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Needle Length In Obese Insulin-Using Diabetic Subjects (INOBESE)
This study has been completed.
Study NCT00541372   Information provided by University Medical Centre Groningen
First Received: October 9, 2007   Last Updated: March 13, 2009   History of Changes

October 9, 2007
March 13, 2009
September 2007
March 2009   (final data collection date for primary outcome measure)
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 ]
Preference of the patient and amount of experienced hypoglycaemic events, bruises, backflow of insulin, bleeding and pain (VAS-scale) [ Time Frame: 4 months ]
Complete list of historical versions of study NCT00541372 on ClinicalTrials.gov Archive Site
HbA1c levels 1,5 anhydroglucitol and fructosamine levels Insulin dose [ Time Frame: 4 months ] [ Designated as safety issue: No ]
HbA1c levels 1,5 anhydroglucitol and fructosamine levels Insulin dose [ Time Frame: 4 months ]
 
Needle Length In Obese Insulin-Using Diabetic Subjects
The Influence of the Needle Length on Long Term Glycaemic Control in Insulin Using Obese Diabetic Subjects

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.

 
Phase IV
Interventional
Supportive Care, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Diabetes Mellitus
Device: insulin injection needle size
  • Experimental: Needle 5 mm
  • Active Comparator: Needle length 8 mm
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
130
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00541372
B.H.R. Wolffenbuttel, Univ Med Ctr Groningen
BWO-07001
University Medical Centre Groningen
Martini Hospital Groningen
Principal Investigator: Bruce HR Wolffenbuttel, MD PhD University Medical Centre Groningen
University Medical Centre Groningen
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP