Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to assess the effect of FGM on glycemic control compared with SMBG using a randomised controlled study design in adults with type 2 diabetes.
Flash glucose monitoring (FGM) is a newly introduced Glucose Monitoring system. The aim of the study is to assess the effect of FGM on glycemic control compared with standard blood glucose monitoring (SMBG) using a randomised controlled study design in adults with type 2 diabetes. Subjects will use unmasked FGM once a month or SMBG to monitor glucose level for 3 months. Patients in the SMBG group will wear masked FGM to collect glycaemic variability data for comparison to the intervention group of the study. The primary outcome, HbA1c, will be cpmpared at baseline and 3 month. Glucose control parameters provided by unmasked and masked FGM will be compared in the two groups, including mean blood glucose (MBG), coefficient of variation (CV), area under the curve (AUC), Time in Range(TIR), etc.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FGM group | Experimental | Diabetic patients will use FreeStyle Libre Flash Glucose Monitoring (FGM) system(unmasked) to monitor glucose level once a month for 3 months. |
|
| SMBG group | No Intervention | Diabetic patients will use Standard Blood Glucose Monitoring (SMBG) to monitor glucose level for 3 months. A 14-day masked wear of FreeStyle Libre H Flash Glucose Monitoring system is included for these subjects once a month, to collect glycaemic variability data for comparison to the intervention group of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freestyle Libre Flash Glucose Monitoring | Device | Freestyle Libre Flash Glucose Monitoring will be used in diabetic patients once a month for therr months to monitor glucose level. Patients could scan the sensor to get the glucose level at any time as they want. They could alter thier diet and exercise according to the glucose levels. Patients will be required to keep track of food and exercise during wearing FGM sensor. Physicians would adjust patients' medication according their glucose profile provided by FGM, A1c, and diet and exercise every month. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Difference in HbA1c between intervention and control group at 3 month adjusting for baseline HbA1c | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| mean blood glucose (MBG) | Difference in HbA1c between intervention and control group at 1, 2, and 3 month. | 1,2,3 months |
| coefficient of variation (CV) | Difference in CV between intervention and control group at 1, 2, and 3 month. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ma Jianhua, MD | Contact | 8625-52887092 | majianhua196503@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ma Jianhua, MD | The First Affiliated Hospital with Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hostital | Recruiting | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32858752 | Derived | Chen M, Li H, Shen Y, Liu B, Yan R, Sun X, Ye L, Lee KO, Ma J, Su X. Flash Glucose Monitoring Improves Glucose Control in People with Type 2 Diabetes Mellitus Receiving Anti-diabetic Drug Medication. Exp Clin Endocrinol Diabetes. 2021 Dec;129(12):857-863. doi: 10.1055/a-0994-9850. Epub 2020 Aug 28. | |
| 32696267 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 1,2,3 months |
| area under the curve (AUC)<3.9mmol/L and >10mmol/L | Difference in AUC<3.9mmol/L and >10mmol/L between intervention and control group at 1, 2, and 3 month. | 1,2,3 months |
| Time in Range (TIR) | Difference in time in range 3.9-10 mmol/L between intervention and control group at 1, 2, and 3 month. | 1,2,3 months |
| FGM accuracy | Accuracy of FGM values versus reference blood glucose values (Consensus Error Grid (CEG) analysis and calculation of the Mean Absolute Relative Difference (MARD) | during FGM |
| Hu Y, Shen Y, Yan R, Li F, Ding B, Wang H, Su X, Ma J. Relationship Between Estimated Glycosylated Hemoglobin Using Flash Glucose Monitoring and Actual Measured Glycosylated Hemoglobin in a Chinese Population. Diabetes Ther. 2020 Sep;11(9):2019-2027. doi: 10.1007/s13300-020-00879-x. Epub 2020 Jul 21. |