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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No intervention by medical staff | No Intervention | The patients who start FSGM and receive general education on FSGM only. | |
| Intervention by medical staff based on a cloud system | Experimental | The patients who start FSGM and receive general education on FSGM and remote intervention based on a cloud system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in glycemic control measured by HbA1c | Difference between baseline HbA1c and follow-up HbA1c | 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32543683 | Background | 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. | |
| 32543682 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
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 |
| Background |
| 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. |
| 30844467 | Background | 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. |
| 36506077 | Derived | 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |