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Needle Length In Obese Insulin-Using Diabetic Subjects (INOBESE)

This study has been completed.
Sponsor:
Collaborator:
Martini Hospital Groningen
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00541372
First received: October 9, 2007
Last updated: March 13, 2009
Last verified: March 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Influence of the Needle Length on Long Term Glycaemic Control in Insulin Using Obese Diabetic Subjects

Resource links provided by NLM:

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
Experimental: 1
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.
Active Comparator: 2
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 by University Medical Centre Groningen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013