Diabetes Mellitus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \>18 years old; 2. diagnosed as having diabetes who were willing to perform the study and complete the data collection; 3. in stable condition prior to the study.
Exclusion criteria
1. pregnancy or attempting to conceive; 2. known allergy to medical grade adhesive or isopropyl alcohol used to prepare the skin; 3. skin lesions, scarring, redness, infection, or edema at the sensor application sites; 4. patients whose conditions were extremely severe and not stable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 3 months | Difference in HbA1c between intervention and control group at 3 month adjusting for baseline HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean blood glucose (MBG) | 1,2,3 months | Difference in HbA1c between intervention and control group at 1, 2, and 3 month. |
| coefficient of variation (CV) | 1,2,3 months | Difference in CV between intervention and control group at 1, 2, and 3 month. |
| area under the curve (AUC)<3.9mmol/L and >10mmol/L | 1,2,3 months | Difference in AUC\<3.9mmol/L and \>10mmol/L between intervention and control group at 1, 2, and 3 month. |
| Time in Range (TIR) | 1,2,3 months | Difference in time in range 3.9-10 mmol/L between intervention and control group at 1, 2, and 3 month. |
| FGM accuracy | during FGM | Accuracy of FGM values versus reference blood glucose values (Consensus Error Grid (CEG) analysis and calculation of the Mean Absolute Relative Difference (MARD) |
Countries
China
Contacts
Primary ContactMa Jianhua, MD
Outcome results
None listed