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Completed

NCT Number: NCT04936633

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

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).

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention by medical staff based on a cloud system

Other

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 outcomes

  1. Changes in glycemic control measured by HbA1c

    Time frame: 3 months

    Difference between baseline HbA1c and follow-up HbA1c

Secondary outcomes

  1. Changes in the time in range

    Time frame: 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

  2. Changes in the duration of hyperglycemic episodes

    Time frame: 3 months

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

  3. Changes in the duration of hypoglycemic episodes

    Time frame: 3 months

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

  4. Changes in hypoglycemic episodes

    Time frame: 3 months

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

  5. Changes in the mean glucose values

    Time frame: 3 months

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

  6. Changes in the frequency of use of trend arrows

    Time frame: 3 months

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

  7. Changes in the mean number of scans

    Time frame: 3 months

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

  8. Changes in the insulin dose

    Time frame: 3 months

    Difference in the insulin dose (baseline vs. follow-up)

  9. Changes in the lipid parameter

    Time frame: 3 months

    Difference in the levels of total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol (baseline vs. follow-up)

  10. Changes in blood pressure

    Time frame: 3 months

    Difference in systolic blood pressure and diastolic blood pressure (baseline vs. follow-up)

  11. Changes in body weight

    Time frame: 3 months

    Difference in body weight (baseline vs. follow-up)

  12. Lifestyle changes in diet

    Time frame: 3 months

    Difference in the average number of meals and snacks per day (baseline vs. follow-up)

  13. Lifestyle changes in the number of exercises

    Time frame: 3 months

    Difference in the average number of exercises per week (baseline vs. follow-up)

  14. Lifestyle changes in the duration of exercises

    Time frame: 3 months

    Difference in the average duration of exercises per week (baseline vs. follow-up)

  15. Changes in the patient absolute satisfaction with treatment assessed by questionnaires

    Time frame: 3 months

    Difference in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) scores (baseline vs. follow-up)

  16. Changes in the patient relative satisfaction with treatment assessed by questionnaires

    Time frame: 3 months

    Difference in Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) scores (baseline vs. follow-up)

  17. Changes in depression assessed by questionnaires

    Time frame: 3 months

    Difference in Patient Health Questionnaire-9 (PHQ-9) scores (baseline vs. follow-up)

  18. Changes in anxiety assessed by questionnaires

    Time frame: 3 months

    Difference in General Anxiety Disorder-7 (GAD-7) scores (baseline vs. follow-up)

Sponsors and collaborators

Lead sponsor

Young Shin Song

Other

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2021
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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