The Evaluation of Consistency by Finger Stick Blood Glucose or Venous Blood Glucose of Flash Glucose Monitoring in Different Infiltration Time

This is a prospective randomized controlled study to evaluate consistency by finger stick blood glucose or venous blood glucose in different infiltration time (including the time between activation of the sensor and storage of the first blood glucose value) of Flash glucose monitoring(FGM). In this study, the relationship between the dynamic blood glucose and finger stick blood glucose or venous blood glucose in type 2 diabetes mellitus patients(T2DM), was explored. And the investigators also analyzed the deviation and accuracy of FGM in practical application,so as to provide a good reference for clinical application.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes; Flash Glucose Monitoring; Conscience
• Intervention / Treatment: Device: FGM infiltration 1 hour group; Device: FGM infiltration 6-hour group; Device: FGM infiltration 12-hour group

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • endocrinology department of the first affiliated hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with type 2 diabetes fit the 1999 who diagnostic criteria for diabetes
• Aged 18 or above
• Without serious complications, such as diabetic ketoacidosis, severe infection,severe cardiac insufficiency, severe liver and kidney diseases
• Voluntary and signed informed consent to participate
• Be able to read and understand Chinese, perform all research visits and tasks, and follow research instructions

Exclusion Criteria:

• Patients with known allergy to medical grade adhesive or isopropanol used for skin disinfection, edema, skin damage, scar, redness, infection, etc. during pregnancy or preparation of pregnancy or at the sensor application site (dorsal side of upper arm).
• The examinee took drugs such as ascorbic acid (vitamin C) and salicylic acid (an ingredient in aspirin and many painkillers) that affected the accuracy of the sensor.
• MRI is required during the study.
• The examinee had poor compliance and could not continue to complete the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1-hour group; The time between the activation of the sensor and the storage of the first blood glucose value is 1 hour.	Device: FGM infiltration 1 hour group; The sensor is activated immediately after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour).
Experimental: 6-hour group; The time between the activation of the sensor and the storage of the first blood glucose value is 6 hours.	Device: FGM infiltration 6-hour group; Reactivate the sensor 5 hours after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour).
Experimental: 12-hour group; The time between the activation of the sensor and the storage of the first blood glucose value is 12 hours.	Device: FGM infiltration 12-hour group; Reactivate the sensor 11 hours after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference value	The difference between finger stick blood glucose or venous blood glucose and FGM value.	Up to 21 days

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020477

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No