Super Bolus: a remedy for a high glycemic index meal in children with type 1 diabetes on insulin pump therapy?—study protocol for a randomized controlled trial

Table 1 Timeline of the study

Study period
	Enrollment	Run-in	Allocation	Post-location			Close-out
Time point	0	0	0	Day1	Day 2	Day3	Day 3
Enrollment
Eligibility screen	x
Informed consent	x
Adjusting insulin doses		x
Allocation			x
Interventions
A new infusion set				x
CGM application				x
Super Bolus, Normal Bolus					x	x
Assessments
Anthropometric measurement (body weight, height, BMI)			x
TDD, basal insulin			x
HbA1c			x
Blood glucose level 30, 60, 90, 120, 150, and 180 min after prandial bolus					x	x
Occurrence of hypoglycemia					x	x
Register records from CGM							x
AUC, peak glucose, time to peak, glycemic rise, MAGE							x

Abbreviations: CGM Continuous glucose monitoring system, BMI Body mass index, TDD Total daily dose of insulin, AUC Area under the blood glucose curve, MAGE Mean amplitude of glycemic excursion

ISSN: 1745-6215