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

Young Shin Song36 enrolled

Overview

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).

* 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

Intervention by medical staff based on a cloud systemOTHER

Remote intervention by medical staff (between Visit 1 and Visit 2; Week 2, 4, 6, 8, 10) : analyzing continuous glucose monitoring data for last two weeks in the cloud system \- Intervention contents 1. Diet, exercise pattern 2. Causes of hypoglycemia 3. Causes of hyperglycemia 4. Causes of glycemic variability 5. Counseling for improvement plans for the cause 6. Counseling to strengthen lifestyle modification 7. Counseling for insulin administration 8. Counseling for Insulin dose adjustment (adjusted dose) 9. Counseling for how to use a FSGM

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Changes in glycemic control measured by HbA1c

Difference between baseline HbA1c and follow-up HbA1c

Time frame: 3 months

Secondary Outcomes

Changes in the time in range

Difference in the duration of glucose values between 70 mg/dL and 180 mg/dL between baseline and the 3-month follow-up

Time frame: 3 months

Changes in the duration of hyperglycemic episodes

Difference in the duration of hyperglycemic glucose values (\>180, 250 mg/dL) (baseline vs. follow-up)

Time frame: 3 months

Changes in the duration of hypoglycemic episodes

Difference in the duration of hypoglycemic glucose values (\<70, 54 mg/dL) (baseline vs. follow-up)

Time frame: 3 months

Changes in hypoglycemic episodes

Difference between the frequency of hypoglycemic glucose values (\<70, 54 mg/dL) (baseline vs. follow-up)

Time frame: 3 months

Changes in the mean glucose values

Difference in the mean glucose values (baseline vs. follow-up)

Time frame: 3 months

Changes in the frequency of use of trend arrows

Difference in the frequency of use of trend arrows (baseline vs. follow-up)

Time frame: 3 months

Changes in the mean number of scans

Difference in the mean number of scans per day (baseline vs. follow-up)

Data from ClinicalTrials.gov

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