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

N/ACompletedNCT01955031

University Hospital, Toulouse282 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

282

Conditions

Type 2 Diabetes

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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