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

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)

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).

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Other: Intervention by medical staff based on a cloud system

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

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 13496
      • CHA Bundang Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention by medical staff; The patients who start FSGM and receive general education on FSGM only.
Experimental: 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.	Other: Intervention by medical staff based on a cloud system; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Young Shin Song

Publications and helpful links

General Publications

• Laffel LM, Kanapka LG, Beck RW, Bergamo K, Clements MA, Criego A, DeSalvo DJ, Goland R, Hood K, Liljenquist D, Messer LH, Monzavi R, Mouse TJ, Prahalad P, Sherr J, Simmons JH, Wadwa RP, Weinstock RS, Willi SM, Miller KM; CGM Intervention in Teens and Young Adults with T1D (CITY) Study Group; CDE10. Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2388-2396. doi: 10.1001/jama.2020.6940.
• Pratley RE, Kanapka LG, Rickels MR, Ahmann A, Aleppo G, Beck R, Bhargava A, Bode BW, Carlson A, Chaytor NS, Fox DS, Goland R, Hirsch IB, Kruger D, Kudva YC, Levy C, McGill JB, Peters A, Philipson L, Philis-Tsimikas A, Pop-Busui R, Shah VN, Thompson M, Vendrame F, Verdejo A, Weinstock RS, Young L, Miller KM; Wireless Innovation for Seniors With Diabetes Mellitus (WISDM) Study Group. Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2397-2406. doi: 10.1001/jama.2020.6928.
• Hermanns N, Ehrmann D, Schipfer M, Kroger J, Haak T, Kulzer B. The impact of a structured education and treatment programme (FLASH) for people with diabetes using a flash sensor-based glucose monitoring system: Results of a randomized controlled trial. Diabetes Res Clin Pract. 2019 Apr;150:111-121. doi: 10.1016/j.diabres.2019.03.003. Epub 2019 Mar 4.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 22, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Type 1 diabetes mellitus; Remote intervention; Flash sensor-based glucose monitoring; Insulin-dependent diabetes mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2021-03-032-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No