Type 1 diabetes mellitus
Conditions
Interventions
Observation group:flash continuous glucose monitoring system, FCGMS
Sponsors
The First Affiliated Hospital of Henan University of Science and Technology
Eligibility
Sex/Gender
All
Age
No minimum to 15 Years
Inclusion criteria
Inclusion criteria: 1. The subject has documented Type 1 Diabetes , as defined by the American Diabetes Association and World Health Organization for at least 1 year prior to study enrollment; 2. The subject used continuous glucose monitoring until 3 months or more before the study started; 3. Aged =14 years; 4. The subject has an HbA1c value =12% at time of screening visit; 5. The subject is willing to follow study instructions
Exclusion criteria
Exclusion criteria: 1. Concomitant diseases that influence metabolic control or other medical condition, which in the Investigator's opinion, may compromise patient safety; 2. Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study; 3. Any significant diseases or conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patient's safety 4. Subject is taking or has taken oral or parenteral glucocorticoids within 1 month prior to screening, or plans to take oral or parenteral glucocorticoids within the planned study duration. Exceptions: Short term oral or parenteral glucocorticoids up to 7 days; 5. Subject has known allergy to medical grade adhesives; 6. Subject is participating in another study of a medical device or drug that could affect glucose measurements or glucose management or receipt of any investigational medical product within 1 month prior to screening; 7. Female subject of child-bearing potential who have a positive pregnancy test at screening, is pregnant, breast-feeding, or planning to become pregnant within the planned study duration or is not using adequate contraceptive methods; 8. Subject diagnosed with current eating disorder such as anorexia or bulimia; 9. Subject has a history of one or more episodes of Diabetes Keto-Acidosis requiring hospitalization within a month prior to screening; 10. Subject has unstable or rapidly progressive renal disease or is receiving dialysis; 11. Subject has active proliferating retinopathy. Subject has current or recent history of alcohol or drug abuse Subject has visual impairment or hearing loss, which in the Investigator's opinion, may compromise patient ability to perform study procedures safely Any disease or condition that may influence the HbA1C testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated Hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target Blood Glucose Range (3.9-7.8 mmol / L) Percentage of time;Target Blood Glucose Range (3.9-7.8 mmol / L) Percentage of time;Higher than the target blood glucose range (> 7.8mmol / L) percentage of time;Low blood glucose (<3.9mmol / L) Percentage of time;Low blood glucose (<3.9mmol / L) Percentage of time;The number of hypoglycemia;Adverse event rate;mean amplitude of glycemic excursion,MAGE;Standard deviation of blood glucose;Diabetes treatment satisfaction score;Hypoglycemia awareness score (Clarke score);Child depression score (CBCL 4/16); | — |
Countries
China
Contacts
Public ContactHongwei Jang
The First Affiliated Hospital of Henan University of Science and Technology
Outcome results
None listed