Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292890
Status:
COMPLETED
Last Update Posted:
2006-02-16
First Post:
2006-02-15
Brief Title:
Which Needle Length for Injecting Insulin
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None