Study design and participants
T1D, diabetic retinopathy, death, allergy
DIABETIC RETINOPATHY, SYSTEMIC DISEASE, ADVERSE EVENTS, TYPE 1 DIABETES, ALLERGY, MACULAR EDEMA
Adults with T1D were consecutively recruited for this 12-week, multi-center, prospective, 2:1 randomized controlled trial (Study flow in a study of the efficacy of unblinded and blinded intermittently flash continuous glucose monitoring on glycemic control in adults with type 1 diabetes.The major eligibility criteria were clinical diagnosis of T1D, age ≥18 years, use of insulin therapy, and no use of CGM in the 3 months prior to enrollment. Willingness to participate in a 2-week screening period and use the blinded isCGM system were other inclusion criteria. In addition, the individual was required to perform SMBG at least four times a day (before every meal and before sleeping) with the blinded isCGM device.The exclusion criteria were current or previous use of CGM or sensor-enhanced insulin pump therapy; known allergy to medical-grade adhesive; adverse events that endanger life or could cause death and serious systemic diseases; known severe diabetic retinopathy and/or macular edema; lactation, pregnancy, or intention to become pregnant during the study; presence of any condition that is likely to require MRI; use of medication containing acetaminophen or vitamin C; and unwillingness to use the study device.During the study period, all the patients were free to use unblinded isCGM real-time glucose values or SMBG to adjust their diet, physical activity, and insulin therapy. All participating centers provided ethical approval for the study prior to its commencement, and all the participants provided their written informed consent.