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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intervention by medical staff based on a cloud system
Sponsored by
Young Shin Song
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Remote intervention, Flash sensor-based glucose monitoring, Type 1 diabetes mellitus, Insulin-dependent diabetes mellitus

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHA Bundang Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No intervention by medical staff

Intervention by medical staff based on a cloud system

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in glycemic control measured by HbA1c
Difference between baseline HbA1c and follow-up HbA1c

Secondary Outcome Measures

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
Changes in the duration of hyperglycemic episodes
Difference in the duration of hyperglycemic glucose values (>180, 250 mg/dL) (baseline vs. follow-up)
Changes in the duration of hypoglycemic episodes
Difference in the duration of hypoglycemic glucose values (<70, 54 mg/dL) (baseline vs. follow-up)
Changes in hypoglycemic episodes
Difference between the frequency of hypoglycemic glucose values (<70, 54 mg/dL) (baseline vs. follow-up)
Changes in the mean glucose values
Difference in the mean glucose values (baseline vs. follow-up)
Changes in the frequency of use of trend arrows
Difference in the frequency of use of trend arrows (baseline vs. follow-up)
Changes in the mean number of scans
Difference in the mean number of scans per day (baseline vs. follow-up)
Changes in the insulin dose
Difference in the insulin dose (baseline vs. follow-up)
Changes in the lipid parameter
Difference in the levels of total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol (baseline vs. follow-up)
Changes in blood pressure
Difference in systolic blood pressure and diastolic blood pressure (baseline vs. follow-up)
Changes in body weight
Difference in body weight (baseline vs. follow-up)
Lifestyle changes in diet
Difference in the average number of meals and snacks per day (baseline vs. follow-up)
Lifestyle changes in the number of exercises
Difference in the average number of exercises per week (baseline vs. follow-up)
Lifestyle changes in the duration of exercises
Difference in the average duration of exercises per week (baseline vs. follow-up)
Changes in the patient absolute satisfaction with treatment assessed by questionnaires
Difference in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) scores (baseline vs. follow-up)
Changes in the patient relative satisfaction with treatment assessed by questionnaires
Difference in Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) scores (baseline vs. follow-up)
Changes in depression assessed by questionnaires
Difference in Patient Health Questionnaire-9 (PHQ-9) scores (baseline vs. follow-up)
Changes in anxiety assessed by questionnaires
Difference in General Anxiety Disorder-7 (GAD-7) scores (baseline vs. follow-up)

Full Information

First Posted
May 24, 2021
Last Updated
October 22, 2022
Sponsor
Young Shin Song
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1. Study Identification

Unique Protocol Identification Number
NCT04936633
Brief Title
Efficacy of FSGM Cloud-based Remote Intervention for Insulin-dEpendent Diabetic Patients (FRIEND)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Young Shin Song

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Remote intervention, Flash sensor-based glucose monitoring, Type 1 diabetes mellitus, Insulin-dependent diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No intervention by medical staff
Arm Type
No Intervention
Arm Description
The patients who start FSGM and receive general education on FSGM only.
Arm Title
Intervention by medical staff based on a cloud system
Arm Type
Experimental
Arm Description
The patients who start FSGM and receive general education on FSGM and remote intervention based on a cloud system.
Intervention Type
Other
Intervention Name(s)
Intervention by medical staff based on a cloud system
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in glycemic control measured by HbA1c
Description
Difference between baseline HbA1c and follow-up HbA1c
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Changes in the time in range
Description
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
Title
Changes in the duration of hyperglycemic episodes
Description
Difference in the duration of hyperglycemic glucose values (>180, 250 mg/dL) (baseline vs. follow-up)
Time Frame
3 months
Title
Changes in the duration of hypoglycemic episodes
Description
Difference in the duration of hypoglycemic glucose values (<70, 54 mg/dL) (baseline vs. follow-up)
Time Frame
3 months
Title
Changes in hypoglycemic episodes
Description
Difference between the frequency of hypoglycemic glucose values (<70, 54 mg/dL) (baseline vs. follow-up)
Time Frame
3 months
Title
Changes in the mean glucose values
Description
Difference in the mean glucose values (baseline vs. follow-up)
Time Frame
3 months
Title
Changes in the frequency of use of trend arrows
Description
Difference in the frequency of use of trend arrows (baseline vs. follow-up)
Time Frame
3 months
Title
Changes in the mean number of scans
Description
Difference in the mean number of scans per day (baseline vs. follow-up)
Time Frame
3 months
Title
Changes in the insulin dose
Description
Difference in the insulin dose (baseline vs. follow-up)
Time Frame
3 months
Title
Changes in the lipid parameter
Description
Difference in the levels of total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol (baseline vs. follow-up)
Time Frame
3 months
Title
Changes in blood pressure
Description
Difference in systolic blood pressure and diastolic blood pressure (baseline vs. follow-up)
Time Frame
3 months
Title
Changes in body weight
Description
Difference in body weight (baseline vs. follow-up)
Time Frame
3 months
Title
Lifestyle changes in diet
Description
Difference in the average number of meals and snacks per day (baseline vs. follow-up)
Time Frame
3 months
Title
Lifestyle changes in the number of exercises
Description
Difference in the average number of exercises per week (baseline vs. follow-up)
Time Frame
3 months
Title
Lifestyle changes in the duration of exercises
Description
Difference in the average duration of exercises per week (baseline vs. follow-up)
Time Frame
3 months
Title
Changes in the patient absolute satisfaction with treatment assessed by questionnaires
Description
Difference in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) scores (baseline vs. follow-up)
Time Frame
3 months
Title
Changes in the patient relative satisfaction with treatment assessed by questionnaires
Description
Difference in Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) scores (baseline vs. follow-up)
Time Frame
3 months
Title
Changes in depression assessed by questionnaires
Description
Difference in Patient Health Questionnaire-9 (PHQ-9) scores (baseline vs. follow-up)
Time Frame
3 months
Title
Changes in anxiety assessed by questionnaires
Description
Difference in General Anxiety Disorder-7 (GAD-7) scores (baseline vs. follow-up)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHA Bundang Medical Center
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
32543683
Citation
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.
Results Reference
background
PubMed Identifier
32543682
Citation
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.
Results Reference
background
PubMed Identifier
30844467
Citation
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.
Results Reference
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Efficacy of FSGM Cloud-based Remote Intervention for Insulin-dEpendent Diabetic Patients (FRIEND)

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