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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Flash Glucose Monitoring Conscience

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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1-hour group

The time between the activation of the sensor and the storage of the first blood glucose value is 1 hour.

Group Type ACTIVE_COMPARATOR

FGM infiltration 1 hour group

Intervention Type DEVICE

The sensor is activated immediately after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour).

6-hour group

The time between the activation of the sensor and the storage of the first blood glucose value is 6 hours.

Group Type EXPERIMENTAL

FGM infiltration 6-hour group

Intervention Type DEVICE

Reactivate the sensor 5 hours after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour).

12-hour group

The time between the activation of the sensor and the storage of the first blood glucose value is 12 hours.

Group Type EXPERIMENTAL

FGM infiltration 12-hour group

Intervention Type DEVICE

Reactivate the sensor 11 hours after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour).

Interventions

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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).

Intervention Type 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).

Intervention Type 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).

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No