Which Needle Length for Injecting Insulin

Study Overview
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Brief Summary
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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
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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.

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: insulin needle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: insulin needle|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c levels, insulin doses and the number of experienced hypoglycaemic events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose measurements and the experiences of the patients |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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injection devices, injection technique, insulin needles, insulin administration