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

NCT04099745 | Unknown

• 1 other identifier: KY20190823-02
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Type 2 Diabetes

Keywords

FGM; CGM

Outcome Measures

Primary Outcomes (1)

• Accuracy of different blood glucose monitoring systems (CGM and FGM) with intravenous blood glucose level as the gold standard

  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.

  2 weeks

Secondary Outcomes (2)

• three-day blood glucose fluctuation of CGM

  3 DAYS

• forty-day blood glucose fluctuation of FGM

  14 days

Study Arms (2)

CGM（continuous glucose monitoring）

EXPERIMENTAL

Each diabetic patient received three CGM tests within 14 days of FGM monitoring, on days 1-3, 6-9 and 12-14, respectively.

Device: CGM

FGM（Flash glucose monitoring）

EXPERIMENTAL

Each diabetic patient received one FGM test for 14 days.

Device: FGM

Interventions

CGM DEVICE

Continuous Glucose Monitoring System

CGM（continuous glucose monitoring）

FGM DEVICE

Flash glucose monitoring System

FGM（Flash glucose monitoring）

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 23, 2019
• Study Start: October 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: February 1, 2020
• Last Updated: September 23, 2019

Record last verified: 2019-09