Table 1

Primary and secondary outcomes

Outcome hierarchyMeasurement classMeasurement type (source)Outcome measure
Primary outcomeGlycemic controlGlycemic variability (CGM)• CV CGM
Secondary outcomesGlycemic variabilityGlycemic variability (CGM)• SD in glucose levels
• MAGE
• CONGA
• MODD
Other glycemic indices• % glucose within 71–180 mg/dL by CGM
• Hypoglycemia (clinical)
BiomarkersSystemic inflammation (serum)• IL-6
• CRP
• SAA
Oxidative stress (urine)• 8-iso-PGF2α
Diabetic kidney disease (urine)• Albumin/creatinine ratio
Weight controlBody weight (vital signs)• Body weight
• BMI
Rhythm disturbanceArrhythmias (Holter monitor)• QTc
 By randomized group
• Arrhythmias
 By randomized group:
  Supraventricular arrhythmias
  Ventricular arrhythmias
Tertiary outcomesGlycemiaHyperglycemia (serum)• 1,5-AG
Adipocyte biologyAdipokine (serum)• Adiponectin
Plasma lipoproteinHDL proteins (plasma)• HDL proteomics
Systemic metabolismMetabolites (serum)• Metabolomics