Needle Length in Obese Insulin-Using Diabetic Subjects - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus	Device: insulin injection needle size	Phase IV

MedlinePlus related topics:

Diabetes Obesity

ChemIDplus related topics:

Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

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

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:

Preference of the patient and amount of experienced hypoglycaemic events, bruises, backflow of insulin, bleeding and pain (VAS-scale) [ Time Frame: 4 months ]

Secondary Outcome Measures:

HbA1c levels 1,5 anhydroglucitol and fructosamine levels Insulin dose [ Time Frame: 4 months ]

Estimated Enrollment:	130
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Experimental Needle 5 mm	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.
2: Active Comparator Needle length 8 mm	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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541372

Contacts


Contact: G. Kreugel, RN		g.kreugel@int.umcg.nl

Locations


Netherlands
	University Medical Centre Groningen	Recruiting
	Groningen, Netherlands

Sponsors and Collaborators

University Medical Centre Groningen

Investigators


Principal Investigator:	Bruce HR Wolffenbuttel, MD PhD	University Medical Centre Groningen

More Information

Study ID Numbers:	BWO-07001
First Received:	October 9, 2007
Last Updated:	October 9, 2007
ClinicalTrials.gov Identifier:	NCT00541372
Health Authority:	Netherlands: Dutch Health Care Inspectorate

Study placed in the following topic categories:

Obesity

Metabolic Diseases

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2008

Sponsored by:	University Medical Centre Groningen
Information provided by:	University Medical Centre Groningen
ClinicalTrials.gov Identifier:	NCT00541372