Effect of FGM on Glucose Control in Diabetic Patients

Not Applicable

• Conditions: Diabetes Mellitus
• Interventions: Device: Freestyle Libre Flash Glucose Monitoring

• Registration Number: NCT03785301
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Status Verified: 2018-08
• Study Start: 2018-12-20
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-24
• Last Update Submitted: 2019-06-09
• Last Update Posted: 2019-06-11
• Primary Completion: 2019-10-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
HbA1c	3 months	Difference in HbA1c between intervention and control group at 3 month adjusting for baseline HbA1c

Secondary Outcome Measures

Name	Time	Method
coefficient of variation (CV)	1,2,3 months	Difference in CV between intervention and control group at 1, 2, and 3 month.
mean blood glucose (MBG)	1,2,3 months	Difference in HbA1c 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)

Trial Locations

Locations (1)

Nanjing First Hostital; 🇨🇳 Nanjing, Jiangsu, China