Efficacy of FSGM Cloud-based Remote Intervention for Insulin-dEpendent Diabetic Patients (FRIEND)

Young Shin Song

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Other: Intervention by medical staff based on a cloud system

Study type: Interventional

Funder types: Other

Identifiers

NCT04936633

2021-03-032-001

Details and patient eligibility

About

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).

Full 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

Enrollment: 36 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

No intervention by medical staff

No Intervention group

Description:

The patients who start FSGM and receive general education on FSGM only.

Intervention by medical staff based on a cloud system

Experimental group

Description:

The patients who start FSGM and receive general education on FSGM and remote intervention based on a cloud system.

Treatment:

Other: Intervention by medical staff based on a cloud system