Which Needle Length for Injecting Insulin

Diabetes Mellitus Clinical Trial

Status Completed

Clinical Trial Summary

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’.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

• NCT number: NCT00292890
• Study type: Interventional
• Source: University Medical Center Groningen
• Status: Completed
• Phase: N/A
• Start date: January 2004
• Completion date: October 2004