Telecare Provides comparable efficacy to conventional self-monitored blood glucose in patients with type 2 diabetes titrating one injection of insulin glulisine-the ELEONOR study.
BACKGROUND
We compared telecare and conventional self-monitored blood glucose (SMBG) programs for titrating the addition of one bolus injection of insulin glulisine in patients with type 2 diabetes uncontrolled on oral hypoglycemic agents for ≥3 months who were first titrated with basal insulin glargine.


METHODS
This randomized, multicenter, parallel-group study included 241 patients (mean screening glycosylated hemoglobin [HbA(1c)], 8.8% [73 mmol/mol]). In the run-in phase, any antidiabetes medication, except for metformin, was discontinued. Metformin was then up-titrated to 2 g/day (1 g twice daily) until study completion. Following run-in, all patients started glargine for 8-16 weeks, targeting fasting plasma glucose (FPG) ≤5.6 mmol/L using conventional SMBG. Patients with FPG ≤7 mmol/L added a glulisine dose at the meal with the highest postprandial plasma glucose excursion, titrated to target 2-h postprandial plasma glucose level <7.8 mmol/L using telecare or SMBG for 24 weeks. Patients with FPG >7 mmol/L at week 16 were withdrawn from the study.


RESULTS
After glargine titration, 224 patients achieved FPG ≤7 mmol/L, without any difference between telecare and SBMG groups (mean±SD, 6.2±0.8 vs. 6.0±0. 9 mmol/L, respectively). HbA(1c) levels were lower following titration and were similar for telecare and SMBG (7.9±0.9% vs. 7.8±0.9% [63 vs. 62 mmol/mol], respectively). Adding glulisine further reduced HbA(1c) in both groups (-0.7% vs. -0.7%); 45.2% and 54.8% (P=0.14), respectively, of patients achieved HbA(1c) ≤7.0% (≤53 mmol/mol). Weight change and hypoglycemia were similar between groups.


CONCLUSIONS
Patients adding one dose of glulisine at the meal with the highest postprandial plasma glucose excursion to titrated basal glargine achieved comparable improvements in glycemic control irrespective of traditional or telecare blood glucose monitoring.
Department of Endocrinology and Metabolism, University of Pisa, Pisa, Italy. stefano.delprato@med.unipi.it
Stefano
S
Del Prato
Antonio
A
Nicolucci
Augusto C
AC
Lovagnini-Scher
Salvatore
S
Turco
Sergio
S
Leotta
Giacomo
G
Vespasiani
D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000379:methods; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005215:Fasting; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007267:Injections / Q000379:methods*; D007328:Insulin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008297:Male; D008687:Metformin / Q000008:administration & dosage; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000295:instrumentation / Q000379:methods*; D019518:Postprandial Period; D017216:Telemedicine / Q000295:instrumentation / Q000379:methods*; D016896:Treatment Outcome
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D008687:Metformin; C479079:insulin glulisine