Table 3.

Summary of Recommendations on Reporting of Continuous Glucose Monitoring Methods and Results When Used in Clinical Trials

Article Section	Information domain	Example of detail
Introduction	Purpose of CGM in study	Secondary endpoints, hypoglycemia detail
Methods	Make and version of CGM technology	Manufacturer; read-out system
		Calibration methodology
		Criteria for successful use in the individual
	Setting of CGM utilization	Inpatient or ambulatory care
		Education to participants and investigators
		Injection therapy and dose algorithms; meal-time dose calculator; open-loop pump; closed-loop functions
		Real time or blinded
		Duration/timing of implementation
	Classic glucose control data	Including HbA1c, prebreakfast SMPG, hypoglycemia incidence and event rates, and status of these outcomes in results hierarchy
	Data analysis	Use of any averaging function
		Statistical outputs such as time in range and area above and below cutoffs; other outputs
		Parameters of glucose variability and how they are calculated
		Whether outputs are primary, secondary, or observational/safety
		Definitions and standards of hypoglycemia used
Results	Methodological	Percent of participants with successful CGM implementation, duration of implementation
		Deviation between CGM and SMPG calibration measurements
		Use of CGM in dose or therapy changes
	Classic glucose control outcomes	See Methods above
	CGM outcomes	Time in/out of range, and area/average glucose out of range high and low separately using default cutoffs of 140 and 70 mg/dL
		Similar data using cutoffs of investigator choice appropriate to study question and technology under investigation
		CGM-based hypoglycemia data by time of day as appropriate to study, and to include glucose nadirs and presence or absence of symptoms during low excursions
		Within-patient, within-day glucose variability, and between-day (average day), within-patient variability. Such other within-patient variability for defined time periods (e.g., night or prebreakfast) as predetermined and appropriate to study
Discussion		Impact of CGM findings on study findings using conventional measures
		Generalizability of findings to people not using CGM (if real-time and dose/therapy adjustment utilized)
		Limitations of CGM: extent of usable data, calibration findings, extreme glucose excursions