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Completed

NCT Number: NCT01745549

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Primary outcomes

  1. hematic fructosamine levels

    Time frame: Change from baseline in fructosamine levels after 3 weeks of treatment

Secondary outcomes

  1. mean amplitude of glucose excursions (MAGE)

    Time frame: Change from baseline in MAGE after 3 weeks of treatment

  2. pain

    Time frame: questionnaire at the end of the treatments (at 6 weeks)

    visual analogic scale (VAS) 1-10

  3. leakage at the site injection

    Time frame: number of episodes of leakage during the treatment (3 weeks)

    visual scale

  4. hypoglycemia

    Time frame: number of episodes of hypoglycemia during the treatment (3 weeks)

  5. insulin dosage

    Time frame: Change from baseline in insulin dosage after 3 weeks of treatment

  6. patient's weight

    Time frame: Change from baseline in weight after 3 weeks of treatment

  7. patient's satisfaction

    Time frame: questionnaire at the end of the treatments (at 6 weeks)

    VAS scale

Sponsors and collaborators

Lead sponsor

Consorzio Mario Negri Sud

Other

Collaborators

  • Artsana S.p.a.

Registry information

Official study title

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

Acronym: AGO01

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 10, 2012
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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