Effect of FGM on Glucose Control in Diabetic Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of FGM on Glucose Control in Diabetic Patients

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Freestyle Libre Flash Glucose Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years old; diagnosed as having diabetes who were willing to perform the study and complete the data collection; in stable condition prior to the study. Exclusion Criteria: pregnancy or attempting to conceive; known allergy to medical grade adhesive or isopropyl alcohol used to prepare the skin; skin lesions, scarring, redness, infection, or edema at the sensor application sites; patients whose conditions were extremely severe and not stable.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FGM group<br>Diabetic patients will use FreeStyle Libre Flash Glucose Monitoring (FGM) system(unmasked) to monitor glucose level once a month for 3 months. | Device: Freestyle Libre Flash Glucose Monitoring<br>* 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.<br>|
| No Intervention: SMBG group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Difference in HbA1c between intervention and control group at 3 month adjusting for baseline HbA1c | 3 months | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |