Needle Length In Obese Insulin-Using Diabetic Subjects

Study Overview
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Brief Summary
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For the administration of insulin, different needles are available with a length from 5 to 12.7mm. Insulin injections with a needle of 8 mm is injected in a lifted skinfold, a 5 mm needle can by used without lifting a skinfold (1). In the Netherlands obese people (BMI ≥ 30) are usually advised to use an 8mm or even longer needle (1). Increased BMI and the thickness of the subcutaneous tissue slow insulin absorption (2, 3, 4), possibly related to reduced subcutaneous blood flow. Furthermore, the capillaries are located just under the skin and between the fat and muscle layer. This could possibly determine the absorbing speed (2). It is not know if the administration of insulin with a 5mm needle by obese people has a different influence on the HbA1c compared to longer needles. The hypothesis of this study is that for the purpose of insulin injections, a 5 mm needle can be used without negative effects on metabolic parameters in patients with Diabetes Mellitus (DM) and a Body Mass Index (BMI) ≥ 30.

Official Title
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The Influence of the Needle Length on Long Term Glycaemic Control in Insulin Using Obese Diabetic Subjects

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: insulin injection needle size


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female adult patients diagnosed with type 1 and type 2 diabetes mellitus, treated with insulin injections for at least one year and: using an insulin pen a BMI > 30 kg/m2 a skinfold thickness of >10 mm at the injection sites stable glycaemic control, with HbA1c between 6 and 10% capable of reading the written information prepared to, and capable of signing an informed consent Exclusion Criteria: Patients who: change their own insulin dosage and are not prepared to keep a record of these changes have hypoglycaemia unawareness are pregnant or wish to become pregnant have a BMI < 30 kg/m2 have a skinfold thickness <10mm have skin problems including lipodystrophy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Needle 5 mm | Device: insulin injection needle size<br>* The intervention in this study is a specific needle with a length of 5 mm and 8 mm to be used with an insulin pen.<br>|
| Active Comparator: 2<br>Needle length 8 mm | Device: insulin injection needle size<br>* The intervention in this study is a specific needle with a length of 5 mm and 8 mm to be used with an insulin pen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference of the patient and amount of experienced hypoglycaemic events, bruises, backflow of insulin, bleeding and pain (VAS-scale) |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c levels 1,5 anhydroglucitol and fructosamine levels Insulin dose |  | 4 months |