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
Downloads
References
Aschner P. Epidemiología de la diabetes en Colombia. Avances en Diabetología. 2010;26:95-100. https://doi.org/10.1016/S1134-3230(10)62005-4
Federation ID. IDF Diabetes Atlas. 7th edition. 2016. Accesed on: April 1, 2016. Available at: http://www.diabetesatlas.org
Barnett AH, Cradock S, Fisher M, Hall G, Hughes E, Middleton A. Key considerations around the risks and consequences of hypoglycemia in people with type 2 diabetes. Int J Clin Pract. 2010;64:1121-9. https://doi.org/10.1111/j.1742-1241.2009.02332.x
Davis RE, Morrissey M, Peters JR, Wittrup-Jensen K, Kennedy-Martin T, Currie CJ. Impact of hypoglycemia on quality of life and productivity in type 1 and type 2 diabetes. Curr Med Res Opin. 2005;21:1477-83. https://doi.org/10.1185/030079905x61929
Bonds DE, Miller ME, Bergenstal RM, Buse JB, Byington RP, Cutler JA, et al. The association between symptomatic, severe hypoglycemia and mortality in type 2 diabetes: Retrospective epidemiological analysis of the ACCORD study. BMJ. 2010;340:b4909. https://doi.org/10.1136/bmj.b4909
Brod M, Wolden M, Christensen T, Bushnell DM. Understanding the economic burden of nonsevere nocturnal hypoglycemic events: Impact on work productivity, disease management, and resource utilization. Value Health. 2013;16:1140-9. https://doi.org/10.1016/j.jval.2013.09.002
Elliott L, Fidler C, Ditchfield A, Stissing T. Hypoglycemia event rates: A comparison between real-world data and randomized controlled trial populations in insulin-treated diabetes. Diabetes Ther. 2016;7:45-60. https://doi.org/10.1007/s13300-016-0157-z
Khunti K, Alsifri S, Aronson R, Cigrovski Berkovic M, Enters-Weijnen C, Forsen T, et al. Rates and predictors of hypoglycemia in 27 585 people from 24 countries with insulintreated type 1 and type 2 diabetes: The global HAT study. Diabetes Obes Metab. 2016;18:907-15. https://doi.org/10.1111/dom.12689
Brod M, Galstyan G, Unnikrishnan AG, Harman-Boehm I, Prusty V, Lavalle F, et al. Self-treated hypoglycemia in type 2 diabetes mellitus: Results from the second wave of an international cross-sectional survey. Diabetes Ther. 2016;7:279-93. https://doi.org/10.1007/s13300-016-0164-0
Lamounier RN, Geloneze B, Oliveira Leite S, Montenegro Jr. R, Zajdenverg L, Fernandes M, et al. Hypoglycemia incidence and awareness among insulin-treated patients with diabetes: The HAT study in Brazil. Diabetol Metab Syndr. 2018;10:83. https://doi.org/10.1186/s13098-018-0379-5
World Medical Association. Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA. 2013;310:2191-4. https://doi.org/10.1001/jama.2013.281053
International Society for Pharmacoepidemiology. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008;17:200-8. https://doi.org/10.1002/pds.1471
American Diabetes Association. Defining and reporting hypoglycemia in diabetes: A report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005;28:1245-9.
Pedersen-Bjergaard U, Pramming S, Thorsteinsson B. Recall of severe hypoglycaemia and self-estimated state of awareness in type 1 diabetes. Diabetes Metab Res Rev. 2003;19:232-40. https://doi.org/10.1002/dmrr.377
Vargas-Uricoechea H, Casas-Figueroa LA. An epidemiologic analysis of diabetes in Colombia. Ann Glob Health. 2015;81:742-53. https://doi.org/10.1016/j.aogh.2015.11.001
Gómez AM, Marín-Sánchez A, Muñoz OM, Colón-Peña CA. Numerical and clinical precision of continuous glucose monitoring in Colombian patients treated with insulin infusion pump with automated suspension in hypoglycemia. Endocrinol Nutr. 2015;62:485-92. https://doi.org/10.1016/j.endonu.2015.06.012
Aschner P, Aguilar-Salinas C, Aguirre L, Franco L, Gagliardino JJ, de Lapertosa SG, et al. Diabetes in South and Central America: An update. Diabetes Res Clin Prac. 2014;103:238-43. https://doi.org/10.1016/j.diabres.2013.11.010
Machado-Alba JE, Moncada-Escobar JC, Gaviria H. Quality and effectiveness of diabetes care for a group of patients in Colombia. Rev Panam Salud Pública. 2009;26:529-35.
Kuo YF, Raji MA, Markides KS, Ray LA, Espino DV, Goodwin JS. Inconsistent use of diabetes medications, diabetes complications, and mortality in older mexican americans over a 7-year period: Data from the Hispanic established population for the epidemiologic study of the elderly. Diabetes Care. 2003;26:3054-60. https://doi.org/10.2337/diacare.26.11.3054
Heller SR, Frier BM, Hersløv ML, Gundgaard J, Gough SC. Severe hypoglycaemia in adults with insulin-treated diabetes: Impact on healthcare resources. Diabetic Med. 2016;33:471-7. https://doi.org/10.1111/dme.12844
Heise T, Hermanski L, Nosek L, Feldman A, Rasmussen S, Haahr H. Insulin degludec: Four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab. 2012;14:859-64. https://doi.org/10.1111/j.1463-1326.2012.01627.x
Some similar items:
- Luis Eduardo Echeverría, Clara Saldarriaga, Sebastián Campbell-Quintero, Lisbeth Natalia Morales-Rodríguez, Juan David López-Ponce de León, Andrés Felipe Buitrago, Erika Martínez-Carreño, Jorge Alberto Sandoval-Luna, Alexis Llamas, Gustavo Adolfo Moreno-Silgado, Julián Vanegas-Eljach, Nelson Eduardo Murillo-Benítez, Ricardo Gómez-Paláu, Alex Arnulfo Rivera-Toquica, Juan Esteban Gómez-Mesa, RECOLFACA research group, Diabetes mellitus in patients with heart failure and effect modification of risk factors for short-term mortality: An observational study from the Registro Colombiano de Falla Cardíaca (RECOLFACA) , Biomedica: Vol. 44 No. Sp. 1 (2024): Enfermedades crónicas no transmisibles
- Argemiro Fragozo, María Fernanda Puerta, Juan Diego Misas, Comparative analysis of insulin glargine vs. insulin detemir: A cost-minimization study applicable to Colombia , Biomedica: Vol. 35 No. 2 (2015)
- Constanza Pardo, Ricardo Cendales, Survival analysis of cervical cancer patients , Biomedica: Vol. 29 No. 3 (2009)
- Raúl Murillo, Ricardo Cendales, Carolina Wiesner, Marion Piñeros, Sandra Tovar, Effectiveness of cytology-based cervical cancer screening in the Colombian health system , Biomedica: Vol. 29 No. 3 (2009)
- Sandra Lorena Girón, Julio César Mateus, Fabián Méndez, Impact of an open waste disposal site on the occurrence of respiratory symptoms and on health care costs of children , Biomedica: Vol. 29 No. 3 (2009)
- José Joaquín Carvajal, Ligia Inés Moncada, Mauricio Humberto Rodríguez, Ligia del Pilar Pérez, Víctor Alberto Olano, Characterization of Aedes albopictus (Skuse, 1894) (Diptera:Culicidae) larval habitats near the Amazon River in Colombia , Biomedica: Vol. 29 No. 3 (2009)
- Andrés Páez, Gloria Rey, Carlos Agudelo, Alvaro Dulce, Edgar Parra, Hernando Díaz-Granados, Damaris Heredia, Luis Polo, Outbreak of urban rabies transmitted by dogs in Santa Marta, northern Colombia , Biomedica: Vol. 29 No. 3 (2009)
- Patricia Escobar, Katherine Paola Luna, Indira Paola Hernández, César Mauricio Rueda, María Magdalena Zorro, Simon L. Croft, In vitro susceptibility of Trypanosoma cruzi strains from Santander, Colombia, to hexadecylphosphocholine (miltefosine), nifurtimox and benznidazole , Biomedica: Vol. 29 No. 3 (2009)
- Gustavo Pradilla, Julio César Mantilla, Reynaldo Badillo, Human rabies encephalitis by a vampire bat bite in an urban area of Colombia , Biomedica: Vol. 29 No. 2 (2009)
- Mauricio Beltrán, María Cristina Navas, María Patricia Arbeláez, Jorge Donado, Sergio Jaramillo, Fernando De la Hoz, Cecilia Estrada, Lucía del Pilar Cortés, Amalia de Maldonado, Gloria Rey, Seroprevalence of hepatitis B virus and human immunodeficiency virus infection in a population of multiply-transfused patients in Colombia , Biomedica: Vol. 29 No. 2 (2009)
| Article metrics | |
|---|---|
| Abstract views | |
| Galley vies | |
| PDF Views | |
| HTML views | |
| Other views | |
