Type 2 DiabetesEDUC@DOMNCT01955031
Effectiveness and Cost-effectiveness of a Telemonitoring Program for Diabetic People at Home
A study testing telemonitoring in people with Type 2 Diabetes, run by University Hospital, Toulouse at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- telemonitoring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Jul 2019
- 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
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospitals of Toulouse (Rangueil and Salies-Du-Salat)
Toulouse, Midi-Pyrénées, 31059
About this study
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.
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.
- Conditions
- Type 2 Diabetes
- Being tested
- telemonitoring, Usual care
- Keywords
- Telemedicine, Telemonitoring, Education, Nutrition, Food behaviour, Weight, Physical activity, Glycaemia, Self-monitoring blood glucose
- Medical subject headings
- Diabetes Mellitus, Type 2, Body Weight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telemonitoringOther
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.
Usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring | Experimental | Patient with type 2 diabetes randomized in telemonitoring group have a telemonitoring device with educational Tools at their home Receives: Other: telemonitoring |
| Usual care | Sham comparator | patient randomized in this group have a usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: HbA1c will be measured at Day 0, month 1, month 3, month 6, month 9 and month 12
Secondary outcomes (17)
Assessment efficacy of our program by the measure of HbA1C will
Measured: At month 15, month 18, month 21 and month 24
Questionnaires will be given to patients to assess the improvement of nutritional knowledge
Measured: At day 0 and month 24
Food inquiries will be given to patients to assess the improvement of eating habits
Measured: At day 0 and month 24
Questionnaires will be given to patients to assess the physical activity practice
Measured: At day 0 and month 24
Waist circumference will be measured to assess the body composition, BMI (Body Mass Index),
Measured: At day 0 and month 24
The self-monitoring blood glucose books will be copied to assess mean of blood glycaemia
Measured: At day 0, month 12 and month 24
A blood sample will be collected to assess lipid status
Measured: At day 0 and month 24
Two questionnaires will be given to patients to assess quality of life of patients
Measured: At day 0 and month 24
A cost-effectiveness ratio and a markov modelisation will be realized to assess the economic aspects
Measured: At month 24
For the telemonitoring arm, assessment of food behavior through meals registered with the Nutri-Educ software
Measured: Everytime patients use the software from Day 0 to month 24
For the telemonitoring arm, assessment of nutritional knowledge through rate of good choices playing games of Nutri-Kiosk software
Measured: Everytime patients use the software from Day0 to month 24
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)
Measured: Every time patients use the software and the pedometer from day 0 to month 24
For the telemonitoring arm, measure of weight, fat rate and lean rate collected with the balance
Measured: Everytime patients use the balance from day 0 to month 24
For the telemonitoring arm, means of glycaemia collected with the self-monitoring blood glucose device
Measured: Everytime patients use the blood glucose device from day 0 to month 24
For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the patients with the number and time of connections and a questionnaire
Measured: At month 24
For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the health professionals with the number and time of connections
Measured: At month 24
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
Measured: At month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2016
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (60)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Christine TURNIN, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955031
- Sponsor's protocol ID
- 12 424 03
- Other IDs
- PREPS
- Acronym
- EDUC@DOM
- Status last verified
- Aug 2021
- First submitted
- 22 Aug 2013
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
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
Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
PubMed 8366922Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.
PubMed 9742976HAS (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
Trento M, Gamba S, Gentile L, Grassi G, Miselli V, Morone G, Passera P, Tonutti L, Tomalino M, Bondonio P, Cavallo F, Porta M; ROMEO Investigators. Rethink Organization to iMprove Education and Outcomes (ROMEO): a multicenter randomized trial of lifestyle intervention by group care to manage type 2 diabetes. Diabetes Care. 2010 Apr;33(4):745-7. doi: 10.2337/dc09-2024. Epub 2010 Jan 26.
PubMed 20103547Welschen LM, Bloemendal E, Nijpels G, Dekker JM, Heine RJ, Stalman WA, Bouter LM. Self-monitoring of blood glucose in patients with type 2 diabetes who are not using insulin: a systematic review. Diabetes Care. 2005 Jun;28(6):1510-7. doi: 10.2337/diacare.28.6.1510. No abstract available.
PubMed 15920083Norris SL, Engelgau MM, Narayan KM. Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care. 2001 Mar;24(3):561-87. doi: 10.2337/diacare.24.3.561.
PubMed 11289485INPES (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
Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K. Home telehealth for diabetes management: a systematic review and meta-analysis. Diabetes Obes Metab. 2009 Oct;11(10):913-30. doi: 10.1111/j.1463-1326.2009.01057.x. Epub 2009 Jun 16.
PubMed 19531058McMahon GT, Gomes HE, Hickson Hohne S, Hu TM, Levine BA, Conlin PR. Web-based care management in patients with poorly controlled diabetes. Diabetes Care. 2005 Jul;28(7):1624-9. doi: 10.2337/diacare.28.7.1624.
PubMed 15983311Quinn CC, Clough SS, Minor JM, Lender D, Okafor MC, Gruber-Baldini A. WellDoc mobile diabetes management randomized controlled trial: change in clinical and behavioral outcomes and patient and physician satisfaction. Diabetes Technol Ther. 2008 Jun;10(3):160-8. doi: 10.1089/dia.2008.0283.
PubMed 18473689Shea S, Weinstock RS, Teresi JA, Palmas W, Starren J, Cimino JJ, Lai AM, Field L, Morin PC, Goland R, Izquierdo RE, Ebner S, Silver S, Petkova E, Kong J, Eimicke JP; IDEATel Consortium. A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study. J Am Med Inform Assoc. 2009 Jul-Aug;16(4):446-56. doi: 10.1197/jamia.M3157. Epub 2009 Apr 23.
PubMed 19390093
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01955031
- Acronym / sponsor ID
- EDUC@DOM / 12 424 03
- Conditions
- Type 2 Diabetes
- Keywords
- Telemedicine, Telemonitoring, Education, Nutrition, Food behaviour, Weight, Physical activity, Glycaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 7 Oct 2013 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | Experimental | Other: telemonitoringPatient with type 2 diabetes randomized in telemonitoring group have a telemonitoring device with educational Tools at their home |
| Usual care | Sham comparator | Other: Usual carepatient randomized in this group have a usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| telemonitoringA 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. | Other | Telemonitoring |
| Usual carePatients 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. | Other | Usual care |
Primary outcome
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
17 secondary outcomes
Assessment efficacy of our program by the measure of HbA1C will
Time frame: At month 15, month 18, month 21 and month 24
Questionnaires will be given to patients to assess the improvement of nutritional knowledge
Time frame: At day 0 and month 24
Food inquiries will be given to patients to assess the improvement of eating habits
Time frame: At day 0 and month 24
Questionnaires will be given to patients to assess the physical activity practice
Time frame: At day 0 and month 24
Waist circumference will be measured to assess the body composition, BMI (Body Mass Index),
Time frame: At day 0 and month 24
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
A blood sample will be collected to assess lipid status
Time frame: At day 0 and month 24
Two questionnaires will be given to patients to assess quality of life of patients
Time frame: At day 0 and month 24
A cost-effectiveness ratio and a markov modelisation will be realized to assess the economic aspects
Time frame: At month 24
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
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
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
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
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
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
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
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
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 31 Aug 2021.
- BackgroundInVS (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
- Background: PubMed 8366922Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
- Background: PubMed 9742976Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.
- BackgroundHAS (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.
- BackgroundHAS (Haute Autorité de Santé). Rapport d'orientation - Développement de la prescription de thérapeutiques non médicamenteuses validées - Avril 2011
- Background: PubMed 20103547Trento M, Gamba S, Gentile L, Grassi G, Miselli V, Morone G, Passera P, Tonutti L, Tomalino M, Bondonio P, Cavallo F, Porta M; ROMEO Investigators. Rethink Organization to iMprove Education and Outcomes (ROMEO): a multicenter randomized trial of lifestyle intervention by group care to manage type 2 diabetes. Diabetes Care. 2010 Apr;33(4):745-7. doi: 10.2337/dc09-2024. Epub 2010 Jan 26.
- Background: PubMed 15920083Welschen LM, Bloemendal E, Nijpels G, Dekker JM, Heine RJ, Stalman WA, Bouter LM. Self-monitoring of blood glucose in patients with type 2 diabetes who are not using insulin: a systematic review. Diabetes Care. 2005 Jun;28(6):1510-7. doi: 10.2337/diacare.28.6.1510. No abstract available.
- Background: PubMed 11289485Norris SL, Engelgau MM, Narayan KM. Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care. 2001 Mar;24(3):561-87. doi: 10.2337/diacare.24.3.561.
- BackgroundINPES (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
- BackgroundHAS (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
- BackgroundMINISTÈRE 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
- Background: PubMed 19531058Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K. Home telehealth for diabetes management: a systematic review and meta-analysis. Diabetes Obes Metab. 2009 Oct;11(10):913-30. doi: 10.1111/j.1463-1326.2009.01057.x. Epub 2009 Jun 16.
- Simon P, Acker D. La place de la telemedicine dans l'organisation des soins. Rapport :2008Link provided by the sponsor.
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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.
Marie-Christine TURNIN, MD principal investigator
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telemonitoring in people with Type 2 Diabetes, run by University Hospital, Toulouse at 1 site 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 14 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 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
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). 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 NCT01955031, which also lists 60 linked publications.
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 31 Aug 2021; AzTrials last refreshed its copy on 3 Nov 2026.