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| Name | Class |
|---|---|
| Artsana S.p.a. | INDUSTRY |
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During the last years, even more little needles are used for the injection of sub cutaneous insulin, for the diabetes therapy.
The aim of this study is to evaluate the non inferiority of a new needle, smaller than another needle, in terms of hematic levels od fructosamine, an indicator of glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| needle 4 mm gauge 33 | Experimental | Needle for insulin pen, 4 mm long and with a diameter of 33 gauge (the smaller needle) |
|
| needle 4 mm gauge 32 | Active Comparator | Needle for insulin pen, 4 mm long and with a diameter of 32 gauge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Needle for insulin pen, 4 mm long and with a diameter of 33 gauge | Device |
| ||
| Needle for insulin pen, 4 mm long and with a diameter of 32 gauge |
| Measure | Description | Time Frame |
|---|---|---|
| hematic fructosamine levels | Change from baseline in fructosamine levels after 3 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| mean amplitude of glucose excursions (MAGE) | Change from baseline in MAGE after 3 weeks of treatment | |
| pain | visual analogic scale (VAS) 1-10 | questionnaire at the end of the treatments (at 6 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Nicolucci, MD | Consorzio Mario Negri Sud | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UO Malattie Metaboliche e Diabetologia - Ospedale di Treviglio-Caravaggio | Treviglio | BG | 24047 | Italy | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25469829 | Derived | Valentini M, Scardapane M, Bondanini F, Bossi A, Colatrella A, Girelli A, Ciucci A, Leotta S, Minotti E, Pasotti F, Pesenti A, Rocca L, Sciangula L, Vavassori E, Nicolucci A. Efficacy, safety and acceptability of the new pen needle 33G x 4 mm. AGO 01 study. Curr Med Res Opin. 2015 Mar;31(3):487-92. doi: 10.1185/03007995.2014.993025. Epub 2014 Dec 10. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| 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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| ID | Term |
|---|---|
| D009339 | Needles |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Device |
|
| leakage at the site injection | visual scale | number of episodes of leakage during the treatment (3 weeks) |
| hypoglycemia | number of episodes of hypoglycemia during the treatment (3 weeks) |
| insulin dosage | Change from baseline in insulin dosage after 3 weeks of treatment |
| patient's weight | Change from baseline in weight after 3 weeks of treatment |
| patient's satisfaction | VAS scale | questionnaire at the end of the treatments (at 6 weeks) |
| UO Diabetologia per Trattamento e Educazione dei Diabetici - Spedali Civili di Brescia |
| Brescia |
| BS |
| 25123 |
| Italy |
| U.O.S. Diabetologia e Malattie Metaboliche - PO Cantù - Mariano Comense | Mariano Comense | CO | 22066 | Italy |
| Struttura Complessa Dietologia-Diabetologia Malattie Metaboliche - Ospedale Pertini | Roma | RM | 00157 | Italy |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |