Table 1

Recommended basic outcome measures to be reported for AP clinical trials

Comments
Glycemic metrics*,
 HbA1cIf intervention period ≥3 months
 Mean CGM glucose
 % CGM time <50 mg/dL (<2.8 mmol/L)
 % CGM time <60 mg/dL (<3.3 mmol/L)
 % CGM time <70 mg/dL (<3.9 mmol/L)
 % CGM time 70–140 mg/dL (3.9–7.8 mmol/L)
 % CGM time 70–180 mg/dL (3.9–10.0 mmol/L)
 % CGM time >180 mg/dL (>10.0 mmol/L)
 % CGM time >250 mg/dL (>13.9 mmol/L)
 % CGM time >300 mg/dL (>16.7 mmol/L)
 SD and coefficient of variation of CGM valuesSD is much more dependent on the mean than coefficient of variation
 Fasting blood glucose, mg/dL (mmol/L)If available, depending on study design; CGM glucose at 06:00 can be taken as proxy
Safety metrics
 SH eventsAs defined by ADA (adults) (32) and ISPAD (children and adolescents) (31)
 Diabetic ketoacidosis eventsPer ADA definition (41)
Technical performance metrics*
 % Time closed-loop active
 Total daily dose of insulin
 Total daily dose of glucagon or other hormonesIf applicable
  • ADA, American Diabetes Association; ISPAD, International Society for Pediatric and Adolescent Diabetes.

  • * Metrics may have a skewed distribution. Report median (quartiles) instead of mean if not normally distributed.

  • All CGM measures should be reported for the overall 24-h period (if applicable) and also stratified by daytime and nighttime periods. The time period 00:00 to 06:00 is proposed as a definition of the nighttime period to exclude postprandial data as much as possible for a typical study population, though this definition may not be appropriate for all studies.