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Completed

NCT Number: NCT00541372

Needle Length In Obese Insulin-Using Diabetic Subjects

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Centre Groningen

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin injection needle size

Device

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.

Primary outcomes

  1. Preference of the patient and amount of experienced hypoglycaemic events, bruises, backflow of insulin, bleeding and pain (VAS-scale)

    Time frame: 4 months

Secondary outcomes

  1. HbA1c levels 1,5 anhydroglucitol and fructosamine levels Insulin dose

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Martini Hospital Groningen

Registry information

Official study title

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

Acronym: INOBESE

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 10, 2007
Registry last updated
Mar 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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