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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-11-30

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.

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Detailed Description

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Conditions

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Type 1 Diabetes Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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needle 4 mm gauge 33

Needle for insulin pen, 4 mm long and with a diameter of 33 gauge (the smaller needle)

Group Type EXPERIMENTAL

Needle for insulin pen, 4 mm long and with a diameter of 33 gauge

Intervention Type DEVICE

needle 4 mm gauge 32

Needle for insulin pen, 4 mm long and with a diameter of 32 gauge

Group Type ACTIVE_COMPARATOR

Needle for insulin pen, 4 mm long and with a diameter of 32 gauge

Intervention Type DEVICE

Interventions

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Needle for insulin pen, 4 mm long and with a diameter of 33 gauge

Intervention Type DEVICE

Needle for insulin pen, 4 mm long and with a diameter of 32 gauge

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No