AACE and ACE Consensus Statement on Glucose Monitoring
AACE and ACE Consensus Statement on Glucose Monitoring
Several modern studies have demonstrated the importance of glucose control to reduce both short- and long-term complications. One of the major tools to improve glycemic control is GM. With the advancement of technology, many meters are now available that allow SMBG throughout the day. We now have advanced technology that allows CGM. Emergent technology now enables GM to interface with insulin administration. Although experts favor frequent GM in most patients with diabetes, many insurance payers, including the CMS, deny appropriate monitoring access due to the cost of possibly an open-ended policy. Understanding the need to form consensus on these issues, participant experts evaluated the available evidence to support GM in people with diabetes.
Consensus participants emphasized that GM is only reasonable if it is actionable. Most major diabetes studies have focused on the long-term outcomes of glucose control, in particular micro- and macrovascular disease. However, an equally important aspect of diabetes care involves prevention of short-term complications, including hypoglycemia and diabetic ketoacidosis (DKA). Available data support GM, CGM, and advanced technologies to reduce and prevent hypoglycemia. Management plans should be developed by the patient and their diabetes clinician to optimize glucose control and should be based on individual patient preferences and lifestyle. Isolated studies have failed to demonstrate value for GM in achieving glucose control due to poor design and a lack of clinical intervention related to results of GM. More recent trials using structured GM coupled with clinical decision-making demonstrate clear-cut benefits in improving glucose control.
One of the most commonly used measures to monitor glucose control is glycated hemoglobin (A1c). However, in a large subgroup of people with diabetes, an estimated 15% of A1c values might be misleading. Specifically, certain ethnic groups, people with sickle cell anemia, and patients with severe kidney disease have A1c levels that do not correlate with average glycemia. Additionally, in patients with widely variable glucose levels, the A1c will not provide a true picture of detrimental recurrent hypoand hyperglycemic episodes. For these patients, frequent GM or continuous GM is virtually the only way to assess glucose control over time.
Participant experts suggested engaged people with type 1 diabetes should perform GM at least 8 times daily. The American Diabetes Association recommends that patients on intensive insulin regimens conduct self-monitoring of blood glucose (SMBG) prior to meals and snacks, occasionally postprandially, at bedtime, prior to exercise, when they suspect low blood glucose, after treating low blood glucose, and prior to critical tasks (e.g., driving). Frequent GM reduces frequency of hypoglycemia. In a study of people with type 1 diabetes, increased frequency of GM decreased mean A1c across all age groups. Although there was no upper limit to the frequency of daily monitoring that offered the most benefit to A1c control, the effect appears to begin to plateau around 7 to 8 times per day.
Epidemiologic observational data indicate that SMBG correlates with decreased diabetes-related complications and with all-cause mortality in people with type 2 diabetes. Patients with type 2 diabetes and high hypoglycemia risk such as those on multiple daily injections (MDI) of insulin should have glucose monitored at frequency similar to patients with type 1 diabetes. In addition, people with type 2 diabetes who are treated with medications that can cause hypoglycemia (e.g., basal insulin and sulfonylurea), especially the elderly, are more prone to hypoglycemia and should have more frequent monitoring. Although there is a lack of robust data, the consensus of expert opinion suggested GM from 3 to 5 times per day in this population. Because controlled trials in people with type 2 diabetes managed with lifestyle modification or medications with low risk of hypoglycemia are lacking, participant expert opinion suggested that such patients should monitor glucose as clinically indicated, from 1 to 4 times per day.
Experts suggested that pregnant, insulin-treated patients should monitor their glucose at least 8 times daily, while those managed with lifestyle modifications or low-hypoglycemia risk medications need less frequent monitoring, perhaps 4 to 6 times per day. Large, randomized trials are needed to validate these expert clinical opinions.
There was considerable discussion about the frequency of GM in all patient populations, but the consensus was that clinical usage must be driven by clinician-patient collaborative agreement on the optimal level of GM.
CGM usage has improved clinical diabetes outcomes by reducing hypoglycemia. CGM is recommended in all patients with type 1 diabetes and should be available to all type 2 diabetes on multiple insulin injections, basal insulin, or sulfonylureas. CGM should also be used in all patients who are at risk for hypoglycemia and/or have hypoglycemia unawareness.
While studies using CGM in type 2 diabetes are limited, experts in clinical practice realize that it can be useful in identifying and correcting postprandial glycemic excursions. It was the participant expert opinion that intermittent use of CGM (usually 1–2 weeks) in patients with type 2 diabetes might be more effective than daily glucose fasting glucose in guiding the need for medication adjustment or advancing to new medications.
The existing data indicate that accuracy of GM correlates with increased patient confidence in using GM devices, resulting in better adherence, more confident insulin adjustments, and improved quality of life. Recognizing this fact, participants expressed a concern that increased accuracy may affect upfront cost and lead insurers to view accurate GM as cost prohibitive. The participant experts identified the 2013 ISO standards for accuracy, precision, and bias as a step in the right direction, with the realization that the standard applied at low glucose levels may need to be more stringent to avoid clinically inappropriate decisions. Participants also noted that values that are far out of range are more problematic than inherent meter bias, as these can affect immediate decision making if confirmatory testing is not performed. In particular, the importance of errors in or around the hypoglycemic range was emphasized.
I. GM and Complications
Several modern studies have demonstrated the importance of glucose control to reduce both short- and long-term complications. One of the major tools to improve glycemic control is GM. With the advancement of technology, many meters are now available that allow SMBG throughout the day. We now have advanced technology that allows CGM. Emergent technology now enables GM to interface with insulin administration. Although experts favor frequent GM in most patients with diabetes, many insurance payers, including the CMS, deny appropriate monitoring access due to the cost of possibly an open-ended policy. Understanding the need to form consensus on these issues, participant experts evaluated the available evidence to support GM in people with diabetes.
Consensus participants emphasized that GM is only reasonable if it is actionable. Most major diabetes studies have focused on the long-term outcomes of glucose control, in particular micro- and macrovascular disease. However, an equally important aspect of diabetes care involves prevention of short-term complications, including hypoglycemia and diabetic ketoacidosis (DKA). Available data support GM, CGM, and advanced technologies to reduce and prevent hypoglycemia. Management plans should be developed by the patient and their diabetes clinician to optimize glucose control and should be based on individual patient preferences and lifestyle. Isolated studies have failed to demonstrate value for GM in achieving glucose control due to poor design and a lack of clinical intervention related to results of GM. More recent trials using structured GM coupled with clinical decision-making demonstrate clear-cut benefits in improving glucose control.
One of the most commonly used measures to monitor glucose control is glycated hemoglobin (A1c). However, in a large subgroup of people with diabetes, an estimated 15% of A1c values might be misleading. Specifically, certain ethnic groups, people with sickle cell anemia, and patients with severe kidney disease have A1c levels that do not correlate with average glycemia. Additionally, in patients with widely variable glucose levels, the A1c will not provide a true picture of detrimental recurrent hypoand hyperglycemic episodes. For these patients, frequent GM or continuous GM is virtually the only way to assess glucose control over time.
Frequency
Participant experts suggested engaged people with type 1 diabetes should perform GM at least 8 times daily. The American Diabetes Association recommends that patients on intensive insulin regimens conduct self-monitoring of blood glucose (SMBG) prior to meals and snacks, occasionally postprandially, at bedtime, prior to exercise, when they suspect low blood glucose, after treating low blood glucose, and prior to critical tasks (e.g., driving). Frequent GM reduces frequency of hypoglycemia. In a study of people with type 1 diabetes, increased frequency of GM decreased mean A1c across all age groups. Although there was no upper limit to the frequency of daily monitoring that offered the most benefit to A1c control, the effect appears to begin to plateau around 7 to 8 times per day.
Epidemiologic observational data indicate that SMBG correlates with decreased diabetes-related complications and with all-cause mortality in people with type 2 diabetes. Patients with type 2 diabetes and high hypoglycemia risk such as those on multiple daily injections (MDI) of insulin should have glucose monitored at frequency similar to patients with type 1 diabetes. In addition, people with type 2 diabetes who are treated with medications that can cause hypoglycemia (e.g., basal insulin and sulfonylurea), especially the elderly, are more prone to hypoglycemia and should have more frequent monitoring. Although there is a lack of robust data, the consensus of expert opinion suggested GM from 3 to 5 times per day in this population. Because controlled trials in people with type 2 diabetes managed with lifestyle modification or medications with low risk of hypoglycemia are lacking, participant expert opinion suggested that such patients should monitor glucose as clinically indicated, from 1 to 4 times per day.
Experts suggested that pregnant, insulin-treated patients should monitor their glucose at least 8 times daily, while those managed with lifestyle modifications or low-hypoglycemia risk medications need less frequent monitoring, perhaps 4 to 6 times per day. Large, randomized trials are needed to validate these expert clinical opinions.
There was considerable discussion about the frequency of GM in all patient populations, but the consensus was that clinical usage must be driven by clinician-patient collaborative agreement on the optimal level of GM.
CGM
CGM usage has improved clinical diabetes outcomes by reducing hypoglycemia. CGM is recommended in all patients with type 1 diabetes and should be available to all type 2 diabetes on multiple insulin injections, basal insulin, or sulfonylureas. CGM should also be used in all patients who are at risk for hypoglycemia and/or have hypoglycemia unawareness.
While studies using CGM in type 2 diabetes are limited, experts in clinical practice realize that it can be useful in identifying and correcting postprandial glycemic excursions. It was the participant expert opinion that intermittent use of CGM (usually 1–2 weeks) in patients with type 2 diabetes might be more effective than daily glucose fasting glucose in guiding the need for medication adjustment or advancing to new medications.
Accuracy
The existing data indicate that accuracy of GM correlates with increased patient confidence in using GM devices, resulting in better adherence, more confident insulin adjustments, and improved quality of life. Recognizing this fact, participants expressed a concern that increased accuracy may affect upfront cost and lead insurers to view accurate GM as cost prohibitive. The participant experts identified the 2013 ISO standards for accuracy, precision, and bias as a step in the right direction, with the realization that the standard applied at low glucose levels may need to be more stringent to avoid clinically inappropriate decisions. Participants also noted that values that are far out of range are more problematic than inherent meter bias, as these can affect immediate decision making if confirmatory testing is not performed. In particular, the importance of errors in or around the hypoglycemic range was emphasized.