Effectiveness and Cost-effectiveness of a Telemonitoring Program for Diabetic People at Home (EDUC@DOM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01955031
First received: August 22, 2013
Last updated: August 18, 2015
Last verified: August 2015
  Purpose

Severity of diabetes is related to the development of disabling and costly complications (12.9 billion euros in 2007). The French High Health Authority recommends a therapeutic education on lifestyle and dietary rules in first-line treatment of Type 2 Diabetes Mellitus. Despite these recommendations, patients often have difficulties to implement dietary recommendations every day. The objective of EDUC@DOM is to help people with diabetes to improve lifestyle and equilibrium of glycaemia in order to avoid or delay chronic complications of diabetes. Our main goal is to assess effectiveness of our telemonitoring program in type 2 patients' care compared to a usual care of diabetes, on the glycaemia of the patients. It is expected that our program leads to a better monitoring of health status, a greater adherence to medical and non-medical prescriptions, an empowerment of the patient, and as a consequence, a more efficient health care consumption.


Condition Intervention
Type 2 Diabetes
Other: telemonitoring
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effectiveness and Cost-effectiveness Analysis of a Telemonitoring Program on Lifestyle for People With Type 2 Diabetes at Home. Study Based on a Health Network in Diabetology.

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • To assess effectiveness of our telemonitoring program in Diabetes care, HbA1C assays will be compared between the two groups.The change of HbA1c between day 0, month 1,month 3, month 6, month 9 and month 12 [ Time Frame: HbA1c will be measured at Day 0, month 1, month 3, month 6, month 9 and month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment efficacy of our program by the measure of HbA1C will [ Time Frame: At month 15, month 18, month 21 and month 24 ] [ Designated as safety issue: No ]
  • Questionnaires will be given to patients to assess the improvement of nutritional knowledge [ Time Frame: At day 0 and month 24 ] [ Designated as safety issue: No ]
  • Food inquiries will be given to patients to assess the improvement of eating habits [ Time Frame: At day 0 and month 24 ] [ Designated as safety issue: No ]
  • Questionnaires will be given to patients to assess the physical activity practice [ Time Frame: At day 0 and month 24 ] [ Designated as safety issue: No ]
  • Waist circumference will be measured to assess the body composition, BMI (Body Mass Index), [ Time Frame: At day 0 and month 24 ] [ Designated as safety issue: No ]
  • The self-monitoring blood glucose books will be copied to assess mean of blood glycaemia [ Time Frame: At day 0, month 12 and month 24 ] [ Designated as safety issue: No ]
  • A blood sample will be collected to assess lipid status [ Time Frame: At day 0 and month 24 ] [ Designated as safety issue: No ]
  • Two questionnaires will be given to patients to assess quality of life of patients [ Time Frame: At day 0 and month 24 ] [ Designated as safety issue: No ]
  • A cost-effectiveness ratio and a markov modelisation will be realized to assess the economic aspects [ Time Frame: At month 24 ] [ Designated as safety issue: No ]
  • For the telemonitoring arm, assessment of food behavior through meals registered with the Nutri-Educ software [ Time Frame: Everytime patients use the software from Day 0 to month 24 ] [ Designated as safety issue: No ]
  • For the telemonitoring arm, assessment of nutritional knowledge through rate of good choices playing games of Nutri-Kiosk software [ Time Frame: Everytime patients use the software from Day0 to month 24 ] [ Designated as safety issue: No ]
  • For the telemonitoring arm, assessment of physical activity declared through Acti-Kiosk software and measures collected with the pedometer (number of steps, number of stairs climbed up) [ Time Frame: Every time patients use the software and the pedometer from day 0 to month 24 ] [ Designated as safety issue: No ]
  • For the telemonitoring arm, measure of weight, fat rate and lean rate collected with the balance [ Time Frame: Everytime patients use the balance from day 0 to month 24 ] [ Designated as safety issue: No ]
  • For the telemonitoring arm, means of glycaemia collected with the self-monitoring blood glucose device [ Time Frame: Everytime patients use the blood glucose device from day 0 to month 24 ] [ Designated as safety issue: No ]
  • For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the patients with the number and time of connections and a questionnaire [ Time Frame: At month 24 ] [ Designated as safety issue: No ]
  • For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the health professionals with the number and time of connections [ Time Frame: At month 24 ] [ Designated as safety issue: No ]
  • For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the health professionals with the number and time of connections leading to a medical decision (phone call or medical appointment) and a questionnaire [ Time Frame: At month 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 282
Study Start Date: November 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telemonitoring Other: telemonitoring
A telemonitoring program with educational tools is given to people with type 2 diabetes at their home. It is composed of three softwares to improve eating habits available on touchpad, a self-monitoring blood glucose device, a balance to measure weight and fat mass, and a pedometer to evaluate physical activity. Data are securely sent and stored into a web service which delivers a synthesis to patients and health professionals.
Sham Comparator: Usual care Other: Usual care
Patients are recruited during therapeutic educational sessions or appointments by general practitioners or diabetologists who take part into the Regional Health Network in Diabetes DIAMIP. If patients accept to participate to the study and sign up the protocol consent, they are given questionnaires about nutrition, physical activity and quality of life. A dietician analyses with each patient the results of a food inquiry. Patients are randomised into two groups: one arm is trained to the telemonitoring program before receiving it at home, and the other arm follows usual care. During 12 months, the telemonitoring group uses the device. The investigators (GP or diabetologists) can use the specific secured website to follow the measured parameters and to make appropriate decisions about health care of their patient. No consultation are scheduled in advance.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with type 2 diabetes
  • Older than 18 years
  • With an insulin treatment or not
  • Having a glycemic impairment characterized by 6.5% <HbA1c ≤10
  • Having an active internet connection at home.
  • Accepting the terms of training, loan and use of the device
  • Benefiting from social protection system
  • Having given his/her free and informed consent and signed the consent

Exclusion Criteria:

  • Serious illness recently (<3 months) or decompensated may influence glycemic control of the patient permanently according to the judgment of the physician in charge of monitoring
  • Retinal state that does not allow optimization in equilibrium of glycaemia
  • Known severe renal impairment defined by creatinine clearance <30ml/min
  • Known hemoglobinopathy
  • Visual or intellectual resulting inability to use the remote monitoring tool according to the judgment of the physician in charge of monitoring
  • Inability to understand all or part of the software information according to the judgment of the physician in charge of monitoring
  • Subject to disabled
  • Person with severe behavioral disorders (anorexia, bulimia, ...) according to the judgment of the physician in charge of monitoring
  • Person who had, or in preparation for bariatric surgery (software nutrition education are not suitable for this type of care.)
  • Person with a medical device implanted electronic pacemakers and defibrillators with cardiac (possibility of interference with the impedance)
  • Another person involved in research including a period of ongoing exclusion to inclusion,
  • A person under legal protection
  • Subject living in institutions
  • Desire for pregnancy, pregnancy or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01955031

Contacts
Contact: Marie-Christine TURNIN, MD 05 61 32 22 74 ext 33 turnin.mc@chu-toulouse.fr
Contact: Solène SCHIRR-BONANS, Project manager 05 61 32 20 35 ext 33 schirr-bonans.s@chu-toulouse.fr

Locations
France
University Hospitals of Toulouse (Rangueil and Salies-Du-Salat) Recruiting
Toulouse, Midi-Pyrénées, France, 31059
Contact: Marie-Christine TURNIN, MD    05 61 32 38 16 ext 33    turnin.mc@chu-toulouse.fr   
Contact: Solène SCHIRR-BONNANS, Project manager    05 61 32 20 35 ext 33    schirr-bonnans.s@chu-toulouse.fr   
Principal Investigator: Marie-Christine TURNIN, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Marie-Christine TURNIN, MD University Hospital of Toulouse
  More Information

Additional Information:
Publications:
InVS (Institut de veille sanitaire). Fagot-Campagna Anne, Romon Isabelle, Fosse Sandrine, Roudier Candice. Prévalence et incidence du diabète, et mortalité liée au diabète en France Synthèse épidémiologique. Novembre 2010
HAS (Haute Autorité de Santé). Agence Nationale de sécurité du médicament et des produits de santé. Recommandations de bonne pratique. Stratégie médicamenteuse du contrôle glycémique du diabète de type 2. Janvier 2013.
HAS (Haute Autorité de Santé). Rapport d'orientation - Développement de la prescription de thérapeutiques non médicamenteuses validées - Avril 2011
INPES (Institut National de Prévention et d'Education pour la Santé). Labalette Céline, Buttet Pierre, Marchand Annie-Claude - DDESET. L'éducation thérapeutique du patient dans les schémas régionaux d'organisation sanitaire de 3e génération 2006-2011. Education thérapeutique du patient dans les Sros 3-INPES- 2007
HAS (Haute Autorité de Santé) et INPES (Institut National de Prévention et d'Education pour la Santé). Guide Méthodologique. Structuration d'un programme d'éducation thérapeutique du patient dans le champ des maladies chroniques. Juin 2007
MINISTÈRE DE LA SANTÉ ET DES SPORTS - Décret no 2010-904 du 2 août 2010 relatif aux conditions d'autorisation des programmes d'éducation thérapeutique du patient, - Décret no 2010-906 du 2 août 2010 relatif aux compétences requises pour dispenser l'éducation thérapeutique du patient - Arrêté du 2 août 2010 relatif aux compétences requises pour dispenser l'éducation thérapeutique du patient - Arrêté du 2 août 2010 relatif au cahier des charges des programmes d'éducation thérapeutique du patient et à la composition du dossier de demande de leur autorisation
Franc S., Dardari D., Boucherie B., Daoudi A., Charpentier G. La télémédecine appliquée au diabète : les résultats acquis et les perspectives à venir. Médecine des maladies Métaboliques, Vol 4, No 3, 2010.
Paré Guy, Moqadem Khalil, Pineau Gilles, St-Hilaire Carole. Revue systématique des effets de la télésurveillance à domicile dans le contexte du diabète, des maladies pulmonaires et des maladies cardiovasculaires. AGENCE D'ÉVALUATION DES TECHNOLOGIES ET DES MODES D'INTERVENTION EN SANTÉ. Québec. ETMIS 2009; VOL. 5 : NO 3.
Guide Affection de Longue Durée (ALD 8) - Diabète de type 2 - Guide Médecin - juillet 2007
Buisson J.-C., Garel A. Balancing Meals Using Fuzzy Arithmetics and Heuristic Search Algorithms. IEEE Transactions on Fuzzy Systems, IEEE, Vol. 11 N. 1, p. 68-78, 2003.
Haute Autorité de Santé. BON USAGE DES TECHNOLOGIES DE SANTÉ. L'autosurveillance glycémique dans le diabète de type 2 : une utilisation très ciblée. Avril 2011
MINISTÈRE DU TRAVAIL, DE L'EMPLOI ET DE LA SANTÉ. Arrêté du 25 février 2011 relatif à la modification des conditions de prise en charge des appareils pour lecture automatique de la glycémie, dits lecteurs de glycémie, inscrits au chapitre 1er du titre Ier de la liste des produits et prestations remboursables prévue à l'article L. 165-1 du code de la sécurité sociale. JOURNAL OFFICIEL DE LA RÉPUBLIQUE FRANÇAISE. 27 février 2011
AFSSAPS. Direction de l'Evaluation des Dispositifs Médicaux, Département Surveillance du Marché, Unité Evaluation et Contrôle du Marché - DIV, Dossier suivi par Françoise Chevenne. CAHIER DES CHARGES RELATIF AUX NOTICES DES REACTIFS DOSANT L'HbA1c. Version du 10 janvier 2006
Agence Française de Sécurité Sanitaire des Aliments (AFSSA). Avis de l'Agence française de sécurité sanitaire des aliments relatif à l'actualisation des apports nutritionnels conseillés pour les acides gras. Saisine n° 2006-SA-0359. Mars 2010
ALFEDIAM PARAMEDICAL Recommandations de Bonnes pratiques. Alimentation du diabétique de type 2. Juin 2003
HAS Traitement médicamenteux du diabète de type 2 (actualisation). Novembre 2006.
American Diabetes Association (ADA). Physical activity/exercice and diabetes. Diabetes Care 2004, 27:S58-S62
Gold MR, Siegel JE, Russel LB, Weinstein MC. Cost-effectiveness in health and medicine. New-york : Oxford University Press, 1996.

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01955031     History of Changes
Other Study ID Numbers: 12 424 03, PREPS
Study First Received: August 22, 2013
Last Updated: August 18, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Toulouse:
Telemedicine
Telemonitoring
Education
Nutrition
Food behaviour
Weight
Physical activity
Glycaemia
Self-monitoring blood glucose

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 30, 2015