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Type 1 Diabetes MellitusNCT04936633

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

A study testing Intervention by medical staff based on a cloud system in people with Type 1 Diabetes Mellitus, run by Young Shin Song at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Intervention by medical staff based on a cloud system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSouth Korea
Study dates
30 Jun 2021to 30 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • CHA Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 13496

Other trials in South Korea

About this study

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)

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).

Read the 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
Being tested
Intervention by medical staff based on a cloud system
Keywords
Remote intervention, Flash sensor-based glucose monitoring, Type 1 diabetes mellitus, Insulin-dependent diabetes mellitus
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention by medical staff based on a cloud systemOther

    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
    1. Diet, exercise pattern
    2. Causes of hypoglycemia
    3. Causes of hyperglycemia
    4. Causes of glycemic variability
    5. Counseling for improvement plans for the cause
    6. Counseling to strengthen lifestyle modification
    7. Counseling for insulin administration
    8. Counseling for Insulin dose adjustment (adjusted dose)
    9. Counseling for how to use a FSGM
Study groups in NCT04936633
Study groupRoleWhat they receive
No intervention by medical staffNo interventionThe patients who start FSGM and receive general education on FSGM only.
Intervention by medical staff based on a cloud systemExperimentalThe patients who start FSGM and receive general education on FSGM and remote intervention based on a cloud system.
Receives: Other: Intervention by medical staff based on a cloud system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in glycemic control measured by HbA1c

    Difference between baseline HbA1c and follow-up HbA1c

    Measured: 3 months

Secondary outcomes (18)

  1. 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

    Measured: 3 months

  2. Changes in the duration of hyperglycemic episodes

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

    Measured: 3 months

  3. Changes in the duration of hypoglycemic episodes

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

    Measured: 3 months

  4. Changes in hypoglycemic episodes

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

    Measured: 3 months

  5. Changes in the mean glucose values

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

    Measured: 3 months

  6. Changes in the frequency of use of trend arrows

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

    Measured: 3 months

  7. Changes in the mean number of scans

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

    Measured: 3 months

  8. Changes in the insulin dose

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

    Measured: 3 months

  9. Changes in the lipid parameter

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

    Measured: 3 months

  10. Changes in blood pressure

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

    Measured: 3 months

  11. Changes in body weight

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

    Measured: 3 months

  12. Lifestyle changes in diet

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

    Measured: 3 months

  13. Lifestyle changes in the number of exercises

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

    Measured: 3 months

  14. Lifestyle changes in the duration of exercises

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

    Measured: 3 months

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

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

    Measured: 3 months

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

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

    Measured: 3 months

  17. Changes in depression assessed by questionnaires

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

    Measured: 3 months

  18. Changes in anxiety assessed by questionnaires

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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2021
  2. Study start30 Jun 2021
  3. Primary completion30 Apr 2022
  4. Study completion30 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04936633
Sponsor's protocol ID
2021-03-032-001
Status last verified
Oct 2022
First submitted
24 May 2021
Last updated
25 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 32543683

  • 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.

    PubMed 32543682

  • 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.

    PubMed 30844467

  • Lee J, Lee MH, Park J, Kim KS, Kim SK, Cho YW, Han HW, Song YS. FGM-based remote intervention for adults with type 1 diabetes: The FRIEND randomized clinical trial. Front Endocrinol (Lausanne). 2022 Nov 25;13:1054697. doi: 10.3389/fendo.2022.1054697. eCollection 2022.

    PubMed 36506077

Questions about this trial

What is this clinical trial studying?

A study testing Intervention by medical staff based on a cloud system in people with Type 1 Diabetes Mellitus, run by Young Shin Song at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in glycemic control measured by HbA1c (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04936633, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.

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