Trials / Completed
CompletedNCT04936633
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)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Young Shin Song · Academic / Other
- Sex
- All
- Age
- 19 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 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 |
Timeline
- Start date
- 2021-06-30
- Primary completion
- 2022-04-30
- Completion
- 2022-04-30
- First posted
- 2021-06-23
- Last updated
- 2022-10-25
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04936633. Inclusion in this directory is not an endorsement.