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Which Needle Length for Injecting Insulin

This study has been completed.
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00292890
First received: February 15, 2006
Last updated: NA
Last verified: January 2005
History: No changes posted
  Purpose

Background and aims:

  • In the Netherlands most patients with diabetes mellitus that are treated with insulin, use an insulin pen for insulin administration. The injection technique can influence the absorption rate of insulin.
  • The aim of this study is to compare the effect of insulin injections using a 5 mm insulin needle with insulin injections using a longer needle, on HbA1c, bloodglucose levels, hypoglycaemic events, bleeding, bruising, insulin leakage and pain perception.
  • Study Hypothesis: 'Insulin injected with needles of 5 mm can be given without a skinfold. The length of the needle will not influence HbA1c levels and bloodglucose levels’.

Condition Intervention
Diabetes Mellitus
 Device: insulin needle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • HbA1c levels, insulin doses and the number of experienced hypoglycaemic events

Secondary Outcome Measures:
  • blood glucose measurements and the experiences of the patients

Estimated Enrollment: 50
Study Start Date: January 2004
Estimated Study Completion Date: October 2004
Detailed Description:
  • In this randomised, clinical trial with cross-over design, 52 patients with Diabetes type 1 and 2 using a 8 or 12 mm needle, are randomised into two groups.
  • Group I starts using 5 mm needles for insulin administration, after 13 weeks group I returns to their previously used 8 or 12 mm needle
  • Group II continues using their own 8 or 12 mm needle, after 13 weeks group II starts using 5 mm needles for insulin administration.
  • During each visit the HbA1c level is measured and a copy is made of the logbook of the patient with the blood glucose measurements.
  • Insulin doses and number of experienced hypoglycaemic events are registered at each visit.
  • The opinion and experiences of the patients regarding the different needles are obtained by using a questionnaire.
  • Within-group analyses are computed, using the Wilcoxon signed Ranks Test. Between-group analyses are computed using the Mann-Whitney U test.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • males and females diagnosed with diabetes Type 1 or 2
  • using insulin for at least one year
  • using an insulin pen and a needle of 8-mm or longer
  • 18 years or older
  • capable of reading the written information
  • prepared to, and capable of signing an informed consent

Exclusion Criteria:

patients that

  • change their own insulin dosage and don't keep an administration of these changes
  • had an HbA1c that varied more than 15 % in the past year
  • use a needle of 5 or 6-mm
  • have hypoglycaemia unawareness
  • are pregnant or wanted to become pregnant
  • have a BMI < 18
  • have a skinfold thickness of 10 mm or less at the injection sites (abdomen and thigh)
  • had hemoglobinopathies which could limit the ability of haemoglobin to be glycated
  • had skin problems like lipodystrofie
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292890

Locations
Netherlands
University Medical Centre Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Study Chair: Bruce HR Wolffenbuttel, MD PhD University Medical Centre Groningen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00292890     History of Changes
Other Study ID Numbers: 1-Kreugel
Study First Received: February 15, 2006
Last Updated: February 15, 2006
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
injection devices
injection technique
insulin needles
insulin administration

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 23, 2013