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

Center for Outcomes Research and Clinical Epidemiology, Italy80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus

Interventions

Insupen G34x3,5mmDEVICE

Insupen G32x4mmDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

U.O. Malattie Metaboliche e Diabetologia - Ospedale Treviglio

Treviglio, BG, Italy

RECRUITING

Struttura Semplice Dipartimentale di Diabetologia e Malattie Metaboliche - Az. Osp. S. Anna - PO Cantù

Mariano Comense, CO, Italy

RECRUITING

Struttura Semplice Dipartimentale Diabetologia, Endocrinologia e Nutrizione Clinica - Az. Osp. Desio e Vimercate

Desio, MI, Italy

Outcomes

Primary Outcomes

Fructosamine levels

Change from baseline in fructosamine levels after 3 weeks of treatment

Time frame: 3 weeks

Secondary Outcomes

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

Time frame: 3 weeks

Daily insulin dose

Change from baseline in daily insulin dose after 3 weeks of treatment

Time frame: 3 weeks

Body weight

Change from baseline in body weight after 3 weeks of treatment

Time frame: 3 weeks

Pain

Pain measured by visual analogue scale after 3 weeks of treatment

Time frame: 3 weeks

Patient satisfaction measured by a questionnaire

Patient satisfaction measured by a questionnaire after 3 weeks of treatment

Time frame: 3 weeks

Number of patients with hypoglycaemia

Number of patients with hypoglycaemia during 3 weeks

Time frame: 3 weeks

Number of hypoglycaemia episodes

Total number of phypoglycaemia episodes during 3 weeks

Time frame: 3 weeks

Number of episodes of insulin leakage at injection site

Central Contacts

Antonio Nicolucci, MD

CONTACT

+39 085 9047114 nicolucci@coresearch.it

Data from ClinicalTrials.gov

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