Which Needle Length for Injecting Insulin
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00292890|
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : February 16, 2006
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 or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Device: insulin needle||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2004|
|Study Completion Date :||October 2004|
- HbA1c levels, insulin doses and the number of experienced hypoglycaemic events
- blood glucose measurements and the experiences of the patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292890
|University Medical Centre Groningen|
|Groningen, Netherlands, 9700RB|
|Study Chair:||Bruce HR Wolffenbuttel, MD PhD||University Medical Center Groningen|