Needle Length In Obese Insulin-Using Diabetic Subjects

Phase 4

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: insulin injection needle size

• Registration Number: NCT00541372
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-09
• Study First Submitted QC: 2007-10-09
• Study First Posted: 2007-10-10
• Status Verified: 2009-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Last Update Submitted: 2009-03-13
• Last Update Posted: 2009-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	insulin injection needle size	Needle 5 mm
2	insulin injection needle size	Needle length 8 mm

Primary Outcome Measures

Name	Time	Method
Preference of the patient and amount of experienced hypoglycaemic events, bruises, backflow of insulin, bleeding and pain (VAS-scale)	4 months

Secondary Outcome Measures

Name	Time	Method
HbA1c levels 1,5 anhydroglucitol and fructosamine levels Insulin dose	4 months

Trial Locations

Locations (1)

University Medical Centre Groningen; 🇳🇱 Groningen, Netherlands