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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

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Abstract

Aims

To compare iBGStar™ + 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.

Trial registration

The trial was registered at ClinicalTrials.gov (registration number NCT02073188).

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Acknowledgements

The authors thank the participating diabetes outpatient centers for their contribution.

Funding

The study was promoted by Sanofi SpA, Italy.

Author information

Authors and Affiliations

  1. AUSL Diabetes Unit Romagna, Ravenna, Italy

    Paolo Di Bartolo

  2. CORESEARCH - Center for Outcomes Research and Clinical Epidemiology, Via Tiziano Vecellio, 2, 65124, Pescara, Italy

    Antonio Nicolucci, Marco Scardapane & Maria Chiara Rossi

  3. Department of Pediatrics, Polytechnic University of Marche, Ancona, Italy

    Valentino Cherubini

  4. Department of Pediatrics, Second University of Naples, Naples, Italy

    Diario Iafusco

Authors
  1. Paolo Di Bartolo
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  2. Antonio Nicolucci
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  3. Valentino Cherubini
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  4. Diario Iafusco
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  5. Marco Scardapane
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  6. Maria Chiara Rossi
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Corresponding author

Correspondence to Maria Chiara Rossi.

Ethics declarations

Conflict of interest

Paolo Di Bartolo has been member of Advisory Panels of Novo Nordisk Inc., Eli Lilly and Company, Abbott, Novartis Corporation; he received Speaker’s Bureau from Eli Lilly and Company, Novo Nordisk Inc., Merck Sharp & Dohme, Boehringer Ingelheim Pharmaceuticals, Inc., Medtronic, Inc.,Ypsomed, Menarini Group, Abbott, Novartis Corporation, Roche Diagnostics, AstraZeneca Pharmaceuticals LP, Bayer HealthCare, Sanofi Pasteur SA. Maria Chiara Rossi has been member of an Advisory Panel of Novo Nordisk. Valentino Cherubini and Marco Scardapane have no conflict of interests. Dario Iafusco has been member of Advisory Panels of Eli Lilly and Company, Abbott and received Speaker’s Bureau from Eli Lilly and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Medtronic, Inc., Roche Diagnostics, Sanofi Pasteur SA. Antonio Nicolucci received Research Support from Sanofi Pasteur SA, Novo Nordisk Inc., Merck Sharp & Dohme, Bristol‐Myers Squibb Company, ForaCare, Artsana, Sanofi, Novo Nordisk, Dexcom.

Ethical standard

The study was conducted following accepted principles of ethical and professional conduct.

Human and animal rights

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008 (5).

Informed consent

Informed consent was obtained from all patients for being included in the study.

Additional information

Managed by Massimo Porta.

The trial was registered at ClinicalTrials.gov (registration number NCT02073188).

Electronic supplementary material

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Di Bartolo, P., Nicolucci, A., Cherubini, V. et al. 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. Acta Diabetol 54, 393–402 (2017). https://doi.org/10.1007/s00592-017-0963-4

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  • DOI: https://doi.org/10.1007/s00592-017-0963-4

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