Efficacy, Safety and Satisfaction of the New Pen Needle 33 Gauge x 4 mm.

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy, Safety and Satisfaction of the New Pen Needle 33G x 4 mm 33G x 4 mm: Cross-over Randomized Controlled Clinical Trial. Studio AGO 01

Conditions
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Type 1 Diabetes, Type 2 Diabetes

Intervention / Treatment
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* Device: 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with type 1 or type 2 diabetes both males and females age >=18 anni insulin treatment from at least 6 months signed informed consent Exclusion Criteria: pregnancy incapacity for filling in the questionnaires every illness or condition that, according to the investigator, could interfere with the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: needle 4 mm gauge 33<br>Needle for insulin pen, 4 mm long and with a diameter of 33 gauge (the smaller needle) | Device: Needle for insulin pen, 4 mm long and with a diameter of 33 gauge<br> <br> |
| Active Comparator: needle 4 mm gauge 32<br>Needle for insulin pen, 4 mm long and with a diameter of 32 gauge | Device: Needle for insulin pen, 4 mm long and with a diameter of 32 gauge<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hematic fructosamine levels |  | Change from baseline in fructosamine levels after 3 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, insulin therapy, needle