Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.

Study Overview
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Brief Summary
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The purpose of this study is to determine the non-inferiority of a new Pic Insupen 34Gx3,5mm needle vs. a 32Gx4mm needle in terms of metabolic control, safety and acceptability in patients with diabetes treated with insulin.

Official Title
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Efficacy, Safety and Acceptability of the New Pen Needle 33G x 4 mm: a Cross-over Randomised Non Inferiority Trial

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Insupen G34x3,5mm
* Device: Insupen G32x4mm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with type 1 or type 2 diabetes Age >= 18 years Multiple daily injections of insulin for at least 6 months Signed informed consent Exclusion Criteria: Pregnancy or or breast feeding Inability to fill in the questionnaire Combined therapy for diabetes (oral drugs associated with insulin injections) Any medical condition that could interfere with the study according to the investigator's opinion

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: Insupen G34x3,5mm<br>Needle for insulin pen 3,5 mm long and with a diameter of 34 gauge | Device: Insupen G34x3,5mm<br> <br> |
| Active Comparator: Insupen G32x4mm<br>Needle for insulin pen 4 mm long and with a diameter of 32 gauge | Device: Insupen G32x4mm<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic variability expressed as the standard deviation of fasting blood and postprandial glucose levels | Change from baseline in glycemic variability after 3 weeks of treatment | 3 weeks | 
| Daily insulin dose | Change from baseline in daily insulin dose after 3 weeks of treatment | 3 weeks | 
| Body weight | Change from baseline in body weight after 3 weeks of treatment | 3 weeks | 
| Pain | Pain measured by visual analogue scale after 3 weeks of treatment | 3 weeks | 
| Patient satisfaction measured by a questionnaire | Patient satisfaction measured by a questionnaire after 3 weeks of treatment | 3 weeks | 
| Number of patients with hypoglycaemia | Number of patients with hypoglycaemia during 3 weeks | 3 weeks | 
| Number of hypoglycaemia episodes | Total number of phypoglycaemia episodes during 3 weeks | 3 weeks | 
| Number of episodes of insulin leakage at injection site | Number of episodes of insulin leakage at injection site during 3 weeks of treatment | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin therapy, Needle