Skip to main content
Top
Published in: BMC Endocrine Disorders 1/2012

Open Access 01-12-2012 | Research article

Severe hypoglycemia symptoms, antecedent behaviors, immediate consequences and association with glycemia medication usage: Secondary analysis of the ACCORD clinical trial data

Authors: Denise E Bonds, Michael E Miller, Jim Dudl, Mark Feinglos, Faramarz Ismail-Beigi, Saul Malozowski, Elizabeth Seaquist, Debra L Simmons, Ajay Sood

Published in: BMC Endocrine Disorders | Issue 1/2012

Login to get access

Abstract

Background

Hypoglycemia is a common complication of diabetes treatment. This paper describes symptoms, predecessors, consequences and medications associated with the first episode of severe hypoglycemia among ACCORD participants with type 2 diabetes, and compares these between intensive (Int: goal A1C <6.0%) and standard (Std, goal A1C 7–7.9%) glycemia intervention groups.

Methods

Information about symptoms, antecedents, and consequences was collected at the time participants reported an episode of severe hypoglycemia. Data on medications prescribed during the clinical trial was used to determine the association of particular diabetes drug classes and severe hypoglycemia.

Results

The most frequently reported symptoms in both glycemia group were weakness/fatigue (Int 29%; Std 30%) and sweating (Int 26%; Std 27%), followed by confusion/disorientation (Int 22%; Std 29%) and shakiness (Int 21%; Std 19%). Approximately half of all events were preceded by a variation in food intake (Int 48%; Std 58%). The most common consequences were confusion (Int 37%; Std 34%), loss of consciousness (Int 25%; Std 25%), and hospitalization (Int 18%; Std 24%). The highest rates of hypoglycemia were found among those participants treated with insulin only (Int 6.09/100 person yrs; Std 2.64/100 person yrs) while the lowest were among those prescribed oral agents only (Int 1.93/100 person yrs; Std 0.20/100 person yrs).

Conclusions

Severe hypoglycemia episodes were frequently preceded by a change in food intake, making many episodes potentially preventable. Symptoms of confusion/disorientation and loss of consciousness were frequently seen. The highest rates of hypoglycemia were seen with prescription of insulin, either alone or in combination with other medications.

Clinical Trial Registration

Number: NCT00000620
Literature
1.
go back to reference Donnelly LA, Morris AD, Frier BM, Ellis JD, Donnan PT, Durrant R, Band MM, Reekie G, Leese GP: Frequency and predictors of hypoglycaemia in Type 1 and insulin-treated Type 2 diabetes: a population-based study. Diabet Med. 2005, 22 (6): 749-755. 10.1111/j.1464-5491.2005.01501.x.CrossRefPubMed Donnelly LA, Morris AD, Frier BM, Ellis JD, Donnan PT, Durrant R, Band MM, Reekie G, Leese GP: Frequency and predictors of hypoglycaemia in Type 1 and insulin-treated Type 2 diabetes: a population-based study. Diabet Med. 2005, 22 (6): 749-755. 10.1111/j.1464-5491.2005.01501.x.CrossRefPubMed
2.
go back to reference Leese GP, Wang J, Broomhall J, Kelly P, Marsden A, Morrison W, Frier BM, Morris AD: Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes: a population-based study of health service resource use. Diabetes Care. 2003, 26 (4): 1176-1180. 10.2337/diacare.26.4.1176.CrossRefPubMed Leese GP, Wang J, Broomhall J, Kelly P, Marsden A, Morrison W, Frier BM, Morris AD: Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes: a population-based study of health service resource use. Diabetes Care. 2003, 26 (4): 1176-1180. 10.2337/diacare.26.4.1176.CrossRefPubMed
3.
go back to reference Johnson ES, Koepsell TD, Reiber G, Stergachis A, Platt R: Increasing incidence of serious hypoglycemia in insulin users. J Clin Epidemiol. 2002, 55 (3): 253-259. 10.1016/S0895-4356(01)00479-6.CrossRefPubMed Johnson ES, Koepsell TD, Reiber G, Stergachis A, Platt R: Increasing incidence of serious hypoglycemia in insulin users. J Clin Epidemiol. 2002, 55 (3): 253-259. 10.1016/S0895-4356(01)00479-6.CrossRefPubMed
4.
go back to reference Bodmer M, Meier C, Krahenbuhl S, Jick SS, Meier CR: Metformin, sulfonylureas, or other antidiabetes drugs and the risk of lactic acidosis or hypoglycemia: a nested case–control analysis. Diabetes Care. 2008, 31 (11): 2086-2091. 10.2337/dc08-1171.CrossRefPubMedPubMedCentral Bodmer M, Meier C, Krahenbuhl S, Jick SS, Meier CR: Metformin, sulfonylureas, or other antidiabetes drugs and the risk of lactic acidosis or hypoglycemia: a nested case–control analysis. Diabetes Care. 2008, 31 (11): 2086-2091. 10.2337/dc08-1171.CrossRefPubMedPubMedCentral
5.
go back to reference Buse JB, Bigger JT, Byington RP, Cooper LS, Cushman WC, Friedewald WT, Genuth S, Gerstein HC, Ginsberg HN, Goff DC: Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods. Am J Cardiol. 2007, 99 (12A): 21i-33i.CrossRefPubMed Buse JB, Bigger JT, Byington RP, Cooper LS, Cushman WC, Friedewald WT, Genuth S, Gerstein HC, Ginsberg HN, Goff DC: Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods. Am J Cardiol. 2007, 99 (12A): 21i-33i.CrossRefPubMed
6.
go back to reference Gerstein HC, Miller ME, Byington RP, Goff DC, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH: Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008, 358 (24): 2545-2559.CrossRefPubMed Gerstein HC, Miller ME, Byington RP, Goff DC, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH: Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008, 358 (24): 2545-2559.CrossRefPubMed
7.
go back to reference Ginsberg HN, Elam MB, Lovato LC, Crouse JR, Leiter LA, Linz P, Friedewald WT, Buse JB, Gerstein HC, Probstfield J: Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med. 2010, 362 (17): 1563-1574.CrossRefPubMed Ginsberg HN, Elam MB, Lovato LC, Crouse JR, Leiter LA, Linz P, Friedewald WT, Buse JB, Gerstein HC, Probstfield J: Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med. 2010, 362 (17): 1563-1574.CrossRefPubMed
8.
go back to reference Cushman WC, Evans GW, Byington RP, Goff DC, Grimm RH, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL: Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010, 362 (17): 1575-1585.CrossRefPubMed Cushman WC, Evans GW, Byington RP, Goff DC, Grimm RH, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL: Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010, 362 (17): 1575-1585.CrossRefPubMed
9.
go back to reference Gerstein HC, Riddle MC, Kendall DM, Cohen RM, Goland R, Feinglos MN, Kirk JK, Hamilton BP, Ismail-Beigi F, Feeney P: Glycemia treatment strategies in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007, 99 (12A): 34i-43i.CrossRefPubMed Gerstein HC, Riddle MC, Kendall DM, Cohen RM, Goland R, Feinglos MN, Kirk JK, Hamilton BP, Ismail-Beigi F, Feeney P: Glycemia treatment strategies in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007, 99 (12A): 34i-43i.CrossRefPubMed
10.
go back to reference Bonds DE, Kurashige EM, Bergenstal R, Brillon D, Domanski M, Felicetta JV, Fonseca VA, Hall K, Hramiak I, Miller ME: Severe hypoglycemia monitoring and risk management procedures in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007, 99 (12A): 80i-89i.CrossRefPubMed Bonds DE, Kurashige EM, Bergenstal R, Brillon D, Domanski M, Felicetta JV, Fonseca VA, Hall K, Hramiak I, Miller ME: Severe hypoglycemia monitoring and risk management procedures in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007, 99 (12A): 80i-89i.CrossRefPubMed
11.
go back to reference Miller ME, Bonds DE, Gerstein HC, Seaquist ER, Bergenstal RM, Calles-Escandon J, Childress RD, Craven TE, Cuddihy RM, Dailey G: The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study. BMJ. 2010, 340: b5444-10.1136/bmj.b5444.CrossRefPubMedPubMedCentral Miller ME, Bonds DE, Gerstein HC, Seaquist ER, Bergenstal RM, Calles-Escandon J, Childress RD, Craven TE, Cuddihy RM, Dailey G: The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study. BMJ. 2010, 340: b5444-10.1136/bmj.b5444.CrossRefPubMedPubMedCentral
12.
go back to reference Deary IJ, Hepburn DA, MacLeod KM, Frier BM: Partitioning the symptoms of hypoglycaemia using multi-sample confirmatory factor analysis. Diabetologia. 1993, 36 (8): 771-777. 10.1007/BF00401150.CrossRefPubMed Deary IJ, Hepburn DA, MacLeod KM, Frier BM: Partitioning the symptoms of hypoglycaemia using multi-sample confirmatory factor analysis. Diabetologia. 1993, 36 (8): 771-777. 10.1007/BF00401150.CrossRefPubMed
13.
go back to reference Akram K, Pedersen-Bjergaard U, Carstensen B, Borch-Johnsen K, Thorsteinsson B: Frequency and risk factors of severe hypoglycaemia in insulin-treated Type 2 diabetes: a cross-sectional survey. Diabet Med. 2006, 23 (7): 750-756. 10.1111/j.1464-5491.2006.01880.x.CrossRefPubMed Akram K, Pedersen-Bjergaard U, Carstensen B, Borch-Johnsen K, Thorsteinsson B: Frequency and risk factors of severe hypoglycaemia in insulin-treated Type 2 diabetes: a cross-sectional survey. Diabet Med. 2006, 23 (7): 750-756. 10.1111/j.1464-5491.2006.01880.x.CrossRefPubMed
14.
go back to reference Davis TM, Brown SG, Jacobs IG, Bulsara M, Bruce DG, Davis WA: Determinants of severe hypoglycemia complicating type 2 diabetes: the Fremantle diabetes study. J Clin Endocrinol Metab. 2010, 95 (5): 2240-2247. 10.1210/jc.2009-2828.CrossRefPubMed Davis TM, Brown SG, Jacobs IG, Bulsara M, Bruce DG, Davis WA: Determinants of severe hypoglycemia complicating type 2 diabetes: the Fremantle diabetes study. J Clin Endocrinol Metab. 2010, 95 (5): 2240-2247. 10.1210/jc.2009-2828.CrossRefPubMed
15.
go back to reference Bennett WL, Maruthur NM, Singh S, Segal JB, Wilson LM, Chatterjee R, Marinopoulos SS, Puhan MA, Ranasinghe P, Block L: Comparative Effectiveness and Safety of Medications for Type 2 Diabetes: An Update Including New Drugs and 2-Drug Combinations. Ann Intern Med. 2011, 154: 602-613.CrossRefPubMedPubMedCentral Bennett WL, Maruthur NM, Singh S, Segal JB, Wilson LM, Chatterjee R, Marinopoulos SS, Puhan MA, Ranasinghe P, Block L: Comparative Effectiveness and Safety of Medications for Type 2 Diabetes: An Update Including New Drugs and 2-Drug Combinations. Ann Intern Med. 2011, 154: 602-613.CrossRefPubMedPubMedCentral
16.
go back to reference Vlckova V, Cornelius V, Kasliwal R, Wilton L, Shakir SA: Hypoglycaemia with oral antidiabetic drugs: results from prescription-event monitoring cohorts of rosiglitazone, pioglitazone, nateglinide and repaglinide. Drug Saf. 2009, 32 (5): 409-418. 10.2165/00002018-200932050-00004.CrossRefPubMed Vlckova V, Cornelius V, Kasliwal R, Wilton L, Shakir SA: Hypoglycaemia with oral antidiabetic drugs: results from prescription-event monitoring cohorts of rosiglitazone, pioglitazone, nateglinide and repaglinide. Drug Saf. 2009, 32 (5): 409-418. 10.2165/00002018-200932050-00004.CrossRefPubMed
17.
go back to reference Buchanan TA, Xiang AH, Peters RK, Kjos SL, Marroquin A, Goico J, Ochoa C, Tan S, Berkowitz K, Hodis HN: Preservation of pancreatic beta-cell function and prevention of type 2 diabetes by pharmacological treatment of insulin resistance in high-risk hispanic women. Diabetes. 2002, 51 (9): 2796-2803. 10.2337/diabetes.51.9.2796.CrossRefPubMed Buchanan TA, Xiang AH, Peters RK, Kjos SL, Marroquin A, Goico J, Ochoa C, Tan S, Berkowitz K, Hodis HN: Preservation of pancreatic beta-cell function and prevention of type 2 diabetes by pharmacological treatment of insulin resistance in high-risk hispanic women. Diabetes. 2002, 51 (9): 2796-2803. 10.2337/diabetes.51.9.2796.CrossRefPubMed
18.
go back to reference Ovalle F, Bell DS: Effect of rosiglitazone versus insulin on the pancreatic beta-cell function of subjects with type 2 diabetes. Diabetes Care. 2004, 27 (11): 2585-2589. 10.2337/diacare.27.11.2585.CrossRefPubMed Ovalle F, Bell DS: Effect of rosiglitazone versus insulin on the pancreatic beta-cell function of subjects with type 2 diabetes. Diabetes Care. 2004, 27 (11): 2585-2589. 10.2337/diacare.27.11.2585.CrossRefPubMed
Metadata
Title
Severe hypoglycemia symptoms, antecedent behaviors, immediate consequences and association with glycemia medication usage: Secondary analysis of the ACCORD clinical trial data
Authors
Denise E Bonds
Michael E Miller
Jim Dudl
Mark Feinglos
Faramarz Ismail-Beigi
Saul Malozowski
Elizabeth Seaquist
Debra L Simmons
Ajay Sood
Publication date
01-12-2012
Publisher
BioMed Central
Published in
BMC Endocrine Disorders / Issue 1/2012
Electronic ISSN: 1472-6823
DOI
https://doi.org/10.1186/1472-6823-12-5

Other articles of this Issue 1/2012

BMC Endocrine Disorders 1/2012 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.