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

Toulouse University Hospital

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Other: telemonitoring

Other: Usual care

Study type

Interventional

Funder types

Other

Identifiers

NCT01955031

PREPS (Other Identifier)

12 424 03

Details and patient eligibility

About

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.

Enrollment

282 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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