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This article has been cited by other articles in PMC. Abstract Measurement of glycated hemoglobin HbA 1c has been the traditional method for assessing glycemic control. Introduction Glucose measurements are critical to effective diabetes management. CGM data should be used to assess hypoglycemia and glucose variability. Recommendations CGM should be considered in conjunction with HbA 1c for glycemic status assessment and therapy adjustment in all patients with type 1 diabetes and patients with type 2 diabetes treated with intensive insulin therapy who are not achieving glucose targets, especially if the patient is experiencing problematic hypoglycemia.
Structured testing regimens should be defined for patients when SMBG is prescribed. Recommendation Only CGM systems that provide an acceptable level of sensor accuracy should be used. Definition and Assessment of Hypoglycemia in Clinical Studies Key Findings Hypoglycemia remains a major barrier for glycemic control and a common complication of diabetes treatment, especially in type 1 diabetes 51 [ E ]. Recommendations The definition of hypoglycemia should take into consideration several parameters: the compartment of measurement arterial, venous, and capillary blood or interstitial , the nadir level of blood glucose measured, and the duration of the event and related symptoms.
Hypoglycemia should be quantified in the following ways. A hypoglycemic event should be defined as follows. LBGI should be reviewed when assessing hypoglycemia risk. Assessment of Glycemic Variability Key Findings Numerous studies have focused on glycemic variability as an independent risk factor for diabetes complications, particularly cardiovascular disease 60 — 63 [ C,E,C,C ], and on the effects of glycemic variability on cognitive function and quality of life 64 [ C ].
Recommendations Glycemic variability evaluated from CGM data should be considered among other factors of the overall clinical representation of glycemic control. Composite Measures Because the function of CGM use is to monitor glucose levels with the ultimate goal of improving glycemic control, it makes clinical sense to combine TIRs data with other measures.
Recommendations Percentages of time in ranges target, hypoglycemia, and hyperglycemia should be assessed and reported. Visualization, Analysis, and Documentation of Key CGM Metrics Key Findings Standardizing glucose reporting and analysis similar to electrocardiogram output is vital to optimizing clinical decision-making in diabetes.
Mean glucose. Glycemic variability, reported as CV primary and SD secondary. Data sufficiency: minimum 2 weeks of data.
Table 1 Key metrics for CGM data analysis and reporting. Open in a separate window. However, these conditions are included in the table because they are important clinical categories that must be assessed and documented.
Figure 1. Conclusions CGM is a robust research tool, and continuous glucose data should be recognized by governing bodies as a valuable and meaningful end point to be used in clinical trials of new drugs and devices for diabetes treatment.
Supplementary Material Supplementary Data: Click here to view. Article Information Acknowledgments. References 1. Structured self-monitoring of blood glucose reduces glycated hemoglobin in insulin-treated diabetes.
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Email alerts. Article Text. Article menu. Short report. Consensus outcome rating for international neonatal resuscitation guidelines. Statistics from Altmetric. Competing interests None declared. Patient consent for publication Not required.
No commercial re-use. See rights and permissions. A major barrier to improving care effectiveness for mental health is a lack of consensus on outcomes measurement. This Position Paper reports on recommendations specifically for anxiety, depression, obsessive-compulsive disorder, and post-traumatic stress disorder in children and young people aged between 6 and 24 years.
An international ICHOM working group of 27 clinical, research, and lived experience experts formed a consensus through teleconferences, an exercise using an adapted Delphi technique a method for reaching group consensus , and iterative anonymous voting, supported by sequential research inputs.
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