Efficacy of Remote Intervention by Medical Staff Based on a Cloud System of Continuous Glucose Monitoring Data in Patients With Insulin-dependent Diabetes Using a Flash Sensor-based Glucose Monitoring (FSGM)

Young Shin Song1 site in 1 country36 target enrollmentJune 30, 2021

ConditionsType 1 Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 1 Diabetes Mellitus
Sponsor: Young Shin Song
Enrollment: 36
Locations: 1
Primary Endpoint: Changes in glycemic control measured by HbA1c
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To investigate the efficacy of remote intervention by medical staff based on a cloud system of continuous glucose monitoring data in patients with insulin-dependent diabetes using flash sensor-based glucose monitoring (FSGM).

Detailed Description

* Previous studies have been reported on the efficacy of CGM or FSGM and education on glucose control in insulin-dependent diabetes patients. * This study aims to investigate whether it is more effective to receive remote intervention by medical staff based on a cloud system, than only to use FSGM and receive general education on FSGM. * Trial design : parallel group, allocation ratio 1:1, a superiority study design

Registry

clinicaltrials.gov

Start Date

June 30, 2021

End Date

April 30, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Young Shin Song

Responsible Party

Sponsor Investigator

Principal Investigator

Young Shin Song

A ssistant Professor

CHA University

Eligibility Criteria

Inclusion Criteria

•Men or women aged 19 to 75 years old
•Patients with type 1 diabetes
•Patients on multiple daily insulin-injection or continuous subcutaneous insulin infusion therapy for more than 1 year
•Patients with HbA1c ≥ 7.0% at screening
•Patients willing to use a FSGM system
•Patients with informed consent

Exclusion Criteria

•Gestational diabetes patients
•Patients within 1 year of diabetic diagnosis
•Patients taking drugs for severe cognitive impairment or psychiatric problems
•Patients who received oral or parenteral corticosteroid therapy for more than 7 consecutive days within 1 month before screening test
•Patients with severe infection, before and after surgery, and severe trauma
•Patients on dialysis at the end of renal failure
•Patients who have a history of substance abuse or alcoholism within 12 weeks through patient history taking, diagnosis records, and past treatment records
•Pregnant or lactating women
•Participating in other clinical trials under R\&D other than this clinical trial, or if other clinical trial drugs are administered within 4 weeks before the trial
•Patients who are using a CGMS/FSGM or who have been using it within 12 weeks

Outcomes

Primary Outcomes

Changes in glycemic control measured by HbA1c

Time Frame: 3 months

Difference between baseline HbA1c and follow-up HbA1c

Secondary Outcomes

Changes in the mean glucose values(3 months)
Changes in hypoglycemic episodes(3 months)
Changes in the patient relative satisfaction with treatment assessed by questionnaires(3 months)
Changes in depression assessed by questionnaires(3 months)
Changes in the duration of hypoglycemic episodes(3 months)
Changes in the duration of hyperglycemic episodes(3 months)
Changes in blood pressure(3 months)
Changes in body weight(3 months)
Lifestyle changes in the duration of exercises(3 months)
Changes in the time in range(3 months)
Changes in the mean number of scans(3 months)
Changes in the frequency of use of trend arrows(3 months)
Changes in the insulin dose(3 months)
Changes in the lipid parameter(3 months)
Lifestyle changes in diet(3 months)
Lifestyle changes in the number of exercises(3 months)
Changes in the patient absolute satisfaction with treatment assessed by questionnaires(3 months)
Changes in anxiety assessed by questionnaires(3 months)