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

Not Applicable

• Conditions: Diabetes Mellitus
• Interventions: Device: Insupen G32x4mm; Device: Insupen G34x3,5mm

• Registration Number: NCT02690467
• Lead Sponsor: Center for Outcomes Research and Clinical Epidemiology, Italy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-24
• Study Start: 2016-09-06
• Status Verified: 2017-01
• Primary Completion: 2017-03-23
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-25
• Study Completion: 2017-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insupen G32x4mm	Insupen G32x4mm	Needle for insulin pen 4 mm long and with a diameter of 32 gauge
Insupen G34x3,5mm	Insupen G34x3,5mm	Needle for insulin pen 3,5 mm long and with a diameter of 34 gauge

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Struttura Semplice Dipartimentale di Diabetologia e Malattie Metaboliche - Az. Osp. S. Anna - PO Cantù; 🇮🇹 Mariano Comense, CO, Italy

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

U.O. Malattie Metaboliche e Diabetologia - Ospedale Treviglio; 🇮🇹 Treviglio, BG, Italy

Struttura Semplice Dipartimentale Diabetologia, Endocrinologia e Nutrizione Clinica - Az. Osp. Desio e Vimercate; 🇮🇹 Desio, MI, Italy