Which Needle Length for Injecting Insulin

NCT00292890 | Completed

• 1 other identifier: 1-Kreugel
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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'.

Conditions

Diabetes Mellitus

Keywords

injection devices; injection technique; insulin needles; insulin administration

Outcome Measures

Primary Outcomes (1)

• HbA1c levels, insulin doses and the number of experienced hypoglycaemic events

Secondary Outcomes (1)

• blood glucose measurements and the experiences of the patients

Interventions

insulin needle DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older
• capable of reading the written information
• prepared to, and capable of signing an informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Centre Groningen

Groningen, Provincie Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bruce HR Wolffenbuttel, MD PhD

  University Medical Center Groningen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 15, 2006
• First Posted: February 16, 2006
• Study Start: January 1, 2004
• Study Completion: October 1, 2004
• Last Updated: February 16, 2006

Record last verified: 2005-01

Locations

NL (1)