ChiCTR2000032703.

Methods	Allocation: randomised Intervention model: cross‐over study Masking: not stated Primary purpose: treatment
Participants	Condition: T1DM Estimated number of participants: 20 Inclusion criteria: 1. At the time of screening, the age of patients >= 18 years old; both male and female considered; 2. Participants who were all type 1 diabetic patients, with the serum C‐peptide concentration confirmed as low level (< 0.07 nmol/L) at least twice; 3. Participants who had been continuously using the basic plus meal insulin treatment scheme in the past 3 months; 4. Patients with HbA1c meeting the standard: 6.9% <= HbAlc <= 10.0%; 5. Body mass index (BMI) of 18.0‐35.0kg/m2; 6. Patients who could understand and abide by the test process, voluntarily participate in the test and provide informed consent. Exclusion criteria: 1. Patients with diabetic ketoacidosis or diabetic hyperosmotic nonketotic coma in the past 6 months; 2. Patients with severe infection, surgery or severe trauma in the past month; 3. Patients with any of the following history and conditions of heart disease in the past 6 months: (1) Decompensated cardiac insufficiency (NYHA grade III or IV) (2) Unstable angina, myocardial infarction, coronary artery bypass grafting or coronary stent implantation (3) Uncontrolled or serious arrhythmias (such as long QT interval syndrome) according to the evaluation of researchers; 4. Patients with haemorrhagic stroke or ischaemic stroke in the past 6 months as assessed by the researchers; 5. At present, patients with any disease that may cause haemolysis or red blood cell instability and affect the detection of glycosylated haemoglobin; 6. Patients with a history of acute or chronic pancreatitis; 7. Liver function damaged, AST/ALT > 3 times of the upper limit of reference range, total bilirubin > 1.5 times of the upper limit of reference range; 8. Renal insufficiency, glomerular filtration rate (EGFR) < 60 mL/min/1.73m2 9. Patients with diseases that may cause tissue hypoxia (especially the deterioration of acute disease or chronic respiratory disease); 10. Patients with severe chronic gastrointestinal diseases with malnutrition, hunger or weakness; 11. Patients with adrenal dysfunction; 12. Patients that were habitual heavy drinkers; 13. Patients with dehydration or gastrointestinal symptoms, such as diarrhoea or vomiting related to dehydration risk; 14. Patients with malignant tumours requiring treatment in the past 5 years; 15. Patients who had received or were receiving any other investigational drug in the past 3 months; 16. Patients with serious mental illness or language disorder who were unwilling or unable to fully understand co‐operation; 17. Patients who were or might be allergic to insulin or similar drugs; 18. Pregnant or lactating women; 19. Patients who had used CGMS system in the past 6 months; 20. Patients who were receiving systemic glucocorticoid treatment (oral and intravenous) due to any disease; 21. Patients taking vitamin C and aspirin with daily dose greater than 60 mg; 22. Honeymoon patients with type 1 diabetes; 23. Patients known to be allergic to medical grade glue; 24. Where the researchers believed that the participants had other important diseases that were not suitable for the study.
Interventions	Intervention: glargine Comparator: degludec Duration of the intervention: unclear
Outcomes	Primary outcome(s): 24‐h mean glucose levels (SD, coefficient of variation), mean (largest) amplitude of glycaemic excursions, mean of daily difference, time in hypoglycaemia (< 2.8/3.9 mmol/L) during a 24‐h period, time in hyperglycaemia (> 7.8/10.0/13.9 mmol/L) during a 24‐h period; Secondary outcome(s): HbA1c, insulin dose, nocturnal hypoglycaemia, self‐perceived satisfaction rating scale Other outcome(s): — Relevant proposed outcome measures for SoF table: HbA1c, nocturnal hypoglycaemia
Reason for awaiting classification	No publication available. Unclear duration of intervention/follow‐up
Study details	Study identifier: ChiCTR2000032703 Study start date: May 2020 Study completion date: unclear Responsible party/principal investigator: Kuang Hongyu, The First Affiliated Hospital of Harbin Medical University, 23 Post Street, Nangang District, Harbin, Heilongjiang, China
Official title and purpose of study	Comparision of insulin degludec and insulin glargine on blood glucose variability in northern Chinese patients with type 1 diabetes Quote: "To compare blood glucose variability in northern Chinese patients with type 1 diabetes treated with insulin glargine (IGla) versus insulin degludec (IDeg) using flash glucose monitoring (FGM)"
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