Effect of 6 months’ flash glucose monitoring in adolescents and young adults with type 1 diabetes and suboptimal glycaemic control: managing diabetes in a ‘flash’ randomised controlled trial protocol

Table 2 Managing Diabetes in a ‘Flash’ schedule of assessments

	Time point
Outcome	Baseline	3 m	6 m	9 m^a	12 m^a
Adverse events
Cutaneous, diabetic ketoacidosis, severe hypoglycaemia	Every 2 weeks from baseline
Device performance
FGM/SMBG device malfunctions, FGM sensor failures	Every 2 weeks from baseline
Clinical
Glycaemic control	X	X	X	X	X
Height	X	X	X	X	X
Weight	X	X	X	X	X
Glucose monitoring behaviour
Blood glucose monitoring	X	X	X	X	X
Interstitial glucose monitoring		X	X	X	X
Habitual sleep and physical activity
Sleep	X	X	X
Physical activity	X	X	X
Participant reported
Diabetes treatment satisfaction	X	X	X		X
Fear of hypoglycaemia	X	X	X		X
Flash glucose monitoring acceptability		X	X		X
Health-related quality of life (generic)	X	X	X		X
Health-related quality of life (diabetes-specific)	X	X	X		X
Sleep quality and quantity	X	X	X		X

^a Denotes continuation phase of study
Abbreviations: FGM Flash glucose monitoring, SMBG self-monitoring blood glucose

ISSN: 1472-6823