Effect of FGM on Glucose Control in Diabetic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-20

Study Completion Date

2019-12-31

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.

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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FGM group

Diabetic patients will use FreeStyle Libre Flash Glucose Monitoring (FGM) system(unmasked) to monitor glucose level once a month for 3 months.

Group Type EXPERIMENTAL

Freestyle Libre Flash Glucose Monitoring

Intervention Type 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.

SMBG group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Freestyle Libre Flash Glucose Monitoring

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No