Survey on hypoglycemia among insulin-treated patients with diabetes: The Colombian International Operations Hypoglycemia Assessment Tool population

Abstract

Introduction: The non-interventional International Operations Hypoglycemia Assessment Tool (IO-HAT) study assessed the incidence of hypoglycemia in patients with insulin-treated diabetes across nine countries, including a cohort of patients in Colombia.

Materials and methods: Hypoglycemia incidence among patients with insulin-treated diabetes was assessed across 26 sites in Colombia. Hypoglycaemic events (any, nocturnal or severe) were reported in self-assessment questionnaires (SAQ) and patient diaries based on capillary blood glucose measurement or symptoms. Retrospective events (severe events 6 months before baseline and any event 4 weeks before baseline) were recorded in SAQ, Part 1, and prospective events (4 weeks from baseline) were recorded in SAQ, Part 2, and patient diaries. Differences in hypoglycemia incidence reported in the retrospective and prospective periods were assessed using two-sided tests.

Results: Of the 664 patients assessed, 213 had type 1 diabetes (T1D) and 451 had type 2 diabetes (T2D). Nearly all patients experienced at least one hypoglycaemic event in the prospective period (97.1% T1D; 93.3% T2D). Rates of hypoglycemia (events per personyear, PPY) were higher prospectively than retrospectively for any hypoglycemia (T1D: 121.6 vs. 83.2, p<0.001; T2D: 28.1 vs. 24.6, p=0.127) and severe hypoglycemia (T1D: 15.3 vs. 9.2, p=0.605; T2D: 9.5 vs. 3.5 p=0.040).

Conclusion: These results, the first from a patient-reported dataset on hypoglycemia in insulin-treated patients with diabetes in Colombia, show that patients reported higher rates of any hypoglycemia during the prospective period.

Clinical trial registration number: NCT02306681.

Keywords: Hypoglycemia; diabetes mellitus; insulin infusion systems; Colombia.

Conflict of interest statement

Conflicts of interest: Ana M. Gómez has acted as a speaker for Novo Nordisk, Eli Lilly, MSD, Novartis, Astra Zeneca, Medtronic, and Abbot; she has received funding for research from Novartis and has been part of an advisory board for Abbot, Novo Nordisk, and MSD. Luis G. Chica has acted as a speaker for Novo Nordisk, MSD, Medtronic, and Boehringer Ingelheim; he has received funding for research from Novo Nordisk and has been part of an advisory board for MSD, Novo Nordisk, and Janssen. Álvaro F. Burbano has acted as speaker for Novo Nordisk, Astra Zeneca, Pfizer, Amgen, and Abbott; he has been part of an advisory board for Novo Nordisk and Janssen. Esdras M. Vásquez has been part of an advisory board for Novo Nordisk and has received funding from Novo Nordisk, Sanofi, MSD, Eli Lilly, and Boehringer Ingelheim for continuous medical education. Jorge A. Escobar and Paola M. Arias are employees of Novo Nordisk Colombia S.A.S. Dora I. Molina has no conflict of interests.

Figures

Figure 1. Self-reported hypoglycemia rates

Figure 2. Estimated rate of (A) any hypoglycaemic event in T1D and (B), any hypoglycaemic event in T2D by insulin regimen

Figure 3. (A) Healthcare utilization as a result of hypoglycemia. (B) Patient actions resulting from hypoglycemia in the retrospective and prospective periods