Effect of FGM on Glucose Control in Diabetic Patients

Nanjing Medical University

Status: Unknown

Conditions: Diabetes Mellitus

Treatments: Device: Freestyle Libre Flash Glucose Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03785301

KY20170904-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

FGM group

Experimental group

Description:

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

Treatment:

Device: Freestyle Libre Flash Glucose Monitoring

SMBG group

No Intervention group

Description:

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.