NCT00292890CompletedNot Applicable
Which Needle Length for Injecting Insulin
University Medical Center Groningen2 sites in 1 country50 target enrollmentStarted: January 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- HbA1c levels, insulin doses and the number of experienced hypoglycaemic events
Study Overview
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'.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
HbA1c levels, insulin doses and the number of experienced hypoglycaemic events
Secondary Outcomes
- blood glucose measurements and the experiences of the patients
Investigators
Study Sites (2)
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