Young patients with type 1 diabetes poorly controlled and poorly compliant with self-monitoring of blood glucose: can technology help? Results of the i-NewTrend randomized clinical trial

Aims To compare iBGStar(TM) + DMApp (experimental meter + telemedicine system) (iBGStar) with a traditional glucose meter (Control) in type 1 diabetes adolescents/ young adults. Methods i-NewTrend was a multicenter, open-label, randomized trial involving subjects aged 14-24 years, on basal-bolus insulin, HbA1c >= 8.0%, and poorly compliant with SMBG (i. e.,< 30% of the recommended frequency). Primary end points were change in HbA1c and achievement of compliance with SMBG (>= 30% of the recommended frequency) after 6 months. Quality of life was also evaluated. A post-trial observational phase was conducted, where both groups used the experimental device. Results Of 182 randomized patients (51.1% male; age 17.7 +/- 3.0 years; diabetes duration 8.8 +/- 4.7 years; HbA1c levels 10.0% +/- 1.4), 92 were allocated to iBGStar and 90 to Control; 6.5% in iBGStar and 8.9% in Control dropped-out. After 6 months, HbA1c changes (+/- SE) were -0.44% +/- 0.13 in iBGStar and -0.32% +/- 0.13 in Control (p = 0.51). In the post-trial phase, HbA1c changes from 6 months (+/- SE) were -0.07% +/- 0.14 in iBGStar and -0.31% +/- 0.14 in Control (p = 0.24). Compliance end point was reached by 53.6% in iBGStar and 55.0% in Control (p = 0.86). Mean daily SMBG measurements increased from 1.1 to 2.3 in both groups without worsening quality of life. Compliant subjects showed a greater reduction in HbA1c levels (-0.60% +/- 0.23 in iBGStar; -0.41% +/- 0.21 in Control; p = 0.31). Within iBGStar group, telemedicine users (38.0%) reduced HbA1c by -0.58 +/- 0.18. Conclusions iBGStar was not superior to the traditional meter. Irrespective of the strategy, increasing from 1 to 2 SMBG tests/day was associated with HbA1c reduction in both groups, without pharmacologic interventions. Identifying new technologies effective and acceptable to patients is an option to improve adherence to diabetes care.