Clinical trial NCT03785301: Effect of FGM on Glucose Control in Diabetic Patients
Official title: Effect of FGM on Glucose Control in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
timeFrame: 3 months
Secondary outcomes:
measure: mean blood glucose (MBG)
timeFrame: 1,2,3 months
measure: coefficient of variation (CV)
timeFrame: 1,2,3 months
measure: area under the curve (AUC)<3.9mmol/L and >10mmol/L
timeFrame: 1,2,3 months
measure: Time in Range (TIR)
timeFrame: 1,2,3 months
measure: FGM accuracy
timeFrame: during FGM
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hostital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Ma Jianhua, MD
role: STUDY_CHAIR
References:
citation: Chen M, Li H, Shen Y, Liu B, Yan R, Sun X, Ye L, Lee KO, Ma J, Su X. Flash Glucose Monitoring Improves Glucose Control in People with Type 2 Diabetes Mellitus Receiving Anti-diabetic Drug Medication. Exp Clin Endocrinol Diabetes. 2021 Dec;129(12):857-863. doi: 10.1055/a-0994-9850. Epub 2020 Aug 28.
citation: Hu Y, Shen Y, Yan R, Li F, Ding B, Wang H, Su X, Ma J. Relationship Between Estimated Glycosylated Hemoglobin Using Flash Glucose Monitoring and Actual Measured Glycosylated Hemoglobin in a Chinese Population. Diabetes Ther. 2020 Sep;11(9):2019-2027. doi: 10.1007/s13300-020-00879-x. Epub 2020 Jul 21.