Table 1.

Patient flow of enrolment, intervention and outcome measurements.

		PS	M0	M3	M6	M9	M12
Enrolment	Recruitment	×
	Eligibility Screening	×
	Informed consent	×
	Allocation		×
Intervention	Insulin injection	•					•
	Experimental drugs / placebo		•	•
Outcomes	Demographic characteristics (Age, sex, nationality, occupation, marital status, residence and education level)		×
	Anthropometric variables (BMI, waist and hip circumference, heart rate and blood pressure)	•					•
	Insulin logs		•				•
	Dietary logs		•				•
	CGMS*		•				•
	Metabolic parameters (HbA1C, FBG, PBG, FCP, 2hCP, Triglyceride, Total cholesterol, HDL cholesterol, LDL cholesterol)	•					•
	HOMA-IR**		•				•
	Insulin autoantibody (GADA, IA2A, ZnT8)	×	×	×			×
	Serum inflammation markers		×	×
	Chronic complication screening (Carotid ultrasound, UCG, fundus examination, urinary albumin-creatinine ratio, eGFR)		×				×
	Gut microbiota (Metagenomics, stool metabolomics, plasma metabolomics)		×	×			×
	Intestinal permeability		×	×			×
	Drug safety assessment (Blood routine, Liver and kidney function testing, Serum electrolytes, Blood ketones, electrocardiogram)		×	×
	Quality of Life Questionnaire***		×	×			×
	Adverse events record (hypoglycemic events and drug-related side effects)		×	×

PS, prior to study; M0, baseline assessment; M3, 3 months from the baseline; M6, 6 months from the baseline; M9, 9 months from the baseline; M12, 12 months from the baseline. *CGMS, continuous glucose monitoring system; **HOMA-IR, homoeostasis model assessment index for assessing insulin resistance; ***questionnaire: CN-ADDQoL.