Clinical trial NCT00292890: Which Needle Length for Injecting Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: injection devices
injection technique
insulin needles
insulin administration
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2006-02-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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'.

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c levels, insulin doses and the number of experienced hypoglycaemic events
Secondary outcomes:
measure: blood glucose measurements and the experiences of the patients
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Bruce HR Wolffenbuttel, MD PhD
role: STUDY_CHAIR
References: