Which Needle Length for Injecting Insulin

February 15, 2006 updated by: University Medical Center Groningen

Background and aims:

  • In the Netherlands most patients with diabetes mellitus that are treated with insulin, use an insulin pen for insulin administration. The injection technique can influence the absorption rate of insulin.
  • The aim of this study is to compare the effect of insulin injections using a 5 mm insulin needle with insulin injections using a longer needle, on HbA1c, bloodglucose levels, hypoglycaemic events, bleeding, bruising, insulin leakage and pain perception.
  • Study Hypothesis: 'Insulin injected with needles of 5 mm can be given without a skinfold. The length of the needle will not influence HbA1c levels and bloodglucose levels'.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • In this randomised, clinical trial with cross-over design, 52 patients with Diabetes type 1 and 2 using a 8 or 12 mm needle, are randomised into two groups.
  • Group I starts using 5 mm needles for insulin administration, after 13 weeks group I returns to their previously used 8 or 12 mm needle
  • Group II continues using their own 8 or 12 mm needle, after 13 weeks group II starts using 5 mm needles for insulin administration.
  • During each visit the HbA1c level is measured and a copy is made of the logbook of the patient with the blood glucose measurements.
  • Insulin doses and number of experienced hypoglycaemic events are registered at each visit.
  • The opinion and experiences of the patients regarding the different needles are obtained by using a questionnaire.
  • Within-group analyses are computed, using the Wilcoxon signed Ranks Test. Between-group analyses are computed using the Mann-Whitney U test.

Study Type

Interventional

Enrollment

50

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

  • Netherlands
      • Groningen, Netherlands, 9700RB
        • University Medical Centre Groningen

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:

  • males and females diagnosed with diabetes Type 1 or 2
  • using insulin for at least one year
  • using an insulin pen and a needle of 8-mm or longer
  • 18 years or older
  • capable of reading the written information
  • prepared to, and capable of signing an informed consent

Exclusion Criteria:

patients that

  • change their own insulin dosage and don't keep an administration of these changes
  • had an HbA1c that varied more than 15 % in the past year
  • use a needle of 5 or 6-mm
  • have hypoglycaemia unawareness
  • are pregnant or wanted to become pregnant
  • have a BMI < 18
  • have a skinfold thickness of 10 mm or less at the injection sites (abdomen and thigh)
  • had hemoglobinopathies which could limit the ability of haemoglobin to be glycated
  • had skin problems like lipodystrofie

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c levels, insulin doses and the number of experienced hypoglycaemic events

Secondary Outcome Measures

Outcome Measure
blood glucose measurements and the experiences of the patients

Collaborators and Investigators

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

Sponsor

University Medical Center Groningen

Investigators

  • Study Chair: Bruce HR Wolffenbuttel, MD PhD, University Medical Center Groningen

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

January 1, 2004

Study Completion

October 1, 2004

Study Registration Dates

First Submitted

February 15, 2006

First Submitted That Met QC Criteria

February 15, 2006

First Posted (Estimate)

February 16, 2006

Study Record Updates

Last Update Posted (Estimate)

February 16, 2006

Last Update Submitted That Met QC Criteria

February 15, 2006

Last Verified

January 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-Kreugel

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.

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