'Argonay
Argonay, 74370
Centre hospitalier Henri Duffaut
Avignon, 84902
Centre hospitalier Louis Pasteur
Bagnols, 30205
CH Jeanne d'Arc
Bar-le-Duc, 55012
CH de Bayeux
Bayeux, 14401
Centre Hospitalier de la Cote Basque
Bayonne, 64100
Res Elgade
Bayonne, 64100
CHU de Besancon - Hopital Jean Minjoz
Besançon, 25030
Centre hospitalier de Bethune
Béthune, 62408
Centre hospitalier de Beziers
Béziers, 34525
Cabinet médical
Bordeaux, 33000
Cabinet médical
Boulogne/Mer, 62200
Clinique Pasteur
Brest, 29200
Cabinet medical
Caen, 14000
Hopital de la Cote de Nacre
Caen, 14000
centre Hospitalier Jean Rougier
Cahors, 46005
Centre hospitalier de Chalon sur Saone
Chalon-sur-Saône, 71100
CH de Chambery
Chambéry, 73011
CH Louis Pasteur
Cherbourg Octeville, 50102
Cabinet médical
Colmar, 68000
Cabinet médical
Colomiers, 31770
Hopital CHAL
Contamine-sur-Arve, 74130
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100²
Centre Hospitalier de Dax
Dax, 40100
Cabinet médical
Dijon, 21000
Hopital du Bocage
Dijon, 21000
Centre hospitalier Louis Pasteur
Dole, 39100
Centre hospitalier de Douai
Douai, 59507
Centre hospitalier Simone Veil
Eaubonne, 95600
Centre Hospitalier Sud Essonne Etampes
Étampes, 911542
CHU de Fort-de-France
Fort-de-France, 97200
CH de Avranches Granville
Granville, 50406
Cabinet médical
Grenoble, 38000
CH Dptal Les Oudairies
La Roche-sur-Yon, 85925
CH Saint Louis
La Rochelle, 17019
Cabinet médical
La Teste-de-Buch, 33260
CHU de Grenoble - Hopital A Michallon
La Tronche, 38700
Centre Hospitalier du Creusot
Le Creusot, 71200
CH Le Mans
Le Mans, 72037
Cabinet médical
Lille, 59000
Hopital Claude Huriez
Lille, 59037
Cabinet médical
Lille, 59800
Centre hospitalier Lons-le-Saunier
Lons-le-Saunier, 39016
CHG Luneville
Lunéville, 54301
Clinique BOUCHARD
Marseille, 13006
Cabinet médical
Marseille, 13008
Cabinet La Bastide Verte
Marseille, 13012
Hopital Nord
Marseille, 13015
Hopital Sainte Marguerite
Marseille, 13274
Fondation Hopital Saint Joseph
Marseille, 13285
Hopital de La Timone
Marseille, 13385
Centre hospitalier de Meaux
Meaux, 77104
Cabinet medical
Mérignac, 33700
Cabinet médical
Mérignac, 33700
Hopitaux privés de Metz
Metz, 57045
Centre médical
Montpellier, 34000
Cabinet médical d'Alco
Montpellier, 34080
Hopital Lapeyronie
Montpellier, 34295
hôpital Emile Muller
Mulhouse, 68070
Cabinet médical
Muret, 31700
Cabinet médical
Nancy, 54000
Hopital Laennec - Saint Herblain
Nantes, 44093
Cabinet médical
Nantes, 44100
Cabinet médical
Nevers, 58000
CHAN Pierre Bérégovoy
Nevers, 58033
Hopital de l'Archet
Nice, 06202
Cabinet médical
Nice, 06300
Hopital Caremeau
Nîmes, 30029
Cabinet medical
Nîmes, 30900
Cabinet médical
Noisy-le-Grand, 93160
Cabinet médical
Orsay, 91400
Hopital Saint Louis
Paris, 75010
Cabinet médical
Paris, 75011
Centre hospitalier Pitié Salpetriere
Paris, 75013
Hopital Bichat Claude Berbard
Paris, 75018
Centre Hospitalier Francois Mitterrand
Pau, 64000
Centre Hospitalier de Périgueux
Périgueux, 24019
Hopital Saint Jean
Perpignan, 66046
Hôpital Haut Lévêque
Pessac, 33604
Hôpital Saint André
Pessac, 33604
Centre médical des spécialistes
Plan-de-Cuques, 13380
CHRA
Pringy, 74374
Centre hospitalier de Rambouillet
Rambouillet, 78120
Hopital Robert Debré
Reims, 51092
Hopital Sud Anne de Bretagne
Rennes, 35203
Hopital Victor Provo
Roubaix, 59056
Groupe médical ELGAR
Saint-Jean-de-Luz, 64500
CHU de Saint Etienne - Hopital Nord
Saint-Priest-en-Jarez, 42270
Cabinet de groupe
Strasbourg, 67000
Hôpital Civil
Strasbourg, 67000
Centre hospitalier de Bigorre site La Gespe
Tarbes, 65013
Hopital Beauregard
Thionville, 57126
CHITS Hopital Sainte Musse
Toulon, 83056
Hopital Rangueil
Toulouse, 31059
Hopital Joseph Ducuing
Toulouse, 31076
Cabinet médical
Toulouse, 31300
Clinique Ambroise Paré
Toulouse, 31300
CH de Valence
Valence, 26953
Centre hospitalier de Valenciennes
Valenciennes, 59323
Hopitaux de Brabois
Vandœuvre-lès-Nancy, 54511
Cabinet medical
Vénissieux, 69200
About this study
The aim of the TELESAGE study is to demonstrate
- 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.
- 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.
Read more
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
- Being tested
- DIABEO software
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIABEO softwareDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| DIABEO software alone | Experimental | 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 Receives: Device: DIABEO software |
| DIABEO+paramedical telemonitoring | Experimental | 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 Receives: Device: DIABEO software |
| Usual Follow up | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Efficacy data: change in HbA1c, measured at 1 year minus the value baseline
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startFeb 2013
- Primary completion27 Jul 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Sylvia Franc, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Investigators
- Sylvia FRANC, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287532
- Sponsor's protocol ID
- NCOMPL06211
- Acronym
- TELESAGE
- Status last verified
- Aug 2018
- First submitted
- 6 Nov 2014
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29674306
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the DIABEO System in Poorly Controlled DM1 or DM2 Patients Treated With a Basal-bolus Insulin Regimen
- ClinicalTrials.gov ID
- NCT02287532
- Acronym / sponsor ID
- TELESAGE / NCOMPL06211
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Feb 2013
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the TELESAGE study is to demonstrate
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DIABEO software alone | Experimental | Device: DIABEO softwarePatient 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+paramedical telemonitoring | Experimental | Device: DIABEO softwarePatient 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 |
| Usual Follow up | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIABEO softwareDIABEO 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) | Device | DIABEO software alone, DIABEO+paramedical telemonitoring |
Primary outcome
Efficacy data: change in HbA1c, measured at 1 year minus the value baseline
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Derived from this study: PubMed 29674306Jeandidier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvia FRANC, MD principal investigator
Centre Hospitalier Sud Francilien
108 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIABEO software in people with Diabetes, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 108 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 108 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy data: change in HbA1c, measured at 1 year minus the value baseline (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02287532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.