Comparing the Accuracy of Different Blood Glucose Monitoring Systems (CGM and FGM)

Comparing the Accuracy of Different Blood Glucose Monitoring Systems (CGM and FGM) With Venous Blood Glucose

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04099745

Enrollment

Registered

2019-09-23

Start date

2019-10-01

Completion date

2020-02-01

Last updated

2019-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

FGM, CGM

Brief summary

To compare the accuracy of different blood glucose monitoring systems (CGM and FGM) in diabetic patients with insufficient islet function.

Detailed description

To compare the accuracy of different blood glucose monitoring systems (CGM and FGM) in diabetic patients with insufficient islet function with Venous Blood Glucose (including FGM early, middle and late, pre-and post-meal, high and low blood glucose).

Interventions

DEVICECGM

Continuous Glucose Monitoring System

DEVICEFGM

Flash glucose monitoring System

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* volunteer to participate and be able to sign informed consent prior to the trial. * patients with type 2 diabetes or type 1 diabetes, aged 18-80 years old. * No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc. * Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.

Exclusion criteria

* Patients with insulin allergy. * Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal. * Drug abuse and alcohol dependence in the past 5 years. * Systemic hormone therapy was used in the last three months. * Patients with poor compliance and irregular diet and exercise. * Patients with pregnancy, lactation or pregnancy intention. * Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of different blood glucose monitoring systems (CGM and FGM) with intravenous blood glucose level as the gold standard	2 weeks	To compare the accuracy of different blood glucose monitoring systems (CGM and FGM) with intravenous blood glucose level as the gold standard in diabetic patients with insufficient islet function.

Secondary

Measure	Time frame
three-day blood glucose fluctuation of CGM	3 DAYS
forty-day blood glucose fluctuation of FGM	14 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026