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Randomized Controlled Trial
. 2019 Oct;21(10):2327-2332.
doi: 10.1111/dom.13806. Epub 2019 Jul 3.

Efficacy of two telemonitoring systems to improve glycaemic control during basal insulin initiation in patients with type 2 diabetes: The TeleDiab-2 randomized controlled trial

Sylvia Franc  1   2 , Michael Joubert  3 , Ahmed Daoudi  1 , Cédric Fagour  4 , Pierre-Yves Benhamou  5 , Michel Rodier  6 , Beatrix Boucherie  1 , Eric Benamo  7 , Pauline Schaepelynck  8 , Bruno Guerci  9 , Dured Dardari  1   2 , Sophie Borot  10 , Alfred Penfornis  2 , Geneviève D'Orsay  11 , Karine Mari  12 , Yves Reznik  3 , Caroline Randazzo  1 , Guillaume Charpentier  1   2 ; TeleDiab study group
Affiliations
Randomized Controlled Trial

Efficacy of two telemonitoring systems to improve glycaemic control during basal insulin initiation in patients with type 2 diabetes: The TeleDiab-2 randomized controlled trial

Sylvia Franc et al. Diabetes Obes Metab. 2019 Oct.

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.

Keywords: basal insulin; glycaemic control; insulin therapy; randomized trial; type 2 diabetes.

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Conflict of interest statement

S.F., A.D., C.R. and G.C. are employees of CERITD. G.O. is an employee of Voluntis. The other authors declare that they have no competing interests. CERITD funded the study. Novo Nordisk provided an unrestricted grant.

Figures

Figure 1
Figure 1
Overall study design A, and details of telephone consultations and visits, B. M1: optional face‐to‐face visit (control group, G1). M4 and M13: face‐to‐face visits for all patients. From W1 to W4: weekly phone consultations (for patients in the G2 and G3 groups). From W6 to W14: bimonthly phone consultations (for patients in the G2 and G3 groups). From M5 to M12: monthly phone consultations (for patients in the G3 group). IVRS, interactive voice response system
Figure 2
Figure 2
A, Changes from baseline in HbA1c levels at M4 and M13. HbA1c levels decreased more in patients from the G2 and G3 arms compared with the control arm, G1 (−0.53% and −0.51%, respectively; ***P < 0.002). B, Percentage of patients achieving target for glycaemic control (HbA1c <7.0%) at M4 and M13. At M4, the number of patients at target was significantly higher in the G2 and G3 arms as compared to the control arm (**P < 0.02). Control arm: G1: dark grey, G2: light grey and G3: pale cream. At M13, glycaemic control target was achieved in twice as many patients of G3 as in those of the control arm G1+G2 (P = 0.023). IVRS, interactive voice response system
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