Affiliation: | 1. CERITD (Centre for Studies and Research for the Intensification of Diabetes Treatment), Bioparc Genopole Campus, Evry, France;2. Diabetes Care Unit, Caen University Hospital, Caen, France;3. Department of Diabetology and Endocrinology, Fort-de-France University Hospital, Fort de France, France;4. Department of Diabetology, Endocrinology and Nutrition Diseases, Grenoble University Hospital, Grenoble, France;5. Department of Metabolic Diseases and Endocrinology, Nimes University Hospital, Nimes, France;6. Department of Endocrinology and Metabolic Diseases, Avignon University Hospital, Avignon, France;7. Department of Endocrinology, Diabetes and Metabolic Diseases, Marseille University Hospital, Marseille, France;8. Department of Endocrinology, Diabetes and Nutrition, Nancy University Hospital, Nancy, France;9. CERITD (Centre for Studies and Research for the Intensification of Diabetes Treatment), Bioparc Genopole Campus, Evry, France Department of Diabetes, Sud-Francilien Hospital, Corbeil-Essonnes, France;10. Department of Diabetology and Endocrinology, Besançon University Hospital, Besançon, France;11. Department of Diabetes, Sud-Francilien Hospital, Corbeil-Essonnes, France;12. Voluntis, Suresnes, Paris, France;13. Randomised Clinical Trials (RCTs') Department of Statistics, Lyon, France |
Abstract: | TeleDiab-2 was a 13-month randomized controlled trial evaluating the efficacy and safety of two telemonitoring systems to optimize basal insulin (BI) initiation in subjects with inadequately controlled type 2 diabetes (HbA1c, 7.5%-10%). A total of 191 participants (mean age 58.7 years, mean HbA1c 8.9%) were randomized into three groups: group 1(G1, standard care, n = 63), group 2 (G2, interactive voice response system, n = 64) and group 3 (G3, Diabeo-BI app software, n = 64). The two telemonitoring systems proposed daily adjustments of BI doses, in order to facilitate the achievement of fasting blood glucose (FBG) values targeted at ~100 mg/dL. At 4 months follow-up, HbA1c reduction was significantly higher in the telemonitoring groups (G2: −1.44% and G3: −1.48% vs. G1: −0.92%; P < 0.002). Moreover, target FBG was reached by twice as many patients in the telemonitoring groups as in the control group, and insulin doses were also titrated to higher levels. No severe hypoglycaemia was observed in the telemonitoring groups and mild hypoglycaemia frequency was similar in all groups. In conclusion, both telemonitoring systems improved glycaemic control to a similar extent, without increasing hypoglycaemic episodes. |