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Which Needle Length for Injecting Insulin

U

University Medical Center Groningen (UMCG)

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Device: insulin needle

Study type

Interventional

Funder types

Other

Identifiers

NCT00292890
1-Kreugel

Details and patient eligibility

About

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'.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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