Diabetes Mellitus
Conditions
Keywords
injection devices, injection technique, insulin needles, insulin administration
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.
Interventions
DEVICEinsulin needle
Sponsors
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c levels, insulin doses and the number of experienced hypoglycaemic events | — |
Secondary
| Measure | Time frame |
|---|---|
| blood glucose measurements and the experiences of the patients | — |
Countries
Netherlands
Outcome results
None listed