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

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Type 2 Diabetes
• Interventions: 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

• Registration Number: NCT01745549
• Lead Sponsor: Consorzio Mario Negri Sud

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-06
• Study First Posted: 2012-12-10
• Primary Completion: 2013-09
• Study Completion: 2013-11
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-17
• Last Update Posted: 2014-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
needle 4 mm gauge 33	Needle for insulin pen, 4 mm long and with a diameter of 33 gauge	Needle for insulin pen, 4 mm long and with a diameter of 33 gauge (the smaller needle)
needle 4 mm gauge 32	Needle for insulin pen, 4 mm long and with a diameter of 32 gauge	Needle for insulin pen, 4 mm long and with a diameter of 32 gauge

Primary Outcome Measures

Name	Time	Method
hematic fructosamine levels	Change from baseline in fructosamine levels after 3 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
mean amplitude of glucose excursions (MAGE)	Change from baseline in MAGE after 3 weeks of treatment
pain	questionnaire at the end of the treatments (at 6 weeks)	visual analogic scale (VAS) 1-10
leakage at the site injection	number of episodes of leakage during the treatment (3 weeks)	visual scale
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	questionnaire at the end of the treatments (at 6 weeks)	VAS scale

Trial Locations

Locations (4)

UO Malattie Metaboliche e Diabetologia - Ospedale di Treviglio-Caravaggio; 🇮🇹 Treviglio, BG, Italy

UO Diabetologia per Trattamento e Educazione dei Diabetici - Spedali Civili di Brescia; 🇮🇹 Brescia, BS, Italy

U.O.S. Diabetologia e Malattie Metaboliche - PO Cantù - Mariano Comense; 🇮🇹 Mariano Comense, CO, Italy

Struttura Complessa Dietologia-Diabetologia Malattie Metaboliche - Ospedale Pertini; 🇮🇹 Roma, RM, Italy