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The purpose of this study is to demonstrate the superiority of iBGstar as a component of the diabetes treatment vs. traditional blood glucose self-monitoring system for improving glycemic control after 6 months in young patients with type 1 diabetes. The study is intended also to demonstrate the superiority of iBGStar as a component of the diabetes treatment vs. usual blood glucose self-monitoring system for improving the compliance to self monitoring of blood glucose after 6 months.
The planned study duration will be 20 months (5 quarters) with screening/enrollment of 7 months, followed by 2-3 weeks of a qualification phase, a 6 month experimental phase, plus a 6 month follow-up in the post-trial observational phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iBGStar (Group A) | Experimental | Self-Monitoring Blood Glucose will be managed with iBGStar and iBGStar Diabetes Manager Application (App) uploaded on iPhone for all duration of the study (6 months of experimental phase plus 6-months of observational phase). In the first 3 months, the patients in Group A will send their glycemic test values and notes by mail to the physician through Diabetes Manager App every 2 weeks. Afterwards until the visit V2 (six months), the patients in Group A will send their glycemic test values and notes by mail monthly. 9 reports in total. |
|
| Traditional Glucometer (Group B) | Active Comparator | Self-Monitoring Blood Glucose will be managed with a traditional glucometer according to usual care for the first 6 months (experimental phase). In the 6 months post-trial follow-up (observational phase), Self-Monitoring Blood Glucose will be managed with iBGStar and iBGStar Diabetes Manager App. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iBGStar | Device |
| ||
| Traditional Glucometer |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c levels from baseline | baseline to six months | |
| Proportion of participants performing at least 30% of the recommended Self-Monitoring Blood Glucose tests after 6 months from randomization | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with HbA1c ≤7.5% | at 6 months and 12 months | |
| Average number of recommended Self-Monitoring Blood Glucose tests daily, weekly, and monthly | at 6 months and 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi -Aventis Administrative Office | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28138788 | Derived | Di Bartolo P, Nicolucci A, Cherubini V, Iafusco D, Scardapane M, Rossi MC. Young patients with type 1 diabetes poorly controlled and poorly compliant with self-monitoring of blood glucose: can technology help? Results of the i-NewTrend randomized clinical trial. Acta Diabetol. 2017 Apr;54(4):393-402. doi: 10.1007/s00592-017-0963-4. Epub 2017 Jan 30. |
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|
| Mean fasting plasma glucose (FPG) and postprandial glucose (PPG) |
| at 6 months and 12 months |
| Mean Glycemic Variability | at 6 months and 12 months |
| Average Insulin Dose | at 6 months and 12 months |
| Number of Daily Injections | at 6 months and 12 months |
| Number of Insulin Dose Adjustments | at 6 months and 12 months |
| Quality of life: Audit of Diabetes Dependent Quality of Life (ADDQOL) (young adults 18-24 years) | at 6 months and 12 months |
| Diabetes Quality of Life (DQOL-Y) (adolescents 14-17 years) | at 6 months and 12 months |
| Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS) | at 6 months and 12 months |
| Number overall contacts between centers and participants | up to 12 months |
| Type of overall contacts between centers and participants | up to 12 months |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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