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

September 19, 2019 updated by: Nanjing First Hospital, Nanjing Medical University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CGM（continuous glucose monitoring）
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
Continuous Glucose Monitoring System
Experimental: FGM（Flash glucose monitoring）
Each diabetic patient received one FGM test for 14 days.
Device: FGM
Flash glucose monitoring System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of different blood glucose monitoring systems (CGM and FGM) with intravenous blood glucose level as the gold standard
Time Frame: 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.
2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

September 16, 2019

First Submitted That Met QC Criteria

September 19, 2019

First Posted (Actual)

September 23, 2019

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KY20190823-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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