Table 2.

Schedule depicting the enrollment and interventions for the Diactive-1 Study in accordance with the SPIRIT 2013 guidelines ²⁶.

TIMEPOINT	STUDY PERIOD
	Enrolment	Allocation		Post-allocation
	-t1	0	Baseline (T0)	T1 (12 weeks)	T2 (24 weeks)
ENROLMENT:
Eligibility screen	X
Informed consent	X
Allocation		X
INTERVENTIONS:
Diactive-1		X
Waiting-list control group		X
ASSESSMENTS:
Daily insulin dosage requirement			X	X	X
Glycemic control (time in range, glucose coefficient of variation, number of hypoglycemic and hyperglycemic events)			X		X
Cardiovascular biomarkers (of fasting glucose, glycated hemoglobin, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoproteins, alanine aminotransferase, and aspartate aminotransferase)			X		X
Anthropometric parameters (body weight, standing and sitting height)			X		X
Sexual maturation and peak height velocity			X		X
Body composition parameters (total body fat, lean mass, subcutaneous and visceral adiposity, bone mineral content and density)			X	X	X
Heart rate variability			X		X
Vascular function			X		X
Physical fitness components (cardiorespiratory and muscular fitness)*			X	X	X
Physical activity, sedentary time, and sleep duration by accelerometers and questionnaires *			X	X	X
Sleep quality			X		X
Inadvertent hypoglycemia			X		X
Psychological assessments (Health-Related Quality of Life and subjective well-being)			X		X
Diet (adherence to the Mediterranean diet and food consumption)			X		X
Eating disorders			X		X
App usability					X

* It will only evaluate handgrip strength and accelerometer-based physical activity at 12-week mark.

T, represents a time-point.