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Diabetology International

, Volume 9, Issue 2, pp 84–99 | Cite as

The current status of treatment-related severe hypoglycemia in Japanese patients with diabetes mellitus: a report from the committee on a survey of severe hypoglycemia in the Japan Diabetes Society

  • Mitsuyoshi Namba
  • Toshio Iwakura
  • Rimei Nishimura
  • Kohei Akazawa
  • Munehide Matsuhisa
  • Yoshihito Atsumi
  • Jo Satoh
  • Toshimasa Yamauchi
  • on behalf of the Japan Diabetes Society (JDS) Committee for Surveys on Severe Hypoglycemia
Report of the committee
  • 218 Downloads

Abstract

Despite great strides in pharmacotherapy for diabetes, there is increasing concern over the risk of hypoglycemia in patients with diabetes receiving pharmacotherapy as they become increasingly older. This has prompted the Japan Diabetes Society (JDS) to initiate a survey on the current status of severe hypoglycemia in clinical settings. In July 2015, following approval from the JDS Scientific Survey/Research Ethics Committee, the JDS extended an invitation to executive educators, who represented a total of 631 health-care facilities accredited by the JDS for diabetes education, to participate in the proposed survey. Of these, those who expressed their willingness to participate in the survey were sent an application form required for obtaining ethical approval at these health-care facilities and were then asked, following approval, to enter relevant clinical data on an unlinked, anonymous basis in a Web-based registry. The current survey was fully funded by the JDS Scientific Survey/Research Committee. A case registry (clinical case database) was launched after facility-specific information (healthcare facility database) was collected from all participating facilities and after informed consent was obtained from all participating patients. With severe hypoglycemia defined as the “presence of hypoglycemic symptoms requiring assistance from another person to treat and preferably venous plasma glucose levels at onset/diagnosis of disease or at presentation clearly less than 60 mg/dL (capillary whole blood glucose, less than 50 mg/dL)”, the current survey was conducted between April 1, 2014 and March 31, 2015, during which facility-specific information was collected from a total of 193 facilities with a total of 798 case reports collected from 113 facilities. Of the 193 respondent facilities, 149 reported having an emergency department as well, with the median number of patients who required emergency transportation services to reach these facilities totaling 4962 annually, of which those with severe hypoglycemia accounted for 0.34% (17). The respondent facilities accommodated a total of 2237 patients with severe hypoglycemia annually, with the number of patients thus accommodated being 6.5 patients per site. A total of 1171 patients were admitted for severe hypoglycemia, with the number of patients thus admitted being 4.0 per site, who accounted for 52.3% of all patients visiting annually for severe hypoglycemia. A review of the 798 case reports collected during the survey revealed that 240, 480, and 78 patients had type 1 diabetes, type 2 diabetes, and other types of diabetes, respectively; those with type 2 diabetes were shown to be significantly older [median (interquartile range), 77.0 (68.0–83.0)] than those with type 1 diabetes [54.0 (41.0–67.0)] (P < 0.001); and the BMI was shown to be significantly higher for those with type 2 diabetes [22.0 (19.5–24.8) kg/m2] than for those with type 1 diabetes [21.3 (18.9–24.0) kg/m2] (P = 0.003). It was also found that the median estimated glomerular filtration rate (eGFR) was significantly lower among those with type 2 diabetes [50.6 mL (31.8–71.1)/min/1.73 m2] than among those with type 1 diabetes [73.3 (53.5–91.1) mL/min/1.73 m2] (P < 0.001). Again, the median HbA1c value at onset of severe hypoglycemia was shown to be 7.0 (6.3–8.1)% among all patients examined, 7.5 (6.9–8.6)% among those with type 1 diabetes, and 6.8 (6.1–7.6)% among those with type 2 diabetes, with the HbA1c value at onset of hypoglycemia being significantly lower among those with type 2 diabetes (P < 0.001). Antecedent symptoms of severe hypoglycemia were shown to be present, absent, and unknown in 35.5, 35.6, and 28.9% of all patients, respectively, with the incidence of symptomatic hypoglycemia being significantly lower among those with type 1 diabetes (41.0%) than among those with type 2 diabetes (56.9%). The antidiabetic agents used in those with type 2 diabetes were insulin preparations (292 patients including 29 receiving concomitant sulfonylureas [SUs]) (60.8%), SUs (159 insulin-naïve patients) (33.1%), and no insulin preparations or SUs (29 patients) (6.0%). Of the 798 patients surveyed, 296 patients (37.2%) were shown to have required emergency transportation services for severe hypoglycemia before. Thus, the survey revealed, for the first time, the current status of treatment-related severe hypoglycemia in Japan and clearly highlights the acute need for implementing preventive measures against hypoglycemia, not only through education on hypoglycemia but also through optimization of antidiabetic therapy for those at high risk of severe hypoglycemia or those with a history of severe hypoglycemia.

Keywords

Severe hypoglycemia Insulin Sulfonylureas 

Notes

Acknowledgements

The authors would like to thank Ms. Mari Watanabe, Department of Medical Informatics, Niigata University Medical & Dental Hospital, for her assistance with in-depth analysis of the survey data. The authors also enormously thank Mr. Masayasu Yamada, a legal advisor for the JDS, for his expert advice and counsel on the ethical aspects of the survey and Ms. Maki Sato and Mr. Hitomi Shibasaki, Secretariat of the JDS, for their superb administrative assistance throughout the survey. The authors’ sincere thanks are also due to all physicians at the JDS-accredited educational facilities mentioned in Supplementary Table for their generous help in sharing their valuable data.

Compliance with ethical standards

Conflicts of interests

Mitsuyoshi Namba: speaker fees (Sanwa Kagaku Kenkyuusho Co., Ltd, Sanofi K. K., Novo Nordisk Co., Ltd., AstraZeneca, Novartis Pharma K.K., Nippon Eli Lilly Japan K.K., Mitsubishi Tanabe Corporation, and Kowa Pharmaceutical Co., Ltd.); clinical research grants (funding for clinical trials, clinical studies, contracted research, and collaborative research) (Arkray Inc.); endowed scholarships/donations (Astellas Pharm Inc., Novartis Pharma K.K., Sanwa Kagaku Kenkyuusho Co., Ltd, Kyowa Hakko Co., Ltd., Kowa Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Teijin Pharma Co., Ltd., Mitsubishi Tanabe Corporation, Nippon Boehringer Co., Ltd., Takeda Pharmaceutical Co., Ltd., Sanofi K. K., Sumitomo Dainippon Pharma Co., Ltd., AstraZeneca, and Pfizer Japan Inc.); endowed lectures (Mitsubishi Tanabe Corporation, Nippon Eli Lilly Japan K.K., and Sanwa Kagaku Kenkyuusho Co.). Toshio Iwakura: none. Rimei Nishimura: speaker fees (Sanofi K. K., Medtronic Japan Co., Ltd., Nippon Boehringer Co., Ltd., Takeda Pharmaceutical Co., Ltd., Nippon Eli Lilly Japan K.K., Novartis Pharma K.K., and Astellas Pharm Inc.). Kohei Akazawa: endowed scholarships/donations (Japanese Foundation for Multidisciplinary Treatment for Cancer, Medical Informatics Study Group, and Japan Diabetes Society). Munehide Matsuhisa: speaker fees (Sanofi K. K., Novartis Pharma K.K., Novo Nordisk Co., Ltd., Mitsubishi Tanabe Corporation, Astellas Pharm Inc., Takeda Pharmaceutical Co., Ltd., Nippon Eli Lilly Japan K.K.); clinical research grants (funding for clinical trials, clinical studies, contracted research, and collaborative research) (Daiichi Sankyo Co., Ltd., Nippon Boehringer Co., Ltd., Mitsubishi Tanabe Corporation, Tokushima Data Service Co., Ltd., and Astellas Pharm Inc.). Yoshihito Atsumi: speaker fees (Arkray Inc., Astellas Pharm Inc., Nippon Eli Lilly Japan K.K., MSD K.K., Ono Pharmaceutical Co., Ltd., Sanofi K. K., Taisho Toyama Pharmaceutical Co., Ltd., Mitsubishi Tanabe Corporation, Novo Nordisk Co., Ltd., Novartis Pharma K.K., and Nippon Becton–Dickinson Co., Ltd.). Jo Satoh: speaker fees (Astellas Pharm Inc., Nippon Eli Lilly Japan K.K., Ono Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., AstraZeneca, Sanofi K. K., Mitsubishi Tanabe Corporation, Sumitomo Dainippon Pharma Co., Ltd., Nippon Boehringer Co., Ltd., and MSD K.K.). Toshimasa Yamauchi: speaker fees (Takeda Pharmaceutical Co., Ltd., MSD K.K., AstraZeneca); endowed scholarships/donations (Nippon Boehringer Co., Ltd., Novo Nordisk Co., Ltd., Astellas Pharm Inc., Ono Pharmaceutical Co., Ltd., Mitsubishi Tanabe Corporation, Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd., MSK K.K., and Sanofi K. K.)

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Copyright information

© The Japan Diabetes Society 2018

Authors and Affiliations

  • Mitsuyoshi Namba
    • 1
  • Toshio Iwakura
    • 2
  • Rimei Nishimura
    • 3
  • Kohei Akazawa
    • 4
  • Munehide Matsuhisa
    • 5
  • Yoshihito Atsumi
    • 6
  • Jo Satoh
    • 7
  • Toshimasa Yamauchi
    • 8
  • on behalf of the Japan Diabetes Society (JDS) Committee for Surveys on Severe Hypoglycemia
  1. 1.Hyogo College of Medicine College HospitalNishinomiyaJapan
  2. 2.Diabetes and EndocrinologyKobe City Medical Center General HospitalKobeJapan
  3. 3.Department of Diabetes, Metabolism and EndocrinologyJikei University School of MedicineTokyoJapan
  4. 4.Department of Medical InformaticsNiigata University Medical & Dental HospitalNiigataJapan
  5. 5.Diabetes Therapeutics and Research Center, Institute of Advanced Medical SciencesTokushima UniversityTokushimaJapan
  6. 6.Diabetes CenterEiju General HospitalTokyoJapan
  7. 7.Tohoku Medical and Pharmaceutical University Wakabayashi HospitalSendaiJapan
  8. 8.Department of Diabetes and Metabolic Diseases, Graduate School of MedicineUniversity of TokyoTokyoJapan

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