Which Needle Length for Injecting Insulin

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292890
• Other study ID #: 1-Kreugel
• Status: Completed
• Phase: N/A
• First received: February 15, 2006
• Last updated: February 15, 2006
• Start date: January 2004
• Est. completion date: October 2004

Study information

• Verified date: January 2005
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

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’.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• insulin needle

Locations

Country	Name	City	State
Netherlands	University Medical Centre Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c levels, insulin doses and the number of experienced hypoglycaemic events
Secondary	blood glucose measurements and the experiences of the patients