Burden of Sliding Scale Insulin Use in Elderly Long-Term Care
Residents with Type 2 Diabetes Mellitus
Naushira Pandya, MD,* Wenhui Wei, PhD,
†Juliana L. Meyers, MA,
‡Brett S. Kilpatrick, MA,
§and
Keith L. Davis, MA
‡OBJECTIVES: To examine prevalence, practice patterns, and associated burden of sliding scale insulin (SSI) therapy in elderly adults with type 2 diabetes (T2DM).
DESIGN: A retrospective cross-sectional study assessing merged medical chart data and the Minimum Data Set. SETTING: One hundred seventeen long-term care (LTC) facilities in seven U.S. states.
PARTICIPANTS: Elderly adults with insulin-treated T2DM (N=2,096) admitted to a LTC facility after January 1, 2009, who had been in the facility for at least 3 months before chart abstraction and had received treatment with non-SSI or SSI regimens. The latter were categorized into SSI-only, basal–SSI, prandial–SSI, basal–prandial–SSI, and multiple regimens with SSI. Data were collected from September 2010 through September 2011.
MEASUREMENTS: Demographic and clinical character-istics were recorded. Fingerstick burden was assessed as the average number of fingersticks per week and average number without subsequent insulin administration. Other measures included glycosylated hemoglobin (HbA1c) and hypoglycemia events.
RESULTS: Overall, 73.8% of participants received SSI therapy. SSI-treated participants were more likely to be younger (P=.01), non-white (P= .002), and receiving sul-fonylurea (P=.004) than non-SSI treated participants. SSI therapy was associated with a meanstandard deviation of 19.9 7.9 fingersticks per week, of which 12.57.6 were not followed by insulin administration. Fewer SSI-treated participants than non-SSI SSI-treated participants had one or more HbA1c measurements of 7.0% or less (48.8% vs 57.2%) or 8.5% or less (85.2% vs 87.6%, respectively). Rates of hypoglycemia were similar in both groups (15.0% vs 14.9%).
CONCLUSION: SSI therapy is widely used in LTC facili-ties and is associated with a high fingerstick burden. SSI regimens are associated with poorer glycemic control but a rate of hypoglycemia similar to that of non-SSI regimens. J Am Geriatr Soc 61:2103–2110, 2013.
Key words: sliding scale insulin; elderly adults; type 2 diabetes mellitus; long-term care
O
lder age is a risk factor for the development of type 2 diabetes mellitus (T2DM), with an estimated 10.9 million elderly adults in the United States with the condition and 26.9% of individuals aged 65 and older having T2DM, compared with 8.3% of the total U.S. pop-ulation.1,2 Many elderly adults live in long-term care (LTC) facilities. In 2010, there were approximately 1.7 million nursing home beds in the United States,3 and studies have shown that between one-quarter and almost one-third of elderly U.S. nursing homes residents have T2DM.4–6The use of sliding scale insulin (SSI) therapy to man-age T2DM is common in LTC facilities, as well as in hos-pitals.7,8 SSI treatment refers to the subcutaneous administration of short- or rapid-acting insulin based on a certain threshold of hyperglycemia assessed using finger-stick blood glucose measurement. Basal insulin is not typi-cally administered as part of an SSI regimen, which can result in high blood glucose each morning.9,10 The use of SSI regimens continues to be widespread in hospitals and nursing homes; more than half of all individuals admitted to LTC facilities are started on an SSI regimen, and one-third of those not started immediately are initiated at a later date.7These high levels of use are most likely a result of the perceived convenience, simplicity, and promptness of treatment initiation.8
Despite their widespread use, American Diabetes Asso-ciation (ADA) and American Medical Directors Associa-tion (AMDA) guidelines discourage the use of SSI regimens because they are believed to be neither effective
From the *Department of Geriatrics, and Geriatrics Education Center, College of Osteopathic Medicine, Nova Southeastern University, Ft. Lauderdale, Florida;†Sanofi US, Bridgewater, New Jersey;‡RTI Health Solutions, Research Triangle Park, North Carolina; and§AnalytiCare, LLC, Chicago, Illinois.
Address correspondence to Naushira Pandya, Department of Geriatrics, Nova Southeastern University College of Osteopathic Medicine, 3200 S. University Drive, Ft. Lauderdale, FL 33328. E-mail: pandya@nova.edu DOI: 10.1111/jgs.12547
JAGS 61:2103–2110, 2013 ©2013, Copyright the Authors
in meeting physiological needs nor efficient in inpatient settings. In addition, no standardized clinical protocols are available for SSI regimens, and there is a tendency to use standard doses regardless of their effect on glucose levels.11,12
There are several prominent concerns regarding the use of SSI therapy. First, SSI regimens do not provide a physiological approach to insulin management and, instead, use hyperglycemia as a threshold for therapy. Hyperglycemia can therefore persist for long periods with-out intervention.10 Second, the use of SSI regimens often leads to unpredictable fluctuations in blood glucose levels, because the approach retrospectively aims to treat hyper-glycemia rather than to prevent it.13,14 Third, SSI treat-ment consists of rapid-acting or regular insulin administration and does not provide basal insulin to sup-press hepatic glucose output. This lack of physiological control adds to the risk of developing hyperglycemia.10 Finally, SSI regimens have been associated with suboptimal glycemic control and greater risk of hypoglycemia.8
SSI therapy has been assessed in numerous clinical studies, which have uniformly revealed no clinical benefit of this approach to T2DM management. For example, for the treatment of hyperglycemia in hospitalized indi-viduals with T2DM, the use of a basal–prandial regimen of insulin glargine plus glulisine improved glycemic con-trol more than SSI-only regimens.15–17 SSI therapy has also been associated with a three times greater risk of developing hyperglycemia than with other antidiabetic treatments, demonstrating suboptimal glycemic control with SSI regimens.18 Another study investigated the use of a basal–prandial approach rather than a SSI approach to manage hyperglycemia in hospitalized individuals. The switch to basal–prandial therapy led to better glycemic control.19 Finally, the use of SSI regimens as an addition to routine antidiabetic medications had no effect on rates of hyperglycemia or hypoglycemia or length of hospital-ization.20
Although SSI therapy is used extensively in nursing homes and LTC facilities,7little research on this treatment approach has been performed in these environments. Therefore, the aim of this retrospective study was to assess the burden and clinical outcomes associated with SSI treat-ment in elderly adults with T2DM in selected LTC facili-ties in the United States. The primary objective of the study was to examine the prevalence, practice patterns, and associated burden of SSI therapy in elderly LTC resi-dents with T2DM. Secondary objectives were to compare glycemic control and other clinical outcomes of LTC resi-dents receiving SSI therapy with those of LTC resiresi-dents receiving non-SSI therapy.
METHODS Study Design
This retrospective study used merged medical chart data and the Minimum Data Set (MDS), a comprehensive resi-dent assessment instrument that describes disease diagno-ses, health conditions, cognitive function, psychosocial well-being, and other aspects of the health of LTC resi-dents. The collected chart data were used to provide
information on participants’ demographic characteristics, dosing regimens, glycemic profiles, and other pharmaco-logical treatments that were not captured in the MDS. Data were collected from September 2010 through September 2011.
Participant Selection
Individuals were included in the study if they were newly admitted to the LTC facility after January 1, 2009; had been a resident in the LTC facility for at least 3 months before chart abstraction; had at least one full MDS assess-ment; had a diagnosis of T2DM checked on the MDS form; and had at least two records of insulin dispensing with no insulin pump use. Exclusion criteria were a diag-nosis of type 1 diabetes mellitus, insulin administration by pump at any point after the LTC admission date, or being comatose or in hospice care on or at any point after the LTC admission date.
The study cohort consisted of 2,096 insulin-treated individuals with T2DM from 117 LTC facilities in seven U.S. states (Alabama, Colorado, Georgia, North Carolina, South Carolina, Tennessee, and Texas). LTC facilities from all states would ideally have been included in the study; the participating facilities were selected mostly from the south because of their accessibility, ability to participate in the study, and presence in the researchers’ networks and because they represented a large sample.
Study Measures
Information on demographic and clinical characteristics of the study participants were collected from the records in the MDS (age, sex, race, geographic region, body mass index, assisted daily living status, current comorbidities, and clinical events such as infection, hospitalization, emergency department visits, falls, mortality) and the medical chart (chart data period, insulin treatment charac-teristics, glycemic control, concomitant chronic medica-tion use, use of other noninsulin antidiabetic medicamedica-tions, adverse events such as hypoglycemia and ketoacidosis, information on hospitalizations and emergency depart-ment visits).
Participants were grouped according to whether they used an SSI regimen or an insulin regimen without SSI. The SSI regimens were categorized into five subgroups: SSI only, SSI and basal insulin, SSI and prandial insulin, SSI and basal and prandial insulin, and multiple regimens with SSI (for those who changed insulin regimens). Treatment groups were mutually exclusive.
Using information from the medication administration record sheet (MARS) included in participant medical charts, fingerstick burden associated with SSI treatment was defined as the average number of fingersticks taken per week and the average number of fingersticks taken per week without a subsequent insulin administration.
Measures of glycemic control, as recorded on the med-ical chart, were glycosylated hemoglobin (HbA1c) levels and fasting plasma glucose (FPG) levels, measured once per week as the average of the fingerstick blood sugar lev-els during that week as obtained upon participant awaken-ing before breakfast. Adverse clinical events assessed were
hypoglycemia and severe hypoglycemia (defined as a blood glucose level <50 mg/dL), ketoacidosis, and other clinical events including infections, falls, hospitalizations, and emergency department visits.
Statistical Analyses
Data were descriptively analyzed using means, medians, ranges, and standard deviations (SDs) of continuous vari-ables of interest and frequency distributions for categorical variables. Statistical tests, including Student t-tests (for continuous variables) and chi-square tests (for categorical variables), were used to assess differences in participant characteristics between the treatment groups.
RESULTS
Demographic and Clinical Characteristics
The study cohort consisted of 2,096 insulin-treated indi-viduals with T2DM from 117 LTC facilities in seven U.S. states. The background demographic and clinical charac-teristics of individuals whose data were included in the study are shown in Table 1. The mean age of all partici-pants was 74.012.1, and a median of 56 days of MARS data (range 6–424 days) was available at the time of chart abstraction. Most participants were female (60.1%), 50.5% were white, and more than half required some assistance for their daily living needs (11.7% inde-pendent, 15.0% supervision without assistance, 32.9% limited assistance, and 21.6% extensive assistance or total dependence).
The most common comorbidities were hypertension (49.2%), depression (32.5%), and stroke (23.0%). Almost all participants (95.4%) had chronic medication use, most commonly with antihypertensive drugs (80.0%), anticoag-ulant or antiplatelet drugs (56.1%), and antidepressant drugs (54.9%); 34.3% of participants used concomitant glycemic agents, most commonly sulfonylureas (16.1% of all participants) (Table 1).
Prevalence of SSI Therapy
The majority of participants (73.8%, n=1,547) received SSI treatment (Figure 1), alone or combined with insulin therapy; 30.8% of these were on an SSI-only regimen or on a basal–SSI regimen (28.0%) (Figure 1). The most com-monly used insulins for any SSI therapy were regular insu-lin (49.8%) and insuinsu-lin aspart (43.6%), whereas insuinsu-lin lispro (6.1%) and insulin glulisine (0.5%) were less com-monly used for SSI regimens.
Participants receiving SSI treatment were significantly younger (P=.01; Table 1), less likely to be white (P= .002), and more likely to also be treated with a sulfo-nylurea (P=.004; Table 1) than those not receiving SSI therapy. There were also significant geographical varia-tions in the prevalence of SSI therapy; SSI therapy was used in 100% of participants in Tennessee, 98.2% in Georgia, 87.5% in Alabama, 82.3% in Texas, 69.1% in North Carolina, 66.0% in South Carolina, and 36.5% in Colorado.
Burden of SSI Therapy
The fingerstick burden according to insulin strategy is shown in Figure 2. In all participants receiving any SSI regimen, the mean number of fingersticks per week was 19.97.9 (median 21, range 0–56), but a mean 12.5 7.6 SSI therapy-related fingersticks per week were not followed by insulin dosing because blood glucose levels did not necessi-tate subsequent insulin administration.
Of participants receiving SSI-only regimens, 68.7% of the fingersticks obtained during the week resulted in no insulin administration, compared with 59.5% in the basal– SSI regimen group, 63.8% in the prandial–SSI regimen group, 54.3% in the basal–prandial–SSI regimen group, and 56.0% in the multiple regimen group.
Glycemic Control
Five hundred thirty-five (34.6%) participants who had received any SSI treatment had one or more HbA1c values recorded in their chart, compared with 201 (36.6%) par-ticipants who did not receive SSI treatment. A greater percentage of participants not receiving SSI therapy had one or more HbA1c measurements at or below the ADA treatment goal of 7.0% (57.2%) than of those receiving SSI treatment (48.8%) (Figure 3A). The percentage of par-ticipants with one or more HbA1c measurements at or below the suggested treatment goal of 8.5% for elderly adults with impaired health status 21 was also higher for participants not receiving SSI therapy (87.6%) than for those receiving SSI treatment (85.2%). The proportion of participants being treated with a SSI regimen with one or more HbA1c measurements at or below the target value of HbA1c of 7.0% ranged from 61.8% for SSI-only regimens to 38.9% for basal–prandial SSI regimens and from 69.4% for basal–prandial–SSI regimens to 92.9% for SSI-only regimens for the proportion of participants with one or more HbA1c measurements at or below the treatment goal of 8.5% (Figure 3A).
In participants with one or more HbA1c measure-ments available, mean HbA1c was slightly higher for par-ticipants who received SSI therapy (7.21.3) than for those who did not (7.1 1.3) (Figure 3B). HbA1c levels differed according to SSI treatment regimen (Figure 3B). HbA1c levels were highest with basal–prandial–SSI regi-mens (7.7%), followed by prandial–SSI regimens (7.5%), multiple regimens with SSI therapy (7.4%), basal–SSI regimens (7.4%), and SSI-only regimens (6.8%).
The proportion of participants with one or more FPG measurements at or below the target value of 130 mg/dL was slightly greater for those not receiving SSI treatment (82.4%) than for those receiving SSI therapy (78.7%) (Fig-ure 3A). Furthermore, the proportion of participants with one or more FPG measurements at or below the target value of 130 mg/dL varied depending on the SSI treatment regimen (Figure 3A). This value was highest for those receiving basal–SSI regimens (85.7%) and lowest for those receiving multiple SSI regimens (78.2%). Mean FPG over all mean weekly measurements was 147.544.6 mg/dL for participants receiving SSI treatment and 142.9 39.9 mg/ dL for not receiving SSI treatment. Mean FPG ranged from
136.7 mg/dL for SSI-only regimens to 174.2 mg/dL for basal–prandial–SSI regimens (Figure 3C).
Adverse Events
A similar proportion of participants who received any SSI regimen and who received regimens without SSI incurred
one or more hypoglycemic events (15.0% vs 14.9%) or had one or more severe hypoglycemic events (3.0% vs 3.1%) during follow-up (Table 2). The most common adverse events in this study were infections (14.7% for participants receiving SSI, 13.8% for participants not receiving SSI) and falls (4.3% for participants receiving SSI, 2.9% for participants not receiving SSI). Ketoacidosis Table 1. Participant Demographic Characteristics, Current Comorbidities, Chronic-Use Medications, and Concom-itant Glycemic Agents
Characteristic
All Participants,
N=2,096
Participants with Any
SSI, n=1,547 Participants without SSI, n=549 P -Value Sex, n (%) .10 Male 836 (39.9) 630 (40.7) 206 (37.5) Female 1,260 (60.1) 917 (59.3) 343 (62.5) Age .01 <65, n (%) 478 (22.8) 365 (23.6) 113 (20.6) 65–74, n (%) 538 (25.7) 411 (26.6) 127 (23.1) 75–84, n (%) 627 (29.9) 453 (29.3) 174 (31.7) ≥85, n (%) 453 (21.6) 318 (20.6) 135 (24.6)
MeanSD, median (range) 74.012.1, 75 (28–92) 73.612.2, 74 (28–92) 75.111.5, 76 (35–92)
Race, n (%) .002
White 1,059 (50.5) 751 (48.6) 308 (56.1)
Black 694 (33.1) 524 (33.9) 170 (31.0)
Hispanic 283 (13.5) 227 (14.7) 56 (10.2)
Other 60 (2.9) 45 (2.9) 15 (2.7)
Days of medication administration record sheet record available at time of chart abstraction, meanSD, median (range)
45.626.4, 56 (6–424) 45.028.8, 33.5 (7–424) 47.317.8, 56 (6–151) .08
Body mass index, meanSD 30.49.8 30.39.9 30.79.3 .40 Activity of daily living status, n, (%)
Independent 245 (11.7) 180 (11.6) 65 (11.8) .90
Supervision without assistance 314 (15.0) 244 (15.8) 70 (12.8) Limited assistance 689 (32.9) 493 (31.9) 196 (35.7) Extensive assistance or total dependence 453 (21.6) 339 (21.9) 114 (20.8) Missing or unknown 395 (18.9) 291 (18.8) 104 (18.9) Current comorbidities, n (%) Depression 682 (32.5) 494 (31.9) 188 (34.2) .32 Alzheimer’s disease/dementia 124 (5.9) 92 (6.0) 32 (5.8) .92 Hypertension 1,031 (49.2) 755 (48.8) 276 (50.3) .55 COPD 240 (11.5) 177 (11.4) 63 (11.5) .98 Cancer 40 (1.9) 24 (1.6) 16 (2.9) .04 Stroke 483 (23.0) 353 (22.8) 130 (23.7) .68
Taking chronic-use medications, n (%)
Any 2,000 (95.4) 1,479 (95.6) 521 (94.9) .50
Antihypertensives 1,676 (80.0) 1,243 (80.4) 433 (78.9) .46 Antihyperlipidemics 972 (46.4) 735 (47.5) 237 (43.2) .08 Antidepressants 1,151 (54.9) 843 (54.5) 308 (56.1) .51 Anticoagulants or antiplatelets 1,175 (56.1) 873 (56.3) 302 (55.0) .56 Respiratory agents (anti-COPD) 478 (22.8) 346 (22.4) 132 (24.0) .42 Number of chronic-use medications per participant,
mean (SD)
2.61.2 2.61.2 2.61.2 .50
Taking concomitant antidiabetic agents, n (%)
Any 718 (34.3) 557 (36.0) 161 (29.3) .005
Metformin 447 (21.3) 346 (22.4) 101 (18.4) .05
Glucagon-like peptide 1 analog 2 (0.10) 2 (0.13) 0 .40 Dipeptidyl peptidase 4 inhibitor 64 (3.1) 48 (3.1) 16 (2.9) .83
Thiazolidinediones 69 (3.3) 55 (3.5) 14 (2.6) .26
Sulfonylureas 337 (16.1) 270 (17.6) 67 (12.2) .004
Meglitinides 13 (0.62) 11 (0.71) 2 (0.36) .37
Alpha-glucosidase inhibitors 0 0 0 –
Number of concomitant glycemic agents per participant, meanSD
0.40.7 0.50.7 0.40.6 .66
occurred in few participants; four treated with a basal–SSI regimen, one treated with a SSI-only regimen, and two treated with a regimen without SSI.
DISCUSSION
This study currently represents the largest-scale retrospec-tive study of insulin treatment in LTC residents with T2DM. Merged medical chart and MDS data were used, which offered rich clinical information regarding the treat-ment that participants received and the associated out-comes. The study demonstrated that a large proportion of elderly adults with T2DM in LTC are treated with SSI regimens.
SSI regimens are widely recognized as a nonoptimal approach to blood glucose control in individuals with T2DM and are discouraged in ADA and AMDA clinical guidelines.11,12,14 Despite this, SSI use continues to be widespread in LTC facilities.7 In the current study, SSI therapy was used as a treatment strategy—alone or in
combination with a non-SSI insulin regimen—in 74% of elderly adults with T2DM.
Measures of glycemic control were all poorer in par-ticipants who received any SSI treatment regimen than in those who received regimens without SSI. There is a poten-tial discordance between HbA1c and blood glucose levels, which complicates the analysis of glycemic control in elderly adults.22 The measurement of HbA1c levels may not accurately reflect levels of glycemia in several situa-tions that are frequently observed in older adults, including anemia and other conditions that affect erythrocyte life span. Individuals with anemia and those with a shortened erythrocyte life span have low HbA1c levels.23Hence, the analysis of glycemic control in elderly adults must be performed with great care.
The use of SSI regimens was associated with a high fingerstick burden, with participants receiving an average of 19.9 fingersticks per week. In addition, more than 50% of fingersticks did not result in subsequent insulin adminis-tration. This high fingerstick burden translates into a
Figure 1.Insulin treatment regimens that participants included in the analysis used. SSI =sliding scale insulin.
compromised quality of life for elderly adults because blood glucose levels are monitored frequently, and numer-ous insulin injections are given, thus increasing discom-fort.12Such a high-burden regimen associated with stringent
glycemic goals may not be appropriate for all elderly adults, including those whose care is complicated by advanced micro- or macrovascular complications, extensive comor-bid conditions, or a limited life expectancy.24 A recent A
B
C
Figure 3. Participants receiving sliding scale insulin (SSI) and non-SSI therapy (of those with values available) with≥1 measure-ments at or below glycosylated hemoglobin (HbA1c) ≤7.0%, HbA1c ≤8.5%, and fasting plasma glucose (FPG) ≤130 mg/dL targets (A), mean HbA1c value (B), and mean FPG value (C). SD=standard deviation.
ADA position report on the treatment of diabetes mellitus in older adults suggests that a glycemic goal of less than 8.5% should be considered for LTC residents.21
Impaired cognitive function and dementia, which are prevalent in older adults, have been associated with greater risk of hypoglycemia.25Although certain coexisting medi-cal conditions may necessitate a high degree of glycemic monitoring, T2DM management in elderly adults should include efforts to preserve quality of life and avoid hyper-glycemia and related complications, as well as severe hypo-glycemia.24
In the current study, the proportion of SSI- and non-SSI treated participants who experienced hypoglycemia and severe hypoglycemia was similar, but given the better glycemic control for regimens without SSI and the avoid-ance of the high fingerstick burden associated with SSI reg-imens, elderly adults in LTC facilities being treated with SSI regimens may be better served by changing treatments to a more-physiological insulin regimen.
In addition to their effect on quality of life, wide-spread use of SSI regimens may result in a burden on nurs-ing homes as a result of the nursnurs-ing time required to monitor an individual’s blood glucose levels frequently and administer correction doses12and the cost of supplies due to frequent fingersticks.
There were several limitations to the current study. First, the study cohort, although large, consisted of indi-viduals with T2DM from LTC facilities mostly from the southern U.S. states. It has been reported that there is a high variation in diabetes management in individual U.S. states.26 Furthermore, the LTC population is heteroge-neous with regard to health status and life expectancy. Therefore, this study population may not be generalizable to the overall nursing home population in United States. Second, the study data were collected using medical chart data and MDS and, as such, are potentially subject to cod-ing errors or lack of adequate documentation. Third, although the majority of participants had approximately
2 months of data, the duration of available data on the MARS in this study ranged from 6 to 424 days. Therefore, the between-participant difference in the length of their observation period may have biased the data, and the study findings should be confirmed over a longer duration for all individuals. Finally, this study was retrospective and cross-sectional in nature and therefore not designed to compare clinical outcomes of different insulin treatment regimens. Although bivariate tests were conducted between SSI and non-SSI groups in HbA1c and other outcome mea-sures, these analyses should be considered exploratory and do not suggest causality.
Despite these limitations, this study is in line with pub-lished literature in which the current data show a wide-spread use of SSI therapy and no improvement in rates of hypoglycemia with the use of SSI regimens in elderly LTC residents. In addition to the known disadvantages and lack of evidence supporting the use of SSI regimens, the results of this study show that SSI therapy is associated with a high fingerstick burden, with a significant number of fingersticks not resulting in subsequent insulin administration. These findings further call into question the need for prolonged SSI therapy in elderly LTC residents with T2DM. Future studies into how insulin analogs can simplify and improve care delivery may help to optimize diabetes care in LTC, improving the quality of life of LTC residents.
ACKNOWLEDGMENTS
This work was presented in poster format at the annual meeting of the ADA, June 24–28, 2011, San Diego, Cali-fornia; the National Association of Directors of Nursing Administration National Conference, July 16–20, 2011, Kissimmee, Florida; the American Society for Clinical Pathology annual meeting, October 19–22, 2011, Las Vegas, Nevada; and the American Geriatrics Society Annual Scientific Meeting, May 3–5, 2012, Seattle, Washington.
Table 2. Number and Percentage of Participants with One or More Adverse Events Among the Various Treatment Groups Adverse Event Non-SSI Regimen, n=549 Any SSI Regimen, n=1,547 SSI-Only Regimen, n=646 Basal–SSI Regimen, n=587 Prandial–SSI Regimen, n=8 Basal–Prandial– SSI Regimen, n=80 Multiple Regimens with SSI, n=226 n (%) Hypoglycemia 82 (14.9) 232 (15.0) 66 (10.2) 103 (17.6) 1 (1.5) 24 (30) 38 (16.8) Severe hypoglycemia 17 (3.1) 46 (3.0) 12 (1.9) 18 (3.1) 0 8 (10.0) 8 (3.5) Ketoacidosis 2 (0.36) 5 (0.32) 1 (0.15) 4 (0.68) 0 0 0 Infection Any 76 (13.8) 228 (14.7) 68 (10.5) 86 (14.7) 2 (25.0) 19 (24.8) 53 (23.5) Urinary 51 (9.3) 135 (8.7) 38 (5.9) 52 (8.9) 0 13 (16.3) 32 (14.2) Respiratory 13 (2.4) 54 (3.5) 17 (2.6) 22 (3.8) 0 4 (5.0) 11 (4.9) Wound 11 (2.0) 29 (1.9) 8 (1.2) 9 (1.5) 0 3 (3.8) 9 (4.0) Other 11 (2.0) 51 (3.3) 12 (1.9) 22 (3.8) 2 (25.0) 3 (3.8) 12 (5.3) Falls 16 (2.9) 66 (4.3) 25 (3.9) 23 (3.9) 0 4 (5.0) 14 (6.2) Hospitalization 1 (0.18) 4 (0.26) 1 (0.15) 2 (0.34) 0 0 1 (0.44) Emergency department visits 8 (1.5) 34 (2.2) 13 (2.0) 8 (1.4) 0 4 (5.0) 9 (4.0)
Conflict of Interest: Funding for this study was pro-vided by Sanofi US, Inc. Naushira Pandya received speak-ing honoraria and served as a consultant for Sanofi US, Inc. Wenhui Wei is an employee of Sanofi US, Inc. Brett S. Kilpatrick is an employee of AnalytiCare, LLC, which received funding from Sanofi US, Inc. to conduct this study. Juliana L. Meyers and Keith L. Davis are employees of RTI Health Solutions, which received funding from Sanofi US, Inc. to conduct this study.
Author Contributions: NP, WW, KLD: study design, interpretation of results, development of first draft of man-uscript. BSK: collection and processing of data, interpreta-tion of the results. JLM: statistical analysis, interpretainterpreta-tion of the results. All authors had full access to all of the data in the study; reviewed, edited, and commented on the manuscript during several stages of manuscript develop-ment; and provided final approval for submission.
Sponsor’s Role: The authors received editorial and writing support in the preparation of this manuscript from Rosalie Gadiot, PhD, Excerpta Medica, funded by Sanofi US, Inc.
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