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OpenTrials
Completed

NCT Number: NCT00292890

Which Needle Length for Injecting Insulin

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'.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Groningen

Groningen, Provincie Groningen, 9700RB, Netherlands

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

insulin needle

Device

Primary outcomes

  1. HbA1c levels, insulin doses and the number of experienced hypoglycaemic events

Secondary outcomes

  1. blood glucose measurements and the experiences of the patients

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Important dates

Study start
2004
Study completion
2004
First posted
Feb 16, 2006
Registry last updated
Feb 16, 2006

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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