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Diabetes mellitus is a leading cause of morbidity and mortality in the United States. Approximately 20.8 million people in the United States (7% of the population) have diabetes, and approximately 90% to 95% of people with diabetes have type 2 diabetes. The incidence rate of diabetes in the United States for 2005 is 1.5 million cases in people age 20 years or older. Various trials have validated the need for tight glycemic control. Various important indices used to measure blood glucose levels include fasting or preprandial glucose, 2-hour postprandial glucose, bedtime glucose, and hemoglobin A1c levels. The terms glycosylated hemoglobin or glycated hemoglobin are also used in the literature in lieu of hemoglobin A1c.
The purpose of this paper is to present the available guidelines from various organizations to help internists and other primary care physicians with effective management for glycemic control in type 2 diabetes mellitus and target level for hemoglobin A1c. The target population for this guideline is all patients with type 2 diabetes. This evidence is based on the review of the guidelines presented in this paper. This guidance statement is derived from other organizations' guidelines and is based on an evaluation of strengths and weaknesses of the available guidelines.
This guidance statement is derived from other organizations' guidelines and is based on an evaluation of the strengths and weaknesses of the available guidelines. We used the Appraisal of Guidelines, Research and Evaluation in Europe (AGREE) appraisal instrument to evaluate the guidelines from various organizations. On the basis of the review of the available guidelines, we recommend:
Statement 1: To prevent microvascular complications of diabetes, the goal for glycemic control should be as low as is feasible without undue risk for adverse events or an unacceptable burden on patients. Treatment goals should be based on a discussion of the benefits and harms of specific levels of glycemic control with the patient. A hemoglobin A1c level less than 7% based on individualized assessment is a reasonable goal for many but not all patients.
Statement 2: The goal for hemoglobin A1c level should be based on individualized assessment of risk for complications from diabetes, comorbidity, life expectancy, and patient preferences.
Statement 3: We recommend further research to assess the optimal level of glycemic control, particularly in the presence of comorbid conditions.
From the ACP Diabetes Care Guide
Many factors affect the ability of patients to achieve and maintain near-normal blood glucose levels. Collaboratively developed glycemic goals should take into consideration the patient's age, comorbidities, physical limitations, lifestyle, occupation, support system, and financial resources. The patient's ability to recognize and appropriately treat hypoglycemia should be considered as well.
Topics covered in this chapter include:
- Blood Glucose Pattern Management
- The Role of Postprandial Blood Glucose Monitoring
- Blood Glucose Monitors
- Recording Blood Glucose Results
- Hemoglobin A1C
- Fructosamine
NOTE: You may order free copies of the complete ACP Diabetes Care Guide (book and CD-ROM).
From the ACP Diabetes Care Guide
Persons with diabetes have a 2- to 4-fold higher hospitalization rate than do those without diabetes. Diabetes predisposes to a number of conditions that may lead to hospitalization, including coronary artery disease, cerebrovascular disease, peripheral vascular disease, nephropathy, and infection. Poorly controlled diabetes has been associated with increased infectious complications, delayed wound healing, increased medical costs, increased length of stay, and increased mortality.
The general goals for patients with diabetes in the acute care setting are:
- Avoiding hypoglycemia or hyperglycemia
- Avoiding metabolic abnormalities, such as volume depletion or electrolyte abnormalities
- Meeting nutritional needs
- Assessing educational needs
NOTE: You may order free copies of the complete ACP Diabetes Care Guide (book and CD-ROM).
From the ACP Diabetes Care Guide
All persons involved in the care of persons with diabetes need to be able to determine when hospitalization is warranted. General hospital admission guidelines for diabetes are summarized (in this chapter). When counseling patients about hypoglycemia and hyperglycemia, emphasize that the best treatment is prevention: be proactive by recognizing the signs early, be prepared to treat, treat appropriately, and seek prompt attention when needed. It is always better to err on the side of safety.
NOTE: You may order free copies of the complete ACP Diabetes Care Guide (book and CD-ROM).
ACP Summer Session was a two-day CME event that covered key topics and management strategies in the areas of cardiology, diabetes, pulmonary diseases, and neurological diseases. ACP Summer Session was held in Orlando, Florida on August 7-8, 2009 and in San Francisco, California on August 14-15, 2009. The following audio recordings with synchronized slides and course handouts are from the Orlando meeting and are available free to ACP members.
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Determine how often blood glucose should be checked.
Effective and efficient analysis of blood glucose records.
Use of "pattern management" of blood glucose records to make decisions regarding diabetes care.
This session answers the following questions:
- How should diabetic patients be managed in the operative and perioperative period?
- What is the role of insulin in the critically ill patient?
- How has availability of new insulins (glargine, lispro) changed the approach to therapy?
- What strategies can be used to initiate IV insulin infusions in non-ICU environments?
In a new randomized controlled trial, both aerobic and resistance exercise improved glycemic/blood sugar control in people with type 2 diabetes. The greatest improvements came from combined aerobic and resistance training.
The study included 251 adults, between ages 39 and 70, who were not exercising regularly and had type 2 diabetes. Participants were assigned to one of four groups: performing 45 minutes aerobic training three times per week, 45 minutes of resistance training three times per week, 45 minutes each of both three times per week, or no exercise.
Glucose testing with GDH-PQQ strips could lead to fatal errors in patients consuming nonglucose sugars, the FDA reported in a public health notification last week.
Because GDH-PQQ test strips do not distinguish between types of sugars, they may falsely indicate hyperglycemia in patients consuming products containing non-glucose sugars such as maltose, xylose and galactose. This can lead to inappropriate dosing and administration of insulin, potentially resulting in hypoglycemia, coma or death, the FDA said. In addition, actual hypoglycemia could be missed if patients and practitioners rely only on the GDH-PQQ test result. From 1997 to 2009, the FDA has received 13 reports of deaths associated with GDH-PQQ glucose test strips where interference from maltose or other non-glucose sugars was documented.
The FDA noted that this problem does not apply to other glucose test strip methods or laboratory-based blood glucose assays. A list of recommendations to reduce the risk associated with GDH-PQQ test strips is available online.
Older patients with diabetes who were prescribed an antipsychotic drug had a significantly increased risk of hospitalization for hyperglycemia, particularly during the initial course of treatment, a recent study reported.
In the nested case-control, population-based study, researchers looked at records of patients age 66 years or older with diabetes who started taking an antipsychotic drug between April 1, 2002 and March 31, 2006 and were followed for up to five years from treatment start until March 31, 2007. Subjects were divided into three groups: insulin-treated, oral hypoglycemic agent only-treated, and no diabetes treatment. Antipsychotic treatment was associated with a higher risk of hyperglycemia compared with remote antipsychotic use in all diabetes treatment groups, with the risk highest among patients treated with atypical and typical agents, especially those just starting treatment. The results appear in the July 27 Archives of Internal Medicine.
The findings stress the importance of enhanced glycemic monitoring after initiation of antipsychotic therapy in older patients with diabetes, the authors said. Noting the prevalence of diabetes, the widespread use of antipsychotic drugs, and recent warnings regarding higher risk of stroke and death with antipsychotic agents, the authors recommended more careful consideration of the risks and benefits before prescribing them to vulnerable patients.
Further study is needed to determine whether the findings represent a causal effect of antipsychotics, said the authors. For now, physicians should consider other options to manage behavioral symptoms of dementia in older persons with diabetes, and families should be alerted to watch for signs of glycemic decompensation after antipsychotics are initiated, they said.
A long-term study further quantified the well-known benefits of intensive glucose control for patients with type 1 diabetes.
The analysis included patients from the Diabetes Control and Complications Trial (DCCT), which from 1983-1993 randomized diabetics to either intensive insulin therapy or what was at the time conventional therapy. The intensive group aimed for near-normal glycemic control with three or more daily injections or a pump. The conventional group received one or two injections and had no specific A1C target. For the new analysis, researchers also included 161 patients from an observational study who matched the DCCT criteria.
Overall, the analysis found that, after 30 years of diabetes, the cumulative incidence rates of proliferative retinopathy, nephropathy and cardiovascular disease were 50%, 25% and 14% in the conventional arm. Patients in the other observational trial had similar rates, 47%, 17% and 14% respectively. DCCT patients who received intensive control had substantially lower rates, 21% developed retinopathy, 9% nephropathy and 9% cardiovascular disease. In that group, fewer than 1% went blind, received a kidney transplant or had an amputation. The study was published in the July 27 Archives of Internal Medicine.
Neither low A1c levels nor hypoglycemia were to blame for the increased deaths found in the intensive control arm of the ACCORD trial, according to follow-up data from the study.
At the American Diabetes Association's Scientific Sessions last week, researchers presented new information about the excess deaths that occurred among patients with an A1c target under 6%. Last year, the study had reported a 20% increased death in the intensive control arm compared with patients with a target of 7% to 7.9%. However, additional analyses reported in a meeting press release found that patients who had a greater decline in A1c actually had a lower risk of death. An A1c under 7% was not a predictor of mortality risk, and for every 1% a patient's A1c increased over 6%, there was a 20% higher risk of death, the researchers reported.
Patients who had severe hypoglycemia during the trial were more likely to die, a separate analysis found. But patients in the intensive group who had hypoglycemia were less likely to die than those in the standard group who developed it. Although 7% of the 451 patients who died during the study had at least one severe hypoglycemic event, researchers identified only one case where the hypoglycemia definitely played a role in a patient's death. They theorized that patients in the intensive arm may have better learned how to recognize and treat hypoglycemia because they had more frequent episodes and greater interaction with providers.
ACCORD study authors said they are continuing to look for causes of the increased mortality. Although part of the trial was halted when the excess deaths were reported, the study has continued and will end June 30. Complete analyses, which also include research on blood pressure and lipid control, should be completed within the next year.
A large study of elderly patients hospitalized with heart failure found no significant association between elevated glucose levels at admission and mortality, whether or not patients had diabetes.
In the study, published in the April 14 Circulation, researchers evaluated more than 50,000 elderly patients hospitalized with heart failure between 1998-2001 and analyzed the association between admission glucose and all-cause mortality using multivariable Cox regression models. They found no significant relationship between glucose and 30-day or one-year mortality, even though the hyperglycemic heart failure patients had more severe heart failure on admission. Results did not differ between patients with or without diabetes.
The results demonstrate that the strong association between glucose and increased mortality risk seen in patients with acute myocardial infarction may not extend to patients with heart failure, the authors noted. They stressed that more disease-specific study on the relationship between glucose and patient outcomes may be needed before hospitals devote substantial resources to glycemic management strategies for all patients.
Intensive glucose control increases the mortality of critically ill patients compared with conventional glucose control, a large new study found.
The NICE-SUGAR trial included 6,104 patients who were admitted to intensive care units at 42 hospitals and expected to remain there for three or more days. The patients were randomized to either intensive glucose control (a target blood glucose range of 81 to 108 mg/dL) or conventional control (target of 180 mg/dL or less). The primary outcome was death within 90 days. The study was released online by The New England Journal of Medicine on March 24.
Patients in the intensive control group had a higher risk of death (27.5% died vs. 24.9% in the conventional-control group; odds ratio, 1.14). The intensive group had higher rates of severe hypoglycemia (6.8% vs. 0.5%) but there was no significant difference in the time spent in the ICU, in the hospital, on mechanical ventilation or on renal-replacement therapy. The treatment effect did not differ between surgical and medical patients.
These findings contradict the 2001 Van den Berghe trial, which led many hospitals to institute intensive glucose control measures, noted an accompanying editorial. The editorialists suggested several possible explanations for the association of intensive control with mortality, including negative affects of insulin, consequences of hypoglycemia, less attention to other management practices, or some healing value to stress hyperglycemia.
Regardless of the causes, both the editorialists and the study authors concluded that there is no additional benefit to lowering ICU patients' blood glucose levels below about 140 to 180 and that lower targets could potentially harm patients. Greater explanation of the factors involved, and impacts on particular patient subgroups, should come from post hoc analyses of the trial, the editorial said.
A documentary on diabetes, for which physicians can earn CME credit, debuted on the Discovery Channel this month. The documentary, "Diabetes: A Global Epidemic" can also be viewed online or downloaded as a podcast.
The documentary is divided into four hour-long segments:
- Insulin initiation: glycemic control with postprandial glucose monitoring
- Effectively managing anticoagulation
- Insulin initiation: targeting type 2 diabetes
- Diabetes: A global epidemic
The series is supported by an unrestricted educational grant to Discovery Health from Novo Nordisk.
Thiazolidinediones, primarily rosiglitazone (Avandia), increase the risk of congestive heart failure, acute myocardial infarction and death for older patients with diabetes, a new study found.
The retrospective cohort study used health care databases in Ontario to examine 159,026 diabetes patients age 66 years and older who had been treated with at least one hypoglycemic agent between 2002 and 2005. Follow up was for a median of 3.8 years. The study was published in the Dec. 12 Journal of the American Medical Association.
Patients treated with thiazolidinedione monotherapy had a 60% higher risk of congestive heart failure, a 40% higher risk of acute myocardial infarction and a 29% higher risk of death compared with people taking other hypoglycemic agent combination therapies. Patients treated with thiazolidinedione combination therapy had a 31% higher risk of congestive heart failure, and a 24% higher risk of death, but no higher risk of heart attack, compared with those taking other therapies. The association between thiazolidinedione treatment and cardiac events appears limited to rosiglitazone, the authors said.
Past research has indicated that rosiglitazone and pioglitazone may increase the risk of congestive heart failure, while two meta-analyses have suggested rosiglitazone may increase the risk of acute myocardial infarction. The FDA recently added boxed warnings to the drugs' labels to reflect these risks, but has stopped short of recommending that the drugs be pulled from the market.
"These findings provide evidence from a real-world setting and support data from clinical trials that the harms of thiazolidinediones may outweigh their benefits," though further studies are needed, the authors said. For now, clinicians need to weigh the potential benefits and harms of treatment on an individual basis, especially with high-risk elderly populations, they said.
Intensive insulin therapy may have a renoprotective effect in critically ill patients, according to a new study.
Two previously published randomized, controlled trials have indicated that tight glucose control protects the kidneys in critically ill patients. Researchers reanalyzed data from these trials to more closely examine the effect of intensive insulin therapy on renal function. The results appear in the March Journal of the American Society of Nephrology.
The study involved data from 2,707 critically ill medical and surgical patients who did not have end-stage renal disease before hospital admission and were randomly assigned to receive intensive or conventional insulin therapy during hospitalization. Overall, the incidence of acute kidney injury was statistically significantly lower in patients receiving intensive insulin therapy than in those receiving conventional therapy (4.5% vs. 7.6%). A greater renoprotective effect was seen among patients who maintained normal glucose levels.
In surgical patients, oliguria and the need for renal replacement therapy were statistically significantly less common in those receiving intensive insulin therapy compared with conventional therapy (2.6% vs. 5.6% and 4.0% vs. 7.4%, respectively). Medical patients did not derive as much renoprotective benefit from intensive insulin therapy, possibly because patients in this group are usually sicker at hospital admission.
The authors acknowledged several limitations of their study, including examination of a secondary outcome and the limited sample size of some subgroups. However, they concluded that tight glucose control has a renoprotective effect in the critically ill, especially surgical patients.
A large government trial of diabetes treatments was halted last week after it was found that intensive efforts to lower patients? blood sugar were associated with higher mortality rates.
The ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial included more than 10,000 patients who had diabetes and at least two other risk factors for heart disease. The patients were randomized to either intensively low blood sugar goals (A1c of less than 6%) or standard goals and treatment (A1c between 7% and 7.9%). Over the almost four-year study period, 257 patients in the intensive group had died, compared with 203 patients in the standard group, NIH officials announced last week. Based on that survival difference (which works out to 3 deaths per 1,000 participants per year), officials decided to halt the intensive treatment arm of the trial.
The researchers have not uncovered an explanation for the difference in survival, although an investigation is ongoing. Overall, death rates in both groups were lower than in similar populations in other studies. Because of recent concerns, the researchers specifically looked at rosiglitazone for a link to the increased deaths, but they found no association. The standard treatment arm of the ACCORD study, as well as related trials of blood pressure and lipid treatment, will continue until the planned conclusion date of June 2009.
Interim results from a large international diabetes study do not confirm findings that recently halted a large U.S. trial, researchers announced last week. The new findings increased debate about how intensive treatment of blood sugar in high-risk diabetic patients affects mortality.
The ACCORD trial, a large NIH-funded study of diabetes treatment, stopped its intensive treatment arm two weeks ago after researchers found a link between treating patients to low blood sugar goals and increased mortality. Concern about the ACCORD trial's findings led researchers on the ADVANCE study, an international trial involving 11,140 high-risk patients with diabetes, to evaluate their data for a similar link.
They found no confirmation of the adverse mortality trend reported by the ACCORD trial, according to the chairman of the ADVANCE Data Monitoring and Safety Committee. He also noted that the ADVANCE trial was based on twice as much data and similar glucose targets as the ACCORD trial. Patients in the ADVANCE trial had an A1c goal of less than 6.5% while ACCORD patients in the low-target group had an average A1c of 6.4%.
Full data from the ADVANCE trial are not yet available, because the arm of the study that assessed the effects of intensive blood sugar treatment was only completed in January. The study began in July 2001 and patients were treated and followed for an average of five years. Researchers said that results are more than 99% complete, so the interim findings should be a reliable guide to the final results. The study should be available in the spring, representatives said.
Doctors and patients should be reassured that the mortality trend found in the U.S. study was not confirmed by the international trial, although more definitive analyses are needed, said a representative of the ADVANCE trial. The results of a third trial, expected later this year, should help to clarify the issue, according to the American Diabetes Association. The association also reaffirmed its recommendation that most people with diabetes work toward an A1c of less than 7% and that high-risk individuals consult individually with their health care providers.
Intensive control of glucose reduced the incidence of nephropathy in patients with type 2 diabetes but showed no significant effect on other vascular outcomes, according to new results from the ADVANCE trial.
The newly approved OneTouch Ping Glucose Management System allows patients to calculate and deliver insulin doses without touching their pumps.
A recent large study found that poor glucose control was associated with a fourfold increase in mortality and major complications following cardiac surgery, regardless of whether patients had been diagnosed with diabetes.
Tight glucose control may not improve outcomes in critically ill patients and may increase rates of hypoglycemia, according to a new study.
Current guidelines from the American Diabetes Association and other groups recommend tight control of glucose levels in critically ill patients. This recommendation is based mainly on a 2001 trial reporting a one-third reduction in mortality with tight glucose control in surgical ICU patients, but more recent trials in additional settings have yielded mixed results. To find a more definitive answer, the current researchers performed a meta-analysis of the risks and benefits of glucose control in the critically ill.
Tight glucose control improves the cardiovascular risk of patients with type 2 diabetes years after intensive therapy is discontinued, a new study found.
Researchers looked at follow-up data from the United Kingdom Prospective Diabetes Study, in which 4,209 newly diagnosed patients were randomly assigned either conventional diabetes therapy (dietary restriction) or intensive therapy (either sulfonylurea or insulin or, in overweight patients, metformin). After the trial was concluded, 3,277 of the patients were followed over the next 10 years. The results were published in the Sept. 10 online New England Journal of Medicine.
One year after the study, differences between the groups in glycated hemoglobin levels had disappeared. However, after 10 years, the sulfonylurea-insulin group still had a 9% risk reduction in all diabetes-related end points, 24% lower rates of microvascular disease, and 15% and 13% reductions in myocardial infarction and death from any cause, respectively. The metformin group had even more dramatic differences, with 21% lower diabetes-related end points, 33% lower MI, and 27% less death from any cause.
The results of this study, which included more than 66,000 person-years of follow-up, indicate that the "legacy effect" of intensive glucose lowering is longer than has been previously reported, the authors concluded. The findings highlight the importance of glucose lowering (in addition to lipid-lowering and antihypertensive therapy) in reducing the risk of coronary events and death for patients with type 2 diabetes, they said.
I spent today at an Internal Medicine 2009 precourse on diabetes and picked up a lot of miscellaneous interesting info, particularly during the session by Irl Hirsch, FACP, on monitoring in diabetes. Most common reason that patients' finger-sticks are inaccurate? They don't wash their hands beforehand. If you eat an orange, then test blood from one of your sticky fingers, the glucose from the fruit could make the result inaccurately high. But should your type 2 patients who aren't on insulin even be bothering to self-monitor? Given that there's no proof that home testing affects outcomes and test strips are expensive, Dr. Hirsch sees the main use being special occasions, like when a patient is eating something new and wants to see how her blood sugar responds. A1cs are good, but not perfect. Anemia, in particular, can make their results inaccurate. Also, did you know that half of an A1c result is determined by glucose levels over the previous 30 days? The newest big thing in diabetes monitoring--real-time continuous glucose monitors. They work great (i.e., significantly lower A1cs) if patients wear them all the time and pay attention to them, Dr. Hirsch said. Best used by patients and physicians who are tech-savvy and willing to devote some real time and attention. The next big thing, however, could turn out to be a very old thing--urine glucose testing. If a currently underway study proves that it's as effective as home blood testing, payers could push for a move back to the older, cheaper option. In the afternoon, David Kendall, MD, made a convincing case for incretin-based therapies. In addition to improving insulin secretion and response, the drugs reduce food intake and cause weight loss. So how to decide if exentide and the other on-their-way-to-market options in the class are right for your patients? That was a little fuzzier--"you'll know 'em when you see 'em" was the gist of his message. (Posted by Stacey Butterfield)
The U.S. Food and Drug Administration today approved a device that measures glucose levels continuously for up to seven days in people with diabetes. While a standard fingerstick test records a person's glucose level as a snapshot in time, the STS-7 Continuous Glucose Monitoring System (STS-7 System) measures glucose levels every five minutes throughout a seven-day period. This additional information can be used to detect trends and track patterns in glucose levels throughout the week that wouldn't be captured by fingerstick measurements alone. However, diabetics must still rely on the fingerstick test to decide whether additional insulin is needed.
The hemoglobin A1C (A1C) test can lead to false outcomes resulting in over-treatment or under-treatment of diabetes in people with inherited hemoglobin variants, also called hemoglobinopathies. Hemoglobin S and E are prevalent variants in people of African, Mediterranean, or Southeast Asian descent. These variants interfere with some A1C tests--both laboratory and point-of-care tests. If A1C tests are at odds with blood glucose monitoring results, interference should be considered. Reliable A1C tests, in which hemoglobin variants do not cause interference, are available. More information is available at www.ngsp.org, the National Glycohemoglobin Standardization Program. A1C should be measured at least twice annually to assess control of diabetes but should not be used to diagnose diabetes.
A new information campaign of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, highlights the importance of using accurate methods to test hemoglobin A1c in people with diabetes who have sickle cell trait or other inherited forms of variant hemoglobin. The specific needs for testing blood glucose control in these patients are explained in two booklets, "Sickle Cell Trait and Other Hemoglobinopathies and Diabetes: Important Information for Physicians" and "For People of African, Mediterranean, or Southeast Asian Heritage: Important Information about Diabetes Blood Tests" from NIDDK's National Diabetes Information Clearinghouse at: www.diabetes.niddk.nih.gov.
The ADA has issued their 2008 Comprehensive Guidelines for Diabetes Care
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