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Real-world crude incidence of hypoglycemia in adults with diabetes: Results of the InHypo-DM Study, Canada
  1. Alexandria Ratzki-Leewing1,
  2. Stewart B Harris1,2,
  3. Selam Mequanint2,
  4. Sonja M Reichert2,
  5. Judith Belle Brown2,
  6. Jason Edward Black1,
  7. Bridget L Ryan1,2
  1. 1 Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
  2. 2 Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
  1. Correspondence to Dr Stewart B Harris; Stewart.Harris{at}schulich.uwo.ca

Abstract

Objective Very few real-world studies have been conducted to assess the incidence of diabetes-related hypoglycemia. Moreover, there is a paucity of studies that have investigated hypoglycemia among people taking secretagogues as a monotherapy or in combination with insulin. Accordingly, our research team developed and validated the InHypo-DM Person with Diabetes Mellitus Questionnaire (InHypo-DMPQ) with the aim of capturing the real-world incidence of self-reported, symptomatic hypoglycemia. The questionnaire was administered online to a national sample of Canadians (≥18 years old) with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) treated with insulin and/or insulin secretagogues.

Research design and methods Self-report data obtained from the InHypo-DMPQ were descriptively analyzed to ascertain the crude incidence proportions and annualized incidence densities (rates) of 30-day retrospective non-severe and 1-year retrospective severe hypoglycemia, including daytime and nocturnal events.

Results A total of 552 people (T2DM: 83%; T1DM: 17%) completed the questionnaire. Over half (65.2%) of the total respondents reported experiencing at least one event (non-severe or severe) at an annualized crude incidence density of 35.1 events per person-year. The incidence proportion and rate of non-severe events were higher among people with T1DM versus T2DM (77% and 55.7 events per person-year vs 54% and 28.0 events per person-year). Severe hypoglycemia was reported by 41.8% of all respondents, at an average rate of 2.5 events per person-year.

Conclusions The results of the InHypo-DMPQ, the largest real-world investigation of hypoglycemia epidemiology in Canada, suggest that the incidence of hypoglycemia among adults with diabetes taking insulin and/or insulin secretagogues is higher than previously thought.

  • hypoglycemia
  • diabetes mellitus
  • incidence
  • InHypo-DM

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Footnotes

  • Contributors AR-L and SBH contributed equally to the development of this manuscript as lead authors; specifically, they conceived and designed the work and were involved in data collection, data analysis and interpretation, drafting of the article, critical revision of the article, and final approval of the version to be published. SM, SMR, JBB, and BLR were involved in the conception and design of the work, data collection, data analysis and interpretation, critical revision of the article, and final approval of the version to be published. JEB was involved in the data analysis and interpretation, critical revision of the article, and final approval of the version to be published. All authors have agreed to be accountable for all aspects of the work.

  • Funding Funding for this study was provided through an investigator-initiated grant from Sanofi Canada.

  • Competing interests SBH: Sanofi: grant, personal fees, member advisory board, consultant; Eli Lilly: grant, personal fees, member advisory board, consultant, clinical studies; Novo Nordisk: grant, personal fees, member advisory board, consultant, clinical studies; Janssen: grant, personal fees, member advisory board, consultant; Merck: personal Fees, member advisory board, consultant; AstraZeneca: grant, personal fees, member advisory board, consultant, clinical studies; Abbott: grant, personal fees, member advisory board, consultant; Boehringer Ingelheim: grant, personal fees, member advisory board, consultant, clinical studies; JDRF: grant; Lawson: grant; Medtronic: personal fees, member advisory board; Amgen: personal fees, member advisory board; Health Canada/First Nations and Inuit Health Branch: grant. SMR: Sanofi: grant, coinvestigator for clinical trials (but with no direct monies for me), fees for presentations; AstraZeneca: grant, coinvestigator for clinical trials (but with no direct monies for me), fees for presentations; Novo Nordisk: grant, coinvestigator of clinical trials, with travel for meetings (but no direct grant monies for me), fees paid for presentations; Boehringer Ingelheim: grant, coinvestigator for clinical trials (but with no direct monies for me), fees for presentations; Servier: grant, coinvestigator of clinical trials, with travel for meetings (but no direct grant monies for me), fees paid for presentations; Janssen: fees paid for presentations; Eli Lilly: fees paid for presentations; Merck: fees paid for presentations; Abbott: fees paid for presentations.

  • Patient consent Obtained.

  • Ethics approval Ethics approval for the conduct of this study was obtained from the Western University Health Sciences Research Ethics Boards (REB# 105992 - 16 December 2014).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No additional data are available.

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