Type 1 Diabetes
Conditions
Interventions
experimental group:FreeStyle Libre Flash Glucose Monitoring
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1)Signed ICFt. 2)Male or female, aged 18 years and above at the time of signing informed consent; 3)Diagnosed with T1DM; 4)18.5kg/m2=BMI=35kg/m2; 5)Insulin therapy including insulin pump and/or multiple daily insulin injections (at least 2 injections daily) for =3 months; 6)In all study visits, maintain a normal medication plan.
Exclusion criteria
Exclusion criteria: 1)Subject has used Previous Freestyle Libre Flash Glucose Monitoring System within 3 months prior to the beginning of the study activities. 2)Subject is using sensor-enhanced insulin pump therapy. 3)Subject has known allergy to medical grade adhesive. 4)Subject is pregnant, attempting to conceive or lactating women. 5)Subject is taking or has taken oral or intravenous glucocorticoids during the study. 6)Subjects is taking vitamin C (=60mg)or aspirin daily. 7)Subjects is at honeymoon period. 8)Subjects is unwilling to conduct self-glycemia monitoring as required by the study protocol. 9)Subject fails to record diet and exercise with smartphone. 10)Subject has diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome(HHS) within 3 months prior to the beginning of the study activities. 11)Subject has acute myocardial infarction within 3 months prior to the beginning of the study activities. 12)Subject is anemic, defined as having hemoglobin levels less than 110 g/dL for females and less than 120 g/dL for males. 13)Subject has received blood within 3 months prior to the beginning of the study activities. 14)Impaired hepatic function(ALT or AST is more than 3 times the upper limit of normal, and TBIL is more than 2 times above the upper limit of normal.) 15)Severe renal impairment (estimated GFR <30ml/min) 16)Proliferative diabetic retinopathySubject has surgical or laser treatment of proliferative diabetic retinopathy or macular degeneration within 6 months prior to the beginning of the study activitiesor attending to treat other unstable retinopathy with surgical or laser during the study duration. 17)Subject has malignant tumor. 18)Subject has mental disorder. 19)Subject has current or recent history of alcohol or drug abuse. 20)Subject has MRI appointment scheduled during the period of study participation. 21)Subject is unsuitable for participation due to serious systemic diseases as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coefficient of variation of blood glucose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c;Standard deviation of glucose;Mean amplitude of glycemic excursions;Coefficient of variation of blood glucose;Largest amplitude of glycemic excursions;Mean of daily differences;Blood glucose risk index;Low blood glucose index;Continuous overall net glycemic action;Time in Range;Time in Hyperglycaemia;Time in Hypoglycemia;Frequency in hypoglycemia;The area under the curve of hypoglycemia;Total daily dose of insulin;Body Mass Index;Daily calorie;Daily exercise;Chinese version Scale of the Diabetes Self-care Activities;The Diabetes Distress Scale;Hypoglycaemia Fear Scale;Hypoglycemic Confidence Scale; | — |
Countries
China
Contacts
Public ContactGuo Lixin
Beijing Hospital
Outcome results
None listed