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

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Other: Intervention by medical staff based on a cloud system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention by medical staff<br>The patients who start FSGM and receive general education on FSGM only. | |
| Experimental: Intervention by medical staff based on a cloud system<br>The patients who start FSGM and receive general education on FSGM and remote intervention based on a cloud system. | Other: Intervention by medical staff based on a cloud system<br>* 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 Diet, exercise pattern Causes of hypoglycemia Causes of hyperglycemia Causes of glycemic variability Counseling for improvement plans for the cause Counseling to strengthen lifestyle modification Counseling for insulin administration Counseling for Insulin dose adjustment (adjusted dose) Counseling for how to use a FSGM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in glycemic control measured by HbA1c | Difference between baseline HbA1c and follow-up HbA1c | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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) | 3 months | 
| Changes in hypoglycemic episodes | Difference between the frequency of hypoglycemic glucose values (<70, 54 mg/dL) (baseline vs. follow-up) | 3 months | 
| Changes in the mean glucose values | Difference in the mean glucose values (baseline vs. follow-up) | 3 months | 
| Changes in the frequency of use of trend arrows | Difference in the frequency of use of trend arrows (baseline vs. follow-up) | 3 months | 
| Changes in the mean number of scans | Difference in the mean number of scans per day (baseline vs. follow-up) | 3 months | 
| Changes in the insulin dose | Difference in the insulin dose (baseline vs. follow-up) | 3 months | 
| Changes in the lipid parameter | Difference in the levels of total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol (baseline vs. follow-up) | 3 months | 
| Changes in blood pressure | Difference in systolic blood pressure and diastolic blood pressure (baseline vs. follow-up) | 3 months | 
| Changes in body weight | Difference in body weight (baseline vs. follow-up) | 3 months | 
| Lifestyle changes in diet | Difference in the average number of meals and snacks per day (baseline vs. follow-up) | 3 months | 
| Lifestyle changes in the number of exercises | Difference in the average number of exercises per week (baseline vs. follow-up) | 3 months | 
| Lifestyle changes in the duration of exercises | Difference in the average duration of exercises per week (baseline vs. follow-up) | 3 months | 
| Changes in the patient absolute satisfaction with treatment assessed by questionnaires | Difference in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) scores (baseline vs. follow-up) | 3 months | 
| Changes in the patient relative satisfaction with treatment assessed by questionnaires | Difference in Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) scores (baseline vs. follow-up) | 3 months | 
| Changes in depression assessed by questionnaires | Difference in Patient Health Questionnaire-9 (PHQ-9) scores (baseline vs. follow-up) | 3 months | 
| Changes in anxiety assessed by questionnaires | Difference in General Anxiety Disorder-7 (GAD-7) scores (baseline vs. follow-up) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remote intervention, Flash sensor-based glucose monitoring, Type 1 diabetes mellitus, Insulin-dependent diabetes mellitus