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

NCT01955031 | Completed DMC

• 2 other identifiers: 12 424 03PREPS
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

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

Keywords

Telemedicine; Telemonitoring; Education; Nutrition; Food behaviour; Weight; Physical activity; Glycaemia; Self-monitoring blood glucose

Outcome Measures

Primary Outcomes (1)

• 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

  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

  At month 15, month 18, month 21 and month 24

• Questionnaires will be given to patients to assess the improvement of nutritional knowledge

  At day 0 and month 24

• Food inquiries will be given to patients to assess the improvement of eating habits

  At day 0 and month 24

• Questionnaires will be given to patients to assess the physical activity practice

  At day 0 and month 24

• Waist circumference will be measured to assess the body composition, BMI (Body Mass Index),

  At day 0 and month 24

Study Arms (2)

Telemonitoring

EXPERIMENTAL

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

Other: telemonitoring

Usual care

SHAM COMPARATOR

patient randomized in this group have a usual care

Other: Usual care

Interventions

telemonitoring 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.

Telemonitoring

Usual care 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.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• A person under legal protection
• Subject living in institutions
• Desire for pregnancy, pregnancy or breastfeeding

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

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

Toulouse, Midi-Pyrénées, 31059, France

Location

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• Mounie M, Costa N, Gourdy P, Latorre C, Schirr-Bonnans S, Lagarrigue JM, Roussel H, Martini J, Buisson JC, Chauchard MC, Delaunay J, Taoui S, Poncet MF, Cosma V, Lablanche S, Coustols-Valat M, Chaillous L, Thivolet C, Sanz C, Penfornis A, Lepage B, Colineaux H, Hanaire H, Molinier L, Turnin MC; Educ@dom Study Group. Cost-Effectiveness Evaluation of a Remote Monitoring Programme Including Lifestyle Education Software in Type 2 Diabetes: Results of the Educ@dom Study. Diabetes Ther. 2022 Apr;13(4):693-708. doi: 10.1007/s13300-022-01207-1. Epub 2022 Feb 8.

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Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Body Weight; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Marie-Christine TURNIN, MD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: October 7, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2019
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

FR (1)