JAMDA 15 (2014) 757e762
JAMDA journal homepage: www.jamda.com
Original Study
Association Between Different Hemoglobin A1c Levels and Clinical Outcomes Among Elderly Nursing Home Residents With Type 2 Diabetes Mellitus Keith L. Davis MA a, *, Wenhui Wei PhD b, Juliana L. Meyers MA a, Brett S. Kilpatrick MA c, Naushira Pandya MD d a
RTI Health Solutions, Research Triangle Park, NC Sanofi US, Inc, Bridgewater, NJ AnalytiCare, LLC, Glenview, IL d Nova Southeastern University College of Osteopathic Medicine, Fort Lauderdale, FL b c
a b s t r a c t Keywords: Elderly long-term care type 2 diabetes mellitus hemoglobin A1c
Objective: New guidelines recommend a target glycated hemoglobin (HbA1c) of 7.5% to 8.0% in elderly persons with type 2 diabetes mellitus (T2DM), but real-world data regarding outcomes associated with different HbA1c levels in the elderly are limited. This study assessed outcomes and their association with defined HbA1c thresholds and age ranges in insulin-treated, elderly, patients with T2DM in long-term care (LTC). Design: Retrospective analysis of medical charts and the Minimum Data Set (MDS) for the period September 2010 through September 2011. Setting: A total of 117 nursing homes in the United States. Participants: Eligible patients had resided in LTC for 3 months or more, had at least 1 full MDS assessment, 2 or more records of insulin dispensing with no pump use, and 1 or more HbA1c measurements. Measurements: Outcomes that were measured included hypoglycemia, ketoacidosis, infections, falls, hospitalization, and emergency room (ER) visits. Results: A total of 583 patients were included (mean age 78.9 years, mean chart observation length 55 days). In all groups, hypoglycemia was lowest in patients with an HbA1c level higher than 9.0%. In patients 75 years or older, infection rates were highest when HbA1c levels were higher than 9.0%. Falls increased by HbA1c level in patients aged 65 to 74 years, but decreased by HbA1c levels in patients 85 years or older. Ketoacidosis, hospitalization, and ER visits were low in all groups. Conclusion: These data suggest that better glycemic levels may not necessarily be associated with better clinical outcomes, and different age groups may exhibit different patterns, thereby supporting the call for individualized glycemic control among elderly patients. Ó 2014 Published by Elsevier Inc. on behalf of AMDA – The Society for Post-Acute and Long-Term Care Medicine.
Diabetes is a common condition among the elderly, affecting an estimated 30% of individuals 65 years or older and a similar proportion of those in long-term care (LTC) in the United States.1,2
This study was funded by Sanofi US, Inc. The authors had access to all data and were responsible for preparing the manuscript for publication. Editorial and writing support was provided by Ewen Legg, PhD, of Excerpta Medica, funded by Sanofi US, Inc. K.L.D. and J.L.M. are employees at RTI Health Solutions, which received funding from Sanofi US, Inc, to conduct this study. W.W. is an employee at Sanofi US, Inc. B.S.K. is an employee at AnalytiCare, LLC, which received funding from Sanofi US, Inc, to conduct this study. N.P. has received speaking honoraria and served as a consultant for Sanofi US, Inc. The authors declare no conflicts of interest. * Address correspondence to Keith L. Davis, MA, RTI Health Solutions, 3040 East Cornwallis Road, Research Triangle Park, NC 27709. E-mail address: [email protected] (K.L. Davis).
Epidemiological projections for 2005 to 2050 in the United States suggest that although the prevalence of diabetes among the general population will double, the increase among individuals 65 years and older will be much greater: up to a 4.5-fold increase.3 Current American Diabetes Association (ADA)/European Association for the Study of Diabetes guidelines support a patient-centered approach in which individualized goals for glycemic control are recommended.4 Factors suggesting that physicians might need to apply looser glycemic control include the strength of a patient’s support system and their ability to manage potentially complex treatment regimens, both of which may be affected by increased age. Management of diabetes in those 65 years or older is further complicated by clinical as well as functional heterogeneity, which must be considered when setting treatment goals.5 Factors, such as renal or hepatic insufficiency, other serious comorbidities, polypharmacy, cognitive
1525-8610/$ - see front matter Ó 2014 Published by Elsevier Inc. on behalf of AMDA – The Society for Post-Acute and Long-Term Care Medicine. http://dx.doi.org/10.1016/j.jamda.2014.06.007
758
K.L. Davis et al. / JAMDA 15 (2014) 757e762
impairment, and diminished counterregulatory responses to hypoglycemia, can lead to a higher risk of hypoglycemia and its complications.6,7 Furthermore, the potential advantages of tight glycemic control, such as reduced risk of microvascular comorbidities over time, carry less weight in the elderly population.5 Therefore, the identification of optimal glycated hemoglobin (HbA1c) levels in older adults represents more of a challenge than in younger individuals. The recent consensus statement by the ADA/American Geriatrics Society (AGS) recommends 3 alternative HbA1c treatment targets depending on the health status of patients.5 Specifically, 7.5% or lower for healthy individuals, 8.0% or lower for individuals with complex/ intermediate health, and 8.5% or lower for individuals with very complex/poor health. Furthermore, a recent ADA position report on the treatment of diabetes in older adults suggests that a glycemic goal of lower than 8.5% should be considered for patients in LTC. 5 Guidelines from other organizations, such as the Diabetes Care Program of Nova Scotia working with the Palliative and Therapeutic Harmonization program, suggest a target A1C higher than 8.0% and lower than 12.0% based on individual circumstances.8 The International Association of Gerontology and Geriatrics, the European Diabetes Working Party for Older People, and an international task force of experts in diabetes concluded that for adults older than 70, the A1C target range should be 7.0% to 7.5%, although the target may need adjusting for those residing in a care home, or with other highdependency states.9 However, studies using real-world data to assess the relationship between the updated HbA1c thresholds and health outcomes in the elderly remain limited. Furthermore, HbA1c levels may not always be an accurate predictor of clinical outcomes.10 Very low HbA1c levels, for example, may be associated with an increased risk of mortality.10 Failing to address very high HbA1c levels may increase the risk of acute metabolic events, chronic complications, and mortality,10 and hypoglycemia may lead to, or worsen, existing cognitive impairment.11 The objective of this study was to examine real-world clinical outcomes associated with different HbA1c levels in elderly patients with insulin-treated type 2 diabetes mellitus (T2DM) residing in nursing homes in the United States. Methods Study Design This was a cross-sectional, retrospective study that used data extracted from medical charts (ie, Medication Administration Record Sheets [MARS]) merged with preexisting data from the Minimum Data Set (MDS). The MDS is a standardized and comprehensive assessment instrument that describes medical diagnoses, chronic health conditions, medication use, cognitive function, psychosocial well-being, functional status, and other aspects of the health of patients residing in LTC facilities. Chart data were used to provide information on patient characteristics, glycemic profiles, and clinical outcomes not captured in the MDS. Data were collected from September 2010 through September 2011. As the study used preexisting, de-identified data, it was exempt from informed consent requirements by an authorized institutional review board committee. Patients Patients eligible for inclusion in the study were newly admitted to the LTC facility after January 1, 2009; resident in a LTC facility for 3 months or longer; had 1 or more full MDS assessments; were diagnosed with T2DM (checked on the MDS form); had 2 or more records of insulin dispensing; and had 1 or more HbA1c measurements.
Exclusion criteria included a diagnosis of type 1 diabetes, receiving pump-administered insulin at any point after LTC admission, and a comatose state or receiving hospice care on, or at any, point after the date of LTC admission. Study Measures The primary objective of the study was to examine clinical outcomes associated with different HbA1c levels in elderly patients with insulin-treated T2DM residing in nursing homes in the United States. The demographic and clinical characteristics of these patients were described, including age, sex, race, body mass index (BMI), assisted daily living status, current comorbidities, concomitant chronic medication use, and use of other noninsulin antidiabetic agents. Outcome measures included prevalence and incidence of hypoglycemia and moderate hypoglycemia (defined as blood glucose
JAMDA journal homepage: www.jamda.com
Original Study
Association Between Different Hemoglobin A1c Levels and Clinical Outcomes Among Elderly Nursing Home Residents With Type 2 Diabetes Mellitus Keith L. Davis MA a, *, Wenhui Wei PhD b, Juliana L. Meyers MA a, Brett S. Kilpatrick MA c, Naushira Pandya MD d a
RTI Health Solutions, Research Triangle Park, NC Sanofi US, Inc, Bridgewater, NJ AnalytiCare, LLC, Glenview, IL d Nova Southeastern University College of Osteopathic Medicine, Fort Lauderdale, FL b c
a b s t r a c t Keywords: Elderly long-term care type 2 diabetes mellitus hemoglobin A1c
Objective: New guidelines recommend a target glycated hemoglobin (HbA1c) of 7.5% to 8.0% in elderly persons with type 2 diabetes mellitus (T2DM), but real-world data regarding outcomes associated with different HbA1c levels in the elderly are limited. This study assessed outcomes and their association with defined HbA1c thresholds and age ranges in insulin-treated, elderly, patients with T2DM in long-term care (LTC). Design: Retrospective analysis of medical charts and the Minimum Data Set (MDS) for the period September 2010 through September 2011. Setting: A total of 117 nursing homes in the United States. Participants: Eligible patients had resided in LTC for 3 months or more, had at least 1 full MDS assessment, 2 or more records of insulin dispensing with no pump use, and 1 or more HbA1c measurements. Measurements: Outcomes that were measured included hypoglycemia, ketoacidosis, infections, falls, hospitalization, and emergency room (ER) visits. Results: A total of 583 patients were included (mean age 78.9 years, mean chart observation length 55 days). In all groups, hypoglycemia was lowest in patients with an HbA1c level higher than 9.0%. In patients 75 years or older, infection rates were highest when HbA1c levels were higher than 9.0%. Falls increased by HbA1c level in patients aged 65 to 74 years, but decreased by HbA1c levels in patients 85 years or older. Ketoacidosis, hospitalization, and ER visits were low in all groups. Conclusion: These data suggest that better glycemic levels may not necessarily be associated with better clinical outcomes, and different age groups may exhibit different patterns, thereby supporting the call for individualized glycemic control among elderly patients. Ó 2014 Published by Elsevier Inc. on behalf of AMDA – The Society for Post-Acute and Long-Term Care Medicine.
Diabetes is a common condition among the elderly, affecting an estimated 30% of individuals 65 years or older and a similar proportion of those in long-term care (LTC) in the United States.1,2
This study was funded by Sanofi US, Inc. The authors had access to all data and were responsible for preparing the manuscript for publication. Editorial and writing support was provided by Ewen Legg, PhD, of Excerpta Medica, funded by Sanofi US, Inc. K.L.D. and J.L.M. are employees at RTI Health Solutions, which received funding from Sanofi US, Inc, to conduct this study. W.W. is an employee at Sanofi US, Inc. B.S.K. is an employee at AnalytiCare, LLC, which received funding from Sanofi US, Inc, to conduct this study. N.P. has received speaking honoraria and served as a consultant for Sanofi US, Inc. The authors declare no conflicts of interest. * Address correspondence to Keith L. Davis, MA, RTI Health Solutions, 3040 East Cornwallis Road, Research Triangle Park, NC 27709. E-mail address: [email protected] (K.L. Davis).
Epidemiological projections for 2005 to 2050 in the United States suggest that although the prevalence of diabetes among the general population will double, the increase among individuals 65 years and older will be much greater: up to a 4.5-fold increase.3 Current American Diabetes Association (ADA)/European Association for the Study of Diabetes guidelines support a patient-centered approach in which individualized goals for glycemic control are recommended.4 Factors suggesting that physicians might need to apply looser glycemic control include the strength of a patient’s support system and their ability to manage potentially complex treatment regimens, both of which may be affected by increased age. Management of diabetes in those 65 years or older is further complicated by clinical as well as functional heterogeneity, which must be considered when setting treatment goals.5 Factors, such as renal or hepatic insufficiency, other serious comorbidities, polypharmacy, cognitive
1525-8610/$ - see front matter Ó 2014 Published by Elsevier Inc. on behalf of AMDA – The Society for Post-Acute and Long-Term Care Medicine. http://dx.doi.org/10.1016/j.jamda.2014.06.007
758
K.L. Davis et al. / JAMDA 15 (2014) 757e762
impairment, and diminished counterregulatory responses to hypoglycemia, can lead to a higher risk of hypoglycemia and its complications.6,7 Furthermore, the potential advantages of tight glycemic control, such as reduced risk of microvascular comorbidities over time, carry less weight in the elderly population.5 Therefore, the identification of optimal glycated hemoglobin (HbA1c) levels in older adults represents more of a challenge than in younger individuals. The recent consensus statement by the ADA/American Geriatrics Society (AGS) recommends 3 alternative HbA1c treatment targets depending on the health status of patients.5 Specifically, 7.5% or lower for healthy individuals, 8.0% or lower for individuals with complex/ intermediate health, and 8.5% or lower for individuals with very complex/poor health. Furthermore, a recent ADA position report on the treatment of diabetes in older adults suggests that a glycemic goal of lower than 8.5% should be considered for patients in LTC. 5 Guidelines from other organizations, such as the Diabetes Care Program of Nova Scotia working with the Palliative and Therapeutic Harmonization program, suggest a target A1C higher than 8.0% and lower than 12.0% based on individual circumstances.8 The International Association of Gerontology and Geriatrics, the European Diabetes Working Party for Older People, and an international task force of experts in diabetes concluded that for adults older than 70, the A1C target range should be 7.0% to 7.5%, although the target may need adjusting for those residing in a care home, or with other highdependency states.9 However, studies using real-world data to assess the relationship between the updated HbA1c thresholds and health outcomes in the elderly remain limited. Furthermore, HbA1c levels may not always be an accurate predictor of clinical outcomes.10 Very low HbA1c levels, for example, may be associated with an increased risk of mortality.10 Failing to address very high HbA1c levels may increase the risk of acute metabolic events, chronic complications, and mortality,10 and hypoglycemia may lead to, or worsen, existing cognitive impairment.11 The objective of this study was to examine real-world clinical outcomes associated with different HbA1c levels in elderly patients with insulin-treated type 2 diabetes mellitus (T2DM) residing in nursing homes in the United States. Methods Study Design This was a cross-sectional, retrospective study that used data extracted from medical charts (ie, Medication Administration Record Sheets [MARS]) merged with preexisting data from the Minimum Data Set (MDS). The MDS is a standardized and comprehensive assessment instrument that describes medical diagnoses, chronic health conditions, medication use, cognitive function, psychosocial well-being, functional status, and other aspects of the health of patients residing in LTC facilities. Chart data were used to provide information on patient characteristics, glycemic profiles, and clinical outcomes not captured in the MDS. Data were collected from September 2010 through September 2011. As the study used preexisting, de-identified data, it was exempt from informed consent requirements by an authorized institutional review board committee. Patients Patients eligible for inclusion in the study were newly admitted to the LTC facility after January 1, 2009; resident in a LTC facility for 3 months or longer; had 1 or more full MDS assessments; were diagnosed with T2DM (checked on the MDS form); had 2 or more records of insulin dispensing; and had 1 or more HbA1c measurements.
Exclusion criteria included a diagnosis of type 1 diabetes, receiving pump-administered insulin at any point after LTC admission, and a comatose state or receiving hospice care on, or at any, point after the date of LTC admission. Study Measures The primary objective of the study was to examine clinical outcomes associated with different HbA1c levels in elderly patients with insulin-treated T2DM residing in nursing homes in the United States. The demographic and clinical characteristics of these patients were described, including age, sex, race, body mass index (BMI), assisted daily living status, current comorbidities, concomitant chronic medication use, and use of other noninsulin antidiabetic agents. Outcome measures included prevalence and incidence of hypoglycemia and moderate hypoglycemia (defined as blood glucose
