Needle Length In Obese Insulin-Using Diabetic Subjects

Diabetes Mellitus Clinical Trial

— INOBESE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541372
• Other study ID #: BWO-07001
• Status: Completed
• Phase: Phase 4
• First received: October 9, 2007
• Last updated: March 13, 2009
• Start date: September 2007
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• insulin injection needle size
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.

Locations

Country	Name	City	State
Netherlands	University Medical Centre Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Martini Hospital Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preference of the patient and amount of experienced hypoglycaemic events, bruises, backflow of insulin, bleeding and pain (VAS-scale)		4 months	No
Secondary	HbA1c levels 1,5 anhydroglucitol and fructosamine levels Insulin dose		4 months	No