Jane Jeffrie Seley

Management of hyperglycemia in hospitalized patients in non-critical care setting: an endocrine society clinical practice guideline

OBJECTIVE The aim was to formulate practice guidelines on the management of hyperglycemia in hospitalized patients in the non-critical care setting. PARTICIPANTS The Task Force was composed of a chair, selected by the Clinical Guidelines Subcommittee of The Endocrine Society, six additional experts, and a methodologist. EVIDENCE This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. CONSENSUS PROCESS One group meeting, several conference calls, and e-mail communications enabled consensus. Endocrine Society members, American Diabetes Association, American Heart Association, American Association of Diabetes Educators, European Society of Endocrinology, and the Society of Hospital Medicine reviewed and commented on preliminary drafts of this guideline. CONCLUSIONS Hyperglycemia is a common, serious, and costly health care problem in hospitalized patients. Observational and randomized controlled studies indicate that improvement in glycemic control results in lower rates of hospital complications in general medicine and surgery patients. Implementing a standardized sc insulin order set promoting the use of scheduled basal and nutritional insulin therapy is a key intervention in the inpatient management of diabetes. We provide recommendations for practical, achievable, and safe glycemic targets and describe protocols, procedures, and system improvements required to facilitate the achievement of glycemic goals in patients with hyperglycemia and diabetes admitted in non-critical care settings.

Round Table Discussion on Inpatient Use of Continuous Glucose Monitoring at the International Hospital Diabetes Meeting

In May 2015 the Diabetes Technology Society convened a panel of 27 experts in hospital medicine and endocrinology to discuss the current and potential future roles of continuous glucose monitoring (CGM) in delivering optimum health care to hospitalized patients in the United States. The panel focused on 3 potential settings for CGM in the hospital, including (1) the intensive care unit (ICU), (2) non-ICU, and (3) continuation of use of home CGM in the hospital. The group reviewed barriers to use and solutions to overcome the barriers. They concluded that CGM has the potential to improve the quality of patient care and can provide useful information to help health care providers learn more about glucose management. Widespread adoption of CGM by hospitals, however, has been limited by added costs and insufficient outcome data.In May 2015 the Diabetes Technology Society convened a panel of 27 experts in hospital medicine and endocrinology to discuss the current and potential future roles of continuous glucose monitoring (CGM) in delivering optimum health care to hospitalized patients in the United States. The panel focused on 3 potential settings for CGM in the hospital, including (1) the intensive care unit (ICU), (2) non-ICU, and (3) continuation of use of home CGM in the hospital. The group reviewed barriers to use and solutions to overcome the barriers. They concluded that CGM has the potential to improve the quality of patient care and can provide useful information to help health care providers learn more about glucose management. Widespread adoption of CGM by hospitals, however, has been limited by added costs and insufficient outcome data.

Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol

Background: Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs. Methods: The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations. Results: A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled “Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program” is attached as supplementary material. Conclusion: This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market.

PRIDE Statement on the Need for a Moratorium on the CMS Plan to Cite Hospitals for Performing Point-of-Care Capillary Blood Glucose Monitoring on Critically Ill Patients

OBJECTIVE A writing committee of the Planning Research in Inpatient Diabetes (PRIDE) group has written this consensus article on behalf of the group in response to a specific request for input from the Centers for Medicare and Medicaid Services (CMS). The purpose of this article is to respond to the March 13, 2015 statement from that agency regarding plans to enforce prohibition of the off-label use of point of care (POC) capillary blood glucose monitor (BGM) testing in most critically ill patients. The article discusses: 1) how POC BGM testing is currently regulated; 2) how POC BGM testing is currently used in the United States; and 3) how POC BGM testing can be safely and effectively regulated in the future through cooperation between the clinician, laboratory, regulatory, industry, and patient communities. PARTICIPANTS Nine members of PRIDE volunteered to write the statement on behalf of the entire group. EVIDENCE Descriptions of current medical practice for critically ill patients were derived from the experience of the authors. Descriptions of the performance of various methods for measuring glucose levels for intensive insulin therapy came from a literature review. CONSENSUS PROCESS Eleven questions were developed by the PRIDE writing group. After extensive electronic and telephone discussion, the article was written and reviewed by all nine authors and then reviewed by two outside experts in the care of critically ill patients. All suggestions by the authors and the outside experts were incorporated. CONCLUSIONS Although the CMS is attempting to protect patients with abnormal glycemic control from harm due to inaccurate POC fingerstick capillary BGM testing, their plan will result in more harm than good. A moratorium on enforcement of the prohibition of off-label use of POC capillary BGM testing is needed.

Best Practices for Interdisciplinary Care Management by Hospital Glycemic Teams: Results of a Society of Hospital Medicine Survey Among 19 U.S. Hospitals

Objective. The Society for Hospital Medicine (SHM) conducted a survey of U.S. hospital systems to determine how nonphysician providers (NPPs) are utilized in interdisciplinary glucose management teams. Methods. An online survey grouped 50 questions into broad categories related to team functions. Queries addressed strategies that had proven successful, as well as challenges encountered. Fifty surveys were electronically distributed with an invitation to respond. A subset of seven respondents identified as having active glycemic committees that met at least every other month also participated in an in-depth telephone interview conducted by an SHM Glycemic Advisory Panel physician and NPP to obtain further details. The survey and interviews were conducted from May to July 2012. Results. Nineteen hospital/hospital system teams completed the survey (38% response rate). Most of the teams (52%) had existed for 1–5 years and served 90–100% of noncritical care, medical critical care, and surgical units. All of the glycemic control teams were supported by the use of protocols for insulin infusion, basal-bolus subcutaneous insulin orders, and hypoglycemia management. However, > 20% did not have protocols for discontinuation of oral hypoglycemic agents on admission or for transition from intravenous to subcutaneous insulin infusion. About 30% lacked protocols assessing A1C during the admission or providing guidance for insulin pump management. One-third reported that glycemic triggers led to preauthorized consultation or assumption of care for hyperglycemia. Institutional knowledge assessment programs were common for nurses (85%); intermediate for pharmacists, nutritionists, residents, and students (40–45%); and uncommon for fellows (25%) and attending physicians (20%). Many institutions were not monitoring appropriate use of insulin, oral agents, or insulin protocol utilization. Although the majority of teams had a process in place for post-discharge referrals and specific written instructions were provided, only one-fourth were supported with written protocols to standardize medication, education, equipment, and follow-up instructions. Conclusion. Inpatient glycemic control teams with NPPs often function in environments without a full set of measurement, education, standardization, transition, and order tools. Executive hospital leaders, community partners, and the glycemic control teams themselves need to address these deficiencies to optimize team effectiveness.

Decreased rates of hypoglycemia following implementation of a comprehensive computerized insulin order set and titration algorithm in the inpatient setting

ABSTRACT Objectives: More than one-third of hospitalized patients have hyperglycemia. Despite evidence that improving glycemic control leads to better outcomes, achieving recognized targets remains a challenge. The objective of this study was to evaluate the implementation of a computerized insulin order set and titration algorithm on rates of hypoglycemia and overall inpatient glycemic control. Methods: A prospective observational study evaluating the impact of a glycemic order set and titration algorithm in an academic medical center in non-critical care medical and surgical inpatients. The initial intervention was hospital-wide implementation of a comprehensive insulin order set. The secondary intervention was initiation of an insulin titration algorithm in two pilot medicine inpatient units. Point of care testing blood glucose reports were analyzed. These reports included rates of hypoglycemia (BG < 70 mg/dL) and hyperglycemia (BG >200 mg/dL in phase 1, BG > 180 mg/dL in phase 2). Results: In the first phase of the study, implementation of the insulin order set was associated with decreased rates of hypoglycemia (1.92% vs 1.61%; p < 0.001) and increased rates of hyperglycemia (24.02% vs 27.27%; p < 0.001) from 2010 to 2011. In the second phase, addition of a titration algorithm was associated with decreased rates of hypoglycemia (2.57% vs 1.82%; p = 0.039) and increased rates of hyperglycemia (31.76% vs 41.33%; p < 0.001) from 2012 to 2013. Conclusions: A comprehensive computerized insulin order set and titration algorithm significantly decreased rates of hypoglycemia. This significant reduction in hypoglycemia was associated with increased rates of hyperglycemia. Hardwiring the algorithm into the electronic medical record may foster adoption.

Meeting the Challenge of Inpatient Diabetes Education: An Interdisciplinary Approach

Teaching diabetes self-management to the growing number of hospitalized patients with diabetes and hyperglycemia is a challenging task. Inpatients are acutely ill and in an environment that is fraught with frequent interruptions and other concerns related to the admitting diagnosis. Because of these competing priorities, limited time, and an ill-conducive learning environment, the primary focus for diabetes self-management education should be on those skills that are essential for the patient to be able to return home safely. This chapter explores the inpatient diabetes self-management education process including assessment, identifying barriers and advantages, goal setting, key topics of content, delivery, communication among providers, and discharge. Practical tips are offered to help integrate diabetes self-management education into current clinical practice in the inpatient setting.

Basal Insulin Use in the Non-Critical Care Setting: Is Fasting Hypoglycemia Inevitable or Preventable?

In an effort to improve glycemic control in inpatients in a large urban academic medical center, we set out to examine risk factors for hypoglycemia associated with basal insulin usage when blood glucose (BG) levels are above target (180 mg/dL). Guidelines recommend use of insulin to prevent hyperglycemia in hospitalized patients,1,2 and randomized trials have shown that regimens that include basal insulin are more effective than rapid-acting insulin alone.3-5 These trials also show that basal insulin increases the rate of hypoglycemia, a fact that likely contributes to clinical inertia on the part of prescribers. Although basal insulin use in inpatients yields significant clinical benefits, it is important to acknowledge and manage the associated risk of iatrogenic hypoglycemia. To that end, we performed a retrospective cohort study using data extracted from the electronic medical record system at a large urban academic medical center. Eligible patients were adults with nonobstetric and non-ICU admissions lasting over 24 hours for whom basal insulin was ordered. The order for basal insulin was the exposure. Insulin glargine was the on-formulary insulin at our institution, and virtually all basal insulin exposures were insulin glargine. Basic demographics and the previous 48 hours of point-of-care BG measurements were covariates. The outcome was fasting hypoglycemia, defined as a BG <70 between 4:00 am and 10:00 am. The covariates were used to construct a hypothesis-based multivariable prediction model with predefined training and validation sets. A total of 3321 admissions between January 1, 2010, and January 1, 2012, were eligible. When basal insulin was ordered, the risk of fasting hypoglycemia per day increased from 1.1% (95% CI 0.9%-1.5%) to 3.2% (95% CI 2.9%-3.5%), with a cumulative probability of 10.7% (95% CI 9.7%-11.8%) for an episode during the 5 days after basal insulin initiation. The rate of nonfasting hypoglycemia did not increase. For patients exposed to basal insulin, low-normal fasting BG (70-99 mg/dl) was associated with an odds ratio of 4.9 (95% CI 3.8-6.2) for next-day fasting hypoglycemia. This corresponded a 10% absolute risk (compared to 2% if fasting BG was > 99), predicting 35% of events with a specificity of 90%. Despite this, when low-normal fasting glucose was present, basal insulin was kept at the same dose in 86% of cases, and titrated up in 4%. A hypothesis-based multivariable prediction model incorporating additional variables (Table 1) had an area under the receiver operator curve of 0.76 in the validation cohort, with a positive predictive value of 16% for the highest-risk decile. Table 1. Multivariable Odds Ratios for Next-day Fasting Hypoglycemia for Inpatients Receiving Basal Insulin. While the original intention of this study was to develop and validate a multivariable prediction algorithm for fasting hypoglycemia, one striking finding is that a low-normal morning blood sugar (70-99 mg/dl) is by itself an effective predictor of hypoglycemia the next morning. This is consistent with previous reports that hypoglycemic episodes in general are often preceded by low-normal glucose levels,6 and with guidelines that low-normal glucose should prompt insulin dose reduction.1 However, this study is the first to quantify the risk associated with low-normal fasting glucose in the setting of basal insulin use, and to show that many providers do not follow common-sense titration practices. These findings support the need for provider education on inpatient insulin titration guidelines. More complex prediction algorithms may be useful, but the most cost-effective way to expand safe use of basal insulin may be provider education about the clinical importance of low-normal fasting BG.

Decreased Rates of Inpatient Hypoglycemia Following Implementation of an Automated Tool in the Electronic Medical Record for Identifying Root Causes

Objective: The objective was to identify root causes of hypoglycemia on medicine inpatient units using an automated tool. Data collected will guide educational interventions aimed at improving patient care and safety by decreasing rates of hypoglycemia. Methods: A survey was conducted among RNs to identify risk factors for hypoglycemia. Survey data were used to create a hypoglycemia root cause survey tool in the EMR. RNs were prompted to utilize the tool when blood glucose (BG) < 70 mg/dL. Once the most common modifiable cause of hypoglycemia was identified, an educational intervention for safe and effective use of insulin was launched. This strategy was designed to empower the care team to reduce the insulin dose when appropriate to prevent future hypoglycemic episodes. Results: BG data were compared from March and April in 2016 and 2017. Rates of hypoglycemia (BG < 70 mg/dL) decreased from 2.3% to 1.5%; BG values in target range (70-180 mg/dL) increased from 59.4% to 65.7%; hyperglycemia (BG > 180 mg/dL) decreased from 38.3% to 32.8% (all P values < .001). The number of patients with recurrent hypoglycemia (3 or more episodes) decreased from 5.7% to 2.2% (P = .044). Conclusions: The two most frequent modifiable causes of hypoglycemia (insulin and nutrition) were identified by an RN survey and confirmed by chart review. A targeted educational intervention addressing safe and effective insulin dosing resulted in a significant decrease in both hypoglycemia and recurrent hypoglycemia. This was associated with an improvement in overall glycemic control. Ongoing clinician education regarding insulin and nutrition accompanied by discussions between RNs and prescribers to address hypoglycemic events in real-time could continue to lower the rate of occurrence.

Evaluation of Several Electronic Glycemic Management Systems

Computerized insulin dosing software provides decision support in the form of pattern management identification, standardized dosing, and ease of use in both the inpatient and outpatient settings. The purpose of this analysis article is to review the features of all three electronic glycemic management systems available in the United States and to discuss the potential benefits of an automated insulin dosing system compared to a paper protocol or electronic order set. Four articles will be presented in this inpatient focused issue that examine the safety and efficacy of the Glytec® eGlycemic Management system in a variety of patient populations.