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International Journal of Clinical Pharmacy

, Volume 37, Issue 5, pp 790–798 | Cite as

Pharmaceutical care of adolescents with diabetes mellitus type 1: the DIADEMA study, a randomized controlled trial

  • Emina ObarcaninEmail author
  • Manfred Krüger
  • Petra Müller
  • Verena Nemitz
  • Holger Schwender
  • Snijezana Hasanbegovic
  • Sena Kalajdzisalihovic
  • Stephanie Läer
Research Article

Abstract

Background Physiological and psychological changes during puberty and a low adherence to complex treatment regimens often result in poor glycemic control in adolescents with type 1 diabetes mellitus (T1DM). The benefit of pharmaceutical care in adults with diabetes mellitus type 2 has been explored; however, evidence in adolescents with T1DM is scarce. Objective To evaluate the impact of pharmaceutical care in adolescents with T1DM provided by pharmacists, in collaboration with physicians and diabetes educators on important clinical outcomes (e.g., HbA1c and severe hypoglycemia) Setting: At the outpatient Helios Paediatric Clinic and at the 12 regular community pharmacies of the study patients with 14 pharmacists in the Krefeld area, Germany, and at the University Pediatric Clinic with one clinical pharmacist on-site in Sarajevo, Bosnia-Herzegovina. Methods A randomized, controlled, prospective, multicenter study in 68 adolescents with T1DM. The intervention group received monthly structured pharmaceutical care visits delivered by pharmacists plus supplementary visits and phone calls on an as needed basis, for 6 months. The control group received usual diabetic care. Data were collected at baseline and after 3 and 6 months. Main outcome measures: The between-group difference in the change from baseline in glycosylated hemoglobin (HbA1c) and the number of severe hypoglycemic events in both groups. Results The improvement from baseline in HbA1c was significantly greater in the intervention group than in the control group after 6 months (change from baseline −0.54 vs. +0.32 %, p = 0.0075), even after adjustment for country-specific variables (p = 0.0078). However, the effect was more pronounced after only 3 months (−1.09 vs. +0.23 %, p = 0.00002). There was no significant between-group difference in the number of severe hypoglycemia events. (p = 0.1276). Conclusion This study suggests that multidisciplinary PhC may add value in the management of T1DM in adolescents with inadequate glycemic control. However, the optimal methods on how to achieve sustained, long-term improvements in this challenging population require further study.

Keywords

Adolescents Bosnia-Herzegovina Germany Glycemic control Pharmaceutical care Pharmacists Type 1 diabetes mellitus 

Notes

Acknowledgments

The authors thank the patients. They also thank the participating pharmacists (in alphabetical order): Henrich Dieter Backes, Zora Bahser, Hans-Dieter Brink, Dieter Conze, Kathrin Furth, Klaus Dieter von Laguna, Anja Müller, Norbert Müller, Anne Rhein, Mara Scholz, Friederike Sieben, Ralf Weckop, Katja Weissenborn, and the pediatric clinic directors: Prof. Dr. med. Tim Niehues and Prof. Dr. med. Senka Mesihovic-Dinarevic. We are indebted to K. A. Lyseng-Williamson and L.Yang for editorial assistance.

Funding

Emina Obarcanin was financially supported by the Deutsche Akademische Auslandsdienst (DAAD), the Lesmüller Stiftung, and the Heinrich-Heine University, Düsseldorf, Germany. The study was partially supported by the Lesmüller Stiftung.

Conflicts of interest

The authors have no conflicts of interest.

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Copyright information

© Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2015

Authors and Affiliations

  • Emina Obarcanin
    • 1
    Email author
  • Manfred Krüger
    • 2
  • Petra Müller
    • 3
  • Verena Nemitz
    • 3
  • Holger Schwender
    • 4
  • Snijezana Hasanbegovic
    • 5
  • Sena Kalajdzisalihovic
    • 5
  • Stephanie Läer
    • 1
  1. 1.Department of Clinical Pharmacy and TherapeuticsHeinrich Heine UniversityDüsseldorfGermany
  2. 2.Linner PharmacyKrefeldGermany
  3. 3.Helios Pediatric ClinicKrefeldGermany
  4. 4.Mathematical InstituteHeinrich Heine UniversityDüsseldorfGermany
  5. 5.Pediatric ClinicUniversity Clinical Center SarajevoSarajevoBosnia-Herzegovina

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