Self-Reported Hypoglycemia in Insulin-Treated Patients with Diabetes: Results from the Philippine Cohort of the International Operations Hypoglycemia Assessment Tool (IO HAT) Study

Abstract

Objective: To determine the frequency of hypoglycemia in insulin-treated patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) in the non-interventional International Operations Hypoglycemia Assessment Tool (IO HAT) study.

Methodology: This sub-analysis included Filipino patients with T1DM or T2DM, aged 18 years and older, treated with insulin for more than 12 months, who completed the two-part self-assessment questionnaires (SAQ1 and SAQ2) and patient diaries that recorded hypoglycemia during retrospective (6 months/4 weeks before baseline) and prospective period (4 weeks after baseline) (ClinicalTrials.gov number: NCT02306681).

Results: A total of 671 patients were enrolled and completed the SAQ1 (62 patients with T1DM and 609 patients with T2DM). Almost all patients (100% in T1DM and 99.3% in T2DM) experienced at least 1 hypoglycemic event prospectively. The incidence of any hypoglycemia was also high in the prospective period compared to retrospective period (72.6 [95% CI: 64.8, 80.9] events PPY and 43.6 [95% CI: 37.8, 49.9] events PPY; p=0.001, respectively) in T1DM patients.

Conclusion: Among insulin-treated patients, higher rates of hypoglycemia were reported prospectively than retrospectively. This indicates that the patients in real-life setting often under-report hypoglycemia. Patient education can help in accurate reporting and appropriate management of hypoglycemia and diabetes.

Keywords: International Operations Hypoglycemia Assessment Tool; Philippines; hypoglycemia; insulin-treated patients with diabetes.

Conflict of interest statement

Novo Nordisk was involved in the study design; collection, analysis and interpretation of data; and decision to submit the article for publication. Authors, Drs. Anand Jain and Arvind Vilas Gadekar are employees of Novo Nordisk. Dr. Roberto Mirasol is a member of the advisory board of Novo Nordisk, Eli Lilly, AstraZeneca, and Merck. Dr. Nemencio Nicodemus, Jr. is a member of the local advisory board of the following companies: Novo Nordisk, AstraZeneca, Merck, Torrent and has received speaker honoraria from Novo Nordisk, AstraZeneca, Merck, Torrent, Eli Lilly, Sanofi, LRI-Therapharma, and Servier. Dr. Susan Yu-Gan has received speaker’s fee from Novo Nordisk and she has taken part in advisory boards for Novo Nordisk Philippines.

© 2018 Journal of the ASEAN Federation of Endocrine Societies.

Figures

Figure 1

IO HAT study design. This study involved both retrospective cross-sectional and prospective observational evaluation, assessed using two-part self-assessment questionnaires (SAQ1 and SAQ2) and patient diary’s that recorded hypoglycemia during retrospective (6 months/4 weeks before baseline) and prospective period (4 weeks after baseline).

Figure 2

Estimated rate of retrospective and prospective hypoglycemia in (a) patients with T1DM and (b) patients with T2DM. Data based on 4-week period for both retrospective and prospective analyses for any or nocturnal hypoglycemia. Retrospective data based on 6-month period and prospective data based on 4-week period for severe hypoglycemia.

Figure 3

Hypoglycemia incidence and event rate in patients with T2DM by insulin regimen: (a) any hypoglycemia, (b) nocturnal hypoglycemia, (c) severe hypoglycemia. Data based on 4-week period for both retrospective and prospective analyses for any or nocturnal hypoglycemia. Retrospective data based on 6-month period and prospective data based on 4-week period for severe hypoglycemia.

Figure 4

Impact of hypoglycemic events on work and study in (a) retrospective and (b) prospective periods. ‘n’ values represent the number of patients studying or in full or part-time employment and completed Part 1 SAQ. Bars represent proportion of subjects responding ‘Yes’.