title: 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.
abstract: To compare iBGStar™ + DMApp (experimental meter + telemedicine system) (iBGStar) with a traditional glucose meter (Control) in type 1 diabetes adolescents/young adults.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  The trial was registered at ClinicalTrials.gov (registration number NCT02073188).
authors.affiliation: AUSL Diabetes Unit Romagna, Ravenna, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Di Bartolo
authors.affiliation: CORESEARCH - Center for Outcomes Research and Clinical Epidemiology, Via Tiziano Vecellio, 2, 65124, Pescara, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Nicolucci
authors.affiliation: Department of Pediatrics, Polytechnic University of Marche, Ancona, Italy.
authors.forename: Valentino
authors.initials: V
authors.lastname: Cherubini
authors.affiliation: Department of Pediatrics, Second University of Naples, Naples, Italy.
authors.forename: Diario
authors.initials: D
authors.lastname: Iafusco
authors.affiliation: CORESEARCH - Center for Outcomes Research and Clinical Epidemiology, Via Tiziano Vecellio, 2, 65124, Pescara, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Scardapane
authors.affiliation: CORESEARCH - Center for Outcomes Research and Clinical Epidemiology, Via Tiziano Vecellio, 2, 65124, Pescara, Italy. rossi@coresearch.it.
authors.forename: Maria Chiara
authors.initials: MC
authors.lastname: Rossi
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D055815:Young Adult; D000367:Age Factors; D015374:Biosensing Techniques / Q000295:instrumentation / Q000639:trends; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000379:methods / Q000639:trends; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000150:complications / Q000453:epidemiology / Q000628:therapy; D006442:Glycated Hemoglobin / Q000032:analysis; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D007328:Insulin / Q000008:administration & dosage; D010349:Patient Compliance / Q000706:statistics & numerical data; D011788:Quality of Life; D017216:Telemedicine / Q000295:instrumentation / Q000639:trends
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: Compliance; Self-monitoring blood glucose; Telemedicine; Type 1 diabetes