Impact of a Remote Monitoring Programme Including Lifestyle Education Software in Type 2 Diabetes: Results of the Educ@dom Randomised Multicentre Study

Marie-Christine Turnin, Pierre Gourdy, Jacques Martini, Jean-Christophe Buisson, Marie-Christine Chauchard, Jacqueline Delaunay, Solène Schirr-Bonnans, Soumia Taoui, Marie-France Poncet, Valeria Cosma, Sandrine Lablanche, Magali Coustols-Valat, Lucie Chaillous, Charles Thivolet, Caroline Sanz, Alfred Penfornis, Benoît Lepage, Hélène Colineaux, Michaël Mounié, Nadège Costa, Laurent Molinier, Hélène Hanaire, Educ@dom Study Group, Marie-Christine Turnin, Pierre Gourdy, Jacques Martini, Jean-Christophe Buisson, Marie-Christine Chauchard, Jacqueline Delaunay, Solène Schirr-Bonnans, Soumia Taoui, Marie-France Poncet, Valeria Cosma, Sandrine Lablanche, Magali Coustols-Valat, Lucie Chaillous, Charles Thivolet, Caroline Sanz, Alfred Penfornis, Benoît Lepage, Hélène Colineaux, Michaël Mounié, Nadège Costa, Laurent Molinier, Hélène Hanaire, Educ@dom Study Group

Abstract

Introduction: Telemonitoring in type 2 diabetes (T2D) is mainly based on glucose monitoring. A new type of connected device which routinely gathers data on weight, physical activity and food intake could improve patients' diabetes control. The main aim of this study was to assess the efficacy of an at-home interventional programme incorporating such devices and lifestyle education software on diabetes control, i.e., change in HbA1c, compared to standard care.

Methods: This multicentre study randomly assigned 282 people with T2D to either a telemonitoring group (TMG) or a control group (CG) for a 1-year intervention period. While routine follow-up was maintained in the CG, TMG subjects were provided with interactive lifestyle educational software (with artificial intelligence algorithms) and connected objects (blood glucose meters, scales and actimeters) for use in their own homes and were remotely monitored by their diabetologists. Changes in HbA1c were compared between groups using a mixed linear model.

Results: The mean HbA1c dropped from 7.8 ± 0.8% (62 mmol/mol) to 7.4 ± 1.0% (57 mmol/mol) in the TMG and from 7.8 ± 0.8% (62 mmol/mol) to 7.6 ± 1.0% (60 mmol/mol) in the CG, resulting in an intergroup difference of - 0.16 (p = 0.06) in favour of TMG, after adjustment for confounding factors. Within TMG, the decrease in HbA1c was greater in frequent users: - 0.23% (p = 0.03) in the case of connections to telemonitoring synthesis above the median and - 0.21% (p = 0.05) in the case of connections to tele-education software above the median compared to the CG. Significant weight loss was observed in the TMG but only in women (p = 0.01).

Findings: The EDUC@DOM telemonitoring and tele-education device did not highlight a significant decrease in HbA1c levels compared to routine management although a slight, albeit significant improvement in glycaemic control was observed in the frequent user subgroup as well as significant weight loss but only in women. A high level of satisfaction with the connected device was recorded amongst all participants.

Trial registration: This trial was registered in the Clinical Trials Database on September 27, 2013, under no. NCT01955031 and bears ID-RCB number 2013-A00391-44.

Keywords: Glucose control; Health-related objects; Lifestyle management; Tele-education; Telemonitoring; Type 2 diabetes.

Figures

Fig. 1
Fig. 1
Flow chart
Fig. 2
Fig. 2
Mean HbA1c observed (at baseline) or predicted according to time of follow-up
Fig. 3
Fig. 3
Correlations between frequency of use and changes in HbA1c and BMI. With: solid lines for non-parametric (Lowess) models and dashed lines for linear models. Since the correlations are graphically linear, the following are presented: ρ, Pearson correlation coefficient, with confidence intervals estimated by bootstrapping (1000 replications) and p value by the Pearson correlation coefficient test.
Fig. 4
Fig. 4
Evaluation of device use by telemonitored patients

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