Efficacy, Safety and Satisfaction of the New Pen Needle 33 Gauge x 4 mm. (AGO01)

Consorzio Mario Negri Sud

Status: Completed

Conditions: Type 1 Diabetes; Type 2 Diabetes

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT01745549

AGO01

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

needle 4 mm gauge 33

Experimental group

Description:

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

Treatment:

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

needle 4 mm gauge 32

Active Comparator group

Description:

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

Treatment:

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