Efficacy of FSGM Cloud-based Remote Intervention for Insulin-dEpendent Diabetic Patients (FRIEND)
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Other: Intervention by medical staff based on a cloud system
- Registration Number
- NCT04936633
- Lead Sponsor
- Young Shin Song
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention by medical staff based on a cloud system Intervention by medical staff based on a cloud system The patients who start FSGM and receive general education on FSGM and remote intervention based on a cloud system.
- Primary Outcome Measures
Name Time Method Changes in glycemic control measured by HbA1c 3 months Difference between baseline HbA1c and follow-up HbA1c
- Secondary Outcome Measures
Name Time Method Changes in the mean glucose values 3 months Difference in the mean glucose values (baseline vs. follow-up)
Changes in hypoglycemic episodes 3 months Difference between the frequency of hypoglycemic glucose values (\<70, 54 mg/dL) (baseline vs. follow-up)
Changes in the patient relative satisfaction with treatment assessed by questionnaires 3 months Difference in Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) scores (baseline vs. follow-up)
Changes in depression assessed by questionnaires 3 months Difference in Patient Health Questionnaire-9 (PHQ-9) scores (baseline vs. follow-up)
Changes in the duration of hypoglycemic episodes 3 months Difference in the duration of hypoglycemic glucose values (\<70, 54 mg/dL) (baseline vs. follow-up)
Changes in the duration of hyperglycemic episodes 3 months Difference in the duration of hyperglycemic glucose values (\>180, 250 mg/dL) (baseline vs. follow-up)
Changes in blood pressure 3 months Difference in systolic blood pressure and diastolic blood pressure (baseline vs. follow-up)
Changes in body weight 3 months Difference in body weight (baseline vs. follow-up)
Lifestyle changes in the duration of exercises 3 months Difference in the average duration of exercises per week (baseline vs. follow-up)
Changes in the time in range 3 months Difference in the duration of glucose values between 70 mg/dL and 180 mg/dL between baseline and the 3-month follow-up
Changes in the mean number of scans 3 months Difference in the mean number of scans per day (baseline vs. follow-up)
Changes in the frequency of use of trend arrows 3 months Difference in the frequency of use of trend arrows (baseline vs. follow-up)
Changes in the insulin dose 3 months Difference in the insulin dose (baseline vs. follow-up)
Changes in the lipid parameter 3 months Difference in the levels of total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol (baseline vs. follow-up)
Lifestyle changes in diet 3 months Difference in the average number of meals and snacks per day (baseline vs. follow-up)
Lifestyle changes in the number of exercises 3 months Difference in the average number of exercises per week (baseline vs. follow-up)
Changes in the patient absolute satisfaction with treatment assessed by questionnaires 3 months Difference in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) scores (baseline vs. follow-up)
Changes in anxiety assessed by questionnaires 3 months Difference in General Anxiety Disorder-7 (GAD-7) scores (baseline vs. follow-up)
Trial Locations
- Locations (1)
CHA Bundang Medical Center
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of