Multicentric Evaluation of Two Telematics Systems in Type 2 Diabetic Patients in Failure of Oral Treatment and Having to Start Treatment by Basal Insulin
NCT ID: NCT00937703
Last Updated: 2013-12-13
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
180 participants
INTERVENTIONAL
2008-12-31
2013-05-31
Brief Summary
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Main judgment criteria: comparison of HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group at 4 months.
Detailed Description
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1. \- To compare the 2 methods of telemonitoring employed.
2. \- To evaluate the speed of the glycemic attack of the objective to the rising, according to the method of follow-up employed.
3. \- To evaluate the satisfaction of the patients and the doctors with respect to systems of telemonitoring, and improvement of the quality of life (DQOL).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group1: Control group
face to face visit à T4mounths
placebo
paper support for glycaemia face to face visit at T4mounths
Group2: IVS Group
face to face visit at T4mounths plus telephone visits each 2 weeks
IVS
patients transmit their glycaemia to the IVS, which advises them the insulin amount recommended by their physician in this situation.
Face to face visit at T4mounths plus telephone visits each 2 weeks.
Group3: PDAphone group
PDA system face to face visit at T4mounths plus telephone visits each 2 weeks
PDAphone
Patients will receive PDA phone system. They will hace face to face visit at T4mounths and telephone visits each 2 weeks
Interventions
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placebo
paper support for glycaemia face to face visit at T4mounths
IVS
patients transmit their glycaemia to the IVS, which advises them the insulin amount recommended by their physician in this situation.
Face to face visit at T4mounths plus telephone visits each 2 weeks.
PDAphone
Patients will receive PDA phone system. They will hace face to face visit at T4mounths and telephone visits each 2 weeks
Eligibility Criteria
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Inclusion Criteria
* Patients treated since at least 3 months, by metformin and secreting insulinic (KNOWN or glinide);
* Patients uncontrolled with HbA1c ≥ 7.5% and \< 10% at the inclusion.
* BMI \< 40 ;
* Patients requiring a insulin treatment
* Patients agree to start a slow insulin treatment
* Patients already practising the glycemic self-monitoring or agree to learn it and practise it;
* Patients able to include/understand operation and to use the PDA-phone and/or the SVI;
* Patient not taking part in another biomedical research study
* Patients agree to carry out at least 2 finger sticks per day;
* More than 18 years, there is no higher age limit.
Exclusion Criteria
* Patients in a situation which justifies of a clinical follow-up diabetologic more frequent than that (quarterly) envisaged by the study
* Patients requiring a transitory passage to insulin;
* Patients needing a hospitalization for the adaptation of insulin doses;
* Patients presenting a cardiologic event
* Patients presenting a hemoglobinopathy interfering with the proportioning of HbA1c;
* Patients suffering from drug-addiction, alcoholism or psychological troubles
* Type 1 or secondary diabetes
* Patients who don't need strict metabolic objectives;
* Pregnant or parturient patients
* person with no freedom.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
OTHER
Responsible Party
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Principal Investigators
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Guillaume CHARPENTIER, MD
Role: STUDY_CHAIR
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Pierre Yves BENHAMOU, MD PHD
Role: STUDY_CHAIR
University Hospital, Grenoble
Locations
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CH Aix en Provence
Aix-en-Provence, , France
Centre Hospitalier Intercommunal Alençon-Mamers
Alençon, , France
CH Avignon
Avignon, , France
Centre Hospitalier de Belfort Montbéliard
Belfort, , France
CHU Jean Minjoz
Besançon, , France
CHU de Caen
Caen, , France
Hôpital Gabriel Montpied
Clermont-Ferrand, , France
CH sud francilien
Corbeil-Essonnes, , France
CH de Dreux
Dreux, , France
CHU Pierre Zobda-Quitman
Fort de France, , France
University Hospital Grenoble
Grenoble, , France
CH La Rochelle
La Rochelle, , France
CHU de Bicêtre
Le Kremlin-Bicêtre, , France
CHU Marseille-Hôpital Nord
Marseille, , France
CHU Marseille Hôpitaux Sud
Marseille, , France
CH de l'Agglomération Montargoise
Montagis, , France
CHU Hôpital Jeanne d'Arc
Nancy, , France
CH Nanterre
Nanterre, , France
CHU Nantes
Nantes, , France
CHU de Nimes
Nîmes, , France
Hopital COCHIN
Paris, , France
Hopital Haut Leveque
Pessac, , France
CHU de Poitiers
Poitiers, , France
CHU Rennes
Rennes, , France
CHU de Saint Etienne
Saint-Etienne, , France
Hôpital Bégin
Saint-Mandé, , France
Centre Hospitalier Strasbourg
Strasbourg, , France
Ch Valenciennes
Valenciennes, , France
Countries
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Other Identifiers
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2008-A00270-55
Identifier Type: -
Identifier Source: org_study_id