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The study ended early due to CGM reimbursement policy changes, after that most patients eligible for the study could have isCGM reimbursed.
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| Name | Class |
|---|---|
| Diabetes Poland | UNKNOWN |
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The aim of this trial is to investigate the impact of FreeStyle Libre use compared to SMBG on hypoglycemia episodes and fear of hypoglycemia in adults aged 18-35 with newly diagnosed type 1 diabetes.
This trial is conducted in university centers in Poland (Bialystok, Krakow, Poznan, Zabrze).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FreeStyle Libre | Experimental | FreeStyle Libre for 4 weeks. All subjects will wear a masked sensor (FreeStyle Libre Pro) for 14 days prior to randomisation. |
|
| SMBG | Active Comparator | Subjects randomised to the control group will monitor their blood glucose with standard blood glucose meters. A 14-day FreeStyle Libre Pro is included for these subjects from day 14 to day 28 to collect glycaemic data for comparison to the intervention group of the study. All subjects will wear a masked sensor (FreeStyle Libre Pro) for 14 days prior to randomisation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittently Scanned Continuous Glucose Monitoring | Device | FreeStyle Libre, 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia Fear Survey II | Change in HFS II score from baseline to day 28 | Baseline and day 28 |
| TBR <70 mg/dL | Difference in time <70 mg/dL between intervention and control group assessed in days 14 to 28 | Baseline and days 14 to 28 |
| Measure | Description | Time Frame |
|---|---|---|
| TIR | Difference in TIR 70-180 mg/dL between intervention and control group assessed in days 14 to 28 | Baseline and days 14 to 28 |
| TBR <54 mg/dL | Difference in TBR <54 mg/dL between intervention and control group assessed in days 14 to 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok | Bialystok | Poland | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39850477 | Derived | Hohendorff J, Grzelka-Wozniak A, Wrobel M, Kania M, Lapinska L, Rokicka D, Stoltny D, Kowalska I, Strojek K, Zozulinska-Ziolkiewicz D, Malecki MT. Impact of the initiation of isCGM soon after type 1 diabetes mellitus diagnosis in adults on glycemic indices and fear of hypoglycemia: a randomized controlled trial. Front Endocrinol (Lausanne). 2025 Jan 9;15:1503891. doi: 10.3389/fendo.2024.1503891. eCollection 2024. |
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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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| Standard Blood Glucose Monitoring | Device | Standard blood glucose monitoring with glucose meters |
|
| Baseline and days 14 to 28 |
| TAR >180 mg/dl | Difference in TAR >180 mg/dL between intervention and control group assessed in days 14 to 28 | Baseline and days 14 to 28 |
| TAR >250 mg/dl | Difference in TAR >250 mg/dL between intervention and control group assessed in days 14 to 28 | Baseline and days 14 to 28 |
| DKA | Difference in number of hospitalizations for diabetic ketoacidosis between intervention and control group | Baseline to day 28 |
| Severe hypoglycemia | Difference in number of severe hypoglycemia episodes between intervention and control group | Baseline to day 28 |
| DDS | Change in DDS score from baseline to day 28 | Baseline and day 28 |
| DTSQ | Change in DTSQ score from baseline to day 28 | Baseline and day 28 |
| HFS II - Worry subscale | Change in HFS II - worry subscale from baseline to day 28 | Baseline and day 28 |
| HFS II - Behaviour subscale | Change in HFS II - behaviour subscale from baseline to day 28 | Baseline and day 28 |
| Department of Metabolic Diseases, Jagiellonian University Medical College |
| Krakow |
| Poland |
| Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences | Poznan | Poland |
| Department of Internal Medicine, Diabetology, and Cardiometabolic Disorders, Medical University of Silesia in Katowice | Zabrze | Poland |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |