Effectiveness and Cost-effectiveness of a Telemonitoring Program for Diabetic People at Home

NCT ID: NCT01955031

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2019-07-31

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Telemonitoring

Patient with type 2 diabetes randomized in telemonitoring group have a telemonitoring device with educational Tools at their home

Group Type: EXPERIMENTAL

telemonitoring

Intervention Type: OTHER

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 care

patient randomized in this group have a usual care

Group Type: SHAM_COMPARATOR

Usual care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Christine TURNIN, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Toulouse

Locations

University Hospitals of Toulouse (Rangueil and Salies-Du-Salat)

Toulouse, Midi-Pyrénées, France

Countries

France

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Related Links

http://www.sante.gouv.fr/IMG/pdf/Rapport_final_Telemedecine.pdf

Simon P, Acker D. La place de la telemedicine dans l'organisation des soins. Rapport :2008

Other Identifiers

PREPS

Identifier Type: OTHER

Identifier Source: secondary_id

12 424 03

Identifier Type: -

Identifier Source: org_study_id