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

March 17, 2014 updated by: Antonio Nicolucci, Consorzio Mario Negri Sud

Efficacy, Safety and Satisfaction of the New Pen Needle 33G x 4 mm 33G x 4 mm: Cross-over Randomized Controlled Clinical Trial. Studio AGO 01

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BG
      • Treviglio, BG, Italy, 24047
        • UO Malattie Metaboliche e Diabetologia - Ospedale di Treviglio-Caravaggio
    • BS
      • Brescia, BS, Italy, 25123
        • UO Diabetologia per Trattamento e Educazione dei Diabetici - Spedali Civili di Brescia
    • CO
      • Mariano Comense, CO, Italy, 22066
        • U.O.S. Diabetologia e Malattie Metaboliche - PO Cantù - Mariano Comense
    • RM
      • Roma, RM, Italy, 00157
        • Struttura Complessa Dietologia-Diabetologia Malattie Metaboliche - Ospedale Pertini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: needle 4 mm gauge 33
Needle for insulin pen, 4 mm long and with a diameter of 33 gauge (the smaller needle)
Device: Needle for insulin pen, 4 mm long and with a diameter of 33 gauge
Active Comparator: needle 4 mm gauge 32
Needle for insulin pen, 4 mm long and with a diameter of 32 gauge
Device: Needle for insulin pen, 4 mm long and with a diameter of 32 gauge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hematic fructosamine levels
Time Frame: Change from baseline in fructosamine levels after 3 weeks of treatment
Change from baseline in fructosamine levels after 3 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean amplitude of glucose excursions (MAGE)
Time Frame: Change from baseline in MAGE after 3 weeks of treatment
Change from baseline in MAGE after 3 weeks of treatment
pain
Time Frame: questionnaire at the end of the treatments (at 6 weeks)
visual analogic scale (VAS) 1-10
questionnaire at the end of the treatments (at 6 weeks)
leakage at the site injection
Time Frame: number of episodes of leakage during the treatment (3 weeks)
visual scale
number of episodes of leakage during the treatment (3 weeks)
hypoglycemia
Time Frame: number of episodes of hypoglycemia during the treatment (3 weeks)
number of episodes of hypoglycemia during the treatment (3 weeks)
insulin dosage
Time Frame: Change from baseline in insulin dosage after 3 weeks of treatment
Change from baseline in insulin dosage after 3 weeks of treatment
patient's weight
Time Frame: Change from baseline in weight after 3 weeks of treatment
Change from baseline in weight after 3 weeks of treatment
patient's satisfaction
Time Frame: questionnaire at the end of the treatments (at 6 weeks)
VAS scale
questionnaire at the end of the treatments (at 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorzio Mario Negri Sud

Collaborators

Artsana SpA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

December 5, 2012

First Submitted That Met QC Criteria

December 6, 2012

First Posted (Estimate)

December 10, 2012

Study Record Updates

Last Update Posted (Estimate)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGO01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe