Needle Length In Obese Insulin-Using Diabetic Subjects

NCT00541372 | Completed Phase 4

• 1 other identifier: BWO-07001
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

  4 months

Secondary Outcomes (1)

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

  4 months

Study Arms (2)

1

EXPERIMENTAL

Needle 5 mm

Device: insulin injection needle size

2

ACTIVE COMPARATOR

Needle length 8 mm

Device: insulin injection needle size

Interventions

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.

1; 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Martini Hospital Groningen: collaborator

Study Sites (1)

University Medical Centre Groningen

Groningen, Netherlands

Location

Related Publications (1)

• Kreugel G, Keers JC, Kerstens MN, Wolffenbuttel BH. Randomized trial on the influence of the length of two insulin pen needles on glycemic control and patient preference in obese patients with diabetes. Diabetes Technol Ther. 2011 Jul;13(7):737-41. doi: 10.1089/dia.2011.0010. Epub 2011 Apr 10.

  PMID: 21476936 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bruce HR Wolffenbuttel, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 9, 2007
• First Posted: October 10, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 17, 2009

Record last verified: 2009-03

Locations

NL (1)