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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014