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

August 25, 2021 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

282

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Midi-Pyrénées
      • Toulouse, Midi-Pyrénées, France, 31059
        • University Hospitals of Toulouse (Rangueil and Salies-Du-Salat)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telemonitoring
Patient with type 2 diabetes randomized in telemonitoring group have a telemonitoring device with educational Tools at their home
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
patient randomized in this group have a 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
HbA1c will be measured at Day 0, month 1, month 3, month 6, month 9 and month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment efficacy of our program by the measure of HbA1C will
Time Frame: At month 15, month 18, month 21 and month 24
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
At month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Marie-Christine TURNIN, MD, University Hospital of Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

August 22, 2013

First Submitted That Met QC Criteria

September 27, 2013

First Posted (Estimate)

October 7, 2013

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12 424 03
  • PREPS (Other Identifier: CHU de Toulouse)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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