Effect of FGM on Glucose Control in Diabetic Patients

Diabetes Mellitus Clinical Trial

Official title:

Effect of FGM on Glucose Control in Diabetic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03785301
• Other study ID #: KY20170904-04
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2018
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Ma Jianhua, MD
• Phone: 8625-52887092
• Email: majianhua196503[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Nanjing First Hostital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Difference in HbA1c between intervention and control group at 3 month adjusting for baseline HbA1c	3 months
Secondary	mean blood glucose (MBG)	Difference in HbA1c between intervention and control group at 1, 2, and 3 month.	1,2,3 months
Secondary	coefficient of variation (CV)	Difference in CV between intervention and control group at 1, 2, and 3 month.	1,2,3 months
Secondary	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
Secondary	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
Secondary	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