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

Sponsors and Collaborators:	University Medical Centre Groningen Martini Hospital Groningen
Information provided by:	University Medical Centre Groningen
ClinicalTrials.gov Identifier:	NCT00541372

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

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Obesity

Drug Information available for: Insulin

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HbA1c levels 1,5 anhydroglucitol and fructosamine levels Insulin dose [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	September 2007
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

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

Locations

Netherlands
University Medical Centre Groningen
Groningen, Netherlands

Sponsors and Collaborators

University Medical Centre Groningen

Martini Hospital Groningen

Investigators

Principal Investigator:

Bruce HR Wolffenbuttel, MD PhD

University Medical Centre Groningen

More Information

No publications provided

Responsible Party:	Univ Med Ctr Groningen ( B.H.R. Wolffenbuttel )
Study ID Numbers:	BWO-07001
Study First Received:	October 9, 2007
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00541372 History of Changes
Health Authority:	Netherlands: Dutch Health Care Inspectorate

Study placed in the following topic categories:

Obesity
Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on August 28, 2009