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Randomized Controlled Trial
. 2020 Dec;22(12):904-911.
doi: 10.1089/dia.2020.0021. Epub 2020 Oct 14.

DIABEO System Combining a Mobile App Software With and Without Telemonitoring Versus Standard Care: A Randomized Controlled Trial in Diabetes Patients Poorly Controlled with a Basal-Bolus Insulin Regimen

Sylvia Franc  1 , Hélène Hanaire  2 , Pierre-Yves Benhamou  3 , Pauline Schaepelynck  4 , Bogdan Catargi  5 , Anne Farret  6 , Pierre Fontaine  7 , Bruno Guerci  8 , Yves Reznik  9 , Nathalie Jeandidier  10 , Alfred Penfornis  2   11 , Sophie Borot  12 , Lucy Chaillous  13 , Pierre Serusclat  14 , Yacine Kherbachi  15 , Geneviève d'Orsay  16 , Bruno Detournay  17 , Pierre Simon  18 , Guillaume Charpentier  1
Affiliations
Randomized Controlled Trial

DIABEO System Combining a Mobile App Software With and Without Telemonitoring Versus Standard Care: A Randomized Controlled Trial in Diabetes Patients Poorly Controlled with a Basal-Bolus Insulin Regimen

Sylvia Franc et al. Diabetes Technol Ther. 2020 Dec.

Abstract

Background: The DIABEO® system (DS) is a telemedicine solution that combines a mobile app for patients with a web portal for health care providers. DS allows real-time monitoring of basal-bolus insulin therapy as well as therapeutic decision-making, integrating both basal and bolus dose calculation. Real-life studies have shown a very low rate of use of mobile health applications by patients. Therefore, we conducted a large randomized controlled trial study to investigate the efficacy of DS in conditions close to real life (TELESAGE study). Methods: TELESAGE was a multicenter, randomized, open study with three parallel arms: arm 1 (standard care), arm 2 (DIABEO alone), and arm 3 (DIABEO+telemonitoring by trained nurses). The primary outcome assessed the reduction in HbA1c levels after a 12-month follow-up. Results: Six hundred sixty-five patients were included in the study. Participants who used DIABEO once or more times a day (DIABEO users) showed a significant and meaningful reduction of HbA1c versus standard care after a 12-month follow-up: mean difference -0.41% for arm 2-arm 1 (P = 0.001) and -0.51% for arm 3-arm 1 (P ≤ 0.001). DIABEO users included 25.1% of participants in arm 2 and 37.6% in arm 3. In the intention-to-treat population, HbA1c changes and incidence of hypoglycemia were comparable between arms. Conclusions: A clinical and statistically significant reduction in HbA1c levels was found in those patients who used DIABEO at least once a day.

Keywords: Glycemic control; HbA1c; Hypoglycemia; Insulin therapy; Telemedicine.

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Conflict of interest statement

H.H. has received lecturer and scientific advisor fees from Abbott, Eli Lilly, Lifescan Novo Nordisk, and Sanofi-Aventis, as well as a research grant from Abbott, Lifescan, and Novo Nordisk. L.C. received personal compensation for board participation and speaking fees from Eli Lilly, Lifescan, Novo Nordisk, Roche Diagnostics, Medtronic, and Sanofi Aventis. S.F. has received personal compensation for board participation and speaking fees from Novo Nordisk, Roche Diagnostics, Lifescan, Sanofi, and Eli Lilly, as well as research support from MSD. She is the medical director and vice president of CERITD, which has developed DS in collaboration with Voluntis and she is the main investigator of the TELESAGE study, sponsored by Sanofi-Diabetes (Gentilly, France). P.Y.B. has received personal compensation for board participation and speaking fees from Abbott, Eli Lilly, Lifescan, Novo Nordisk, Roche Diagnostics, Medtronic, Sanofi Aventis, and BD. P.S. has received speaking fees from Sanofi, Abbott, and Lilly, and has participated on boards for Novo Nordisk and Sanofi. P.S. has received personal compensation for board participation and speaking fees from Johnson and Johnson, AstraZeneca, Eli Lilly, Medtronic, MSD, Novartis, Novo Nordisk, and Sanofi Aventis. B.C. has no conflicts of interest to declare concerning this study. Genevieve d'Orsay is Chief Medical Officer at Voluntis (Suresnes, France). P.F. has received personal compensation for board participation and speaking fees from Abbott, BD, Eli Lilly, MSD, Novartis, Novo Nordisk, and Sanofi. B.G. participated as an advisory panel/board member of Sanofi, Eli Lilly, Novo Nordisk, Novartis, GSK, MSD, Boehringer Ingelheim, AstraZeneca, Abbott, Medtronic, and Roche Diagnostics. He also participated as clinical investigator for Sanofi, Eli Lilly, Novo Nordisk, GSK, BMS, AstraZeneca, Medtronic, Abbott, Roche Diagnostics, MSD, Novartis, Janssen, and Boehringer Ingelheim, and received research support from Medtronic, Vitalaire, Sanofi, Eli Lilly, and Novo Nordisk. Y.R. has received personal compensation for board participation and speaking fees from Novo Nordisk, Sanofi, Eli Lilly, Medtronic, Takeda, Abbott, and Roche. N.J. received personal compensation for board participation and speaking fees from Eli Lilly, Novo Nordisk, Sanofi Aventis, and Roche. A.P. received personal compensation for board participation and speaking fees from Abbott, Ascencia, AstraZeneca, Eli Lilly, Medtronic, MSD, Novartis, Novo Nordisk, and Sanofi Aventis. S.B. has received personal compensation for board participation and speaking fees from Abbott, Eli Lilly, Novo Nordisk, Medtronic, and Sanofi Aventis. A.F. and P.S. have no conflicts of interest concerning this article. Y.K. is an employee of Sanofi. B.D. is employed by Cemka-Eval, a consulting team specializing in health economics, epidemiology, and outcomes research. He also received personal compensation for board participation and speaking fees from MSD, Novo Nordisk, Sanofi, Lilly, and Pfizer. P.S. received personal compensation for board participation and speaking fees from Sanofi Aventis. G.C. is employed by CERITD and received personal compensation for board participation, research funding, and speaking fees from Astra-Zeneca, Boehringer, Eli Lilly, Johnson & Johnson, MSD, Novo Nordisk, Sanofi Aventis, and Voluntis. Editorial support for R.P. Garay, Craven, Villemoisson-sur-Orge, France was funded by Sanofi.

Figures

FIG. 1.
FIG. 1.
Study design and patient disposition. *DIABEO® users, participants calculating prandial insulin doses with DIABEO at least one time per day during the month before the last HbA1c dosage.
FIG. 2.
FIG. 2.
Mean changes in HbA1c levels from baseline to a 12-month follow-up period were adjusted on baseline by using ANCOVA analysis. Differences in the adjusted mean changes in HbA1c values of the DIABEO arms versus the control arm were highly significant (arm 2—arm 1 = −0.41% [95% CI = −0.65 to −0.16], P = 0.001, and arm 3—arm 1 = −0.51% [95% CI = −0.73 to −0.30], P ≤ 0.001). CI, confidence interval.
FIG. 3.
FIG. 3.
Dose calculations during the first month of the study. For each decile (Xth), % values are given as the % cumulative doses from the first decile up to the Xth decile. In arm 2, a DIABEO use of at least once a day was found for 30%–40% of patients (cumulative doses from the first decile up to the seventh to eighth decile), whereas only 20%–30% of patients used DIABEO at least twice a day (first decile up to the eighth to ninth decile). In arm 3, a DIABEO use of at least once a day was found for 50%–60% of patients (first decile up to the eighth to ninth decile), whereas only 40%–50% of patients used DIABEO at least twice a day (first decile up to the eighth to ninth decile). Zero use rates (0%) were observed in a large number of participants.
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