The main objective is to investigate if the use of 5mm needles has a positive effect concerning hypoglycemic events and local complaints like bruising, bleeding, back flow of insulin and pain compared to 8mm needles, and to receive information about…
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
hypoglycemia, local complaints, and patients preference.
Secondary outcome
HbA1c , fructosamine, serum 1,5-Anhydroglucitol
Background summary
For the administration of insulin, different needles are available with a
length from 5 to 12.7mm. Insulin injections with a needle of 8 mm is injected
in a lifted skinfold, a 5 mm needle can by used without lifting a skinfold (1).
In the Netherlands obese people (BMI >= 30) are usually advised to use an 8mm or
even longer needle (1). Increased BMI and the thickness of the subcutaneous
tissue slow insulin absorption (2, 3, 4), possibly related to reduced
subcutaneous blood flow. Furthermore, the capillaries are located just under
the skin and between the fat and muscle layer. This could possibly determine
the absorbing speed (2). It is not know if the administration of insulin with a
5mm needle by obese people has a different influence on the HbA1c compared to
longer needles. The hypothesis of this study is that for the purpose of insulin
injections, a 5 mm needle can be used without negative effects on metabolic
parameters in patients with Diabetes Mellitus (DM) and a Body Mass Index (BMI)
>= 30.
Study objective
The main objective is to investigate if the use of 5mm needles has a positive
effect concerning hypoglycemic events and local complaints like bruising,
bleeding, back flow of insulin and pain compared to 8mm needles, and to receive
information about the preference of the patients.
The secondary objective is to investigate if insulin administrated with a 5mm
needle is not inferior with respect to metabolic control compared to insulin
injections with an 8mm needle.
Study design
A clinical trial with a cross-over design, with 2 periods, comparing the use of
the shorter and the standard needle in randomized order.
Intervention
The intervention in this study is a specific needle with a length of 5 mm and 8
mm to be used with an insulin pen.
Study burden and risks
Burden: patients of one group will be requested to return to the longer needle.
In a previous study (5) some patients refused to return to the longer needle.
The patient will be asked to answer a questionnaire. Blood samples will be
taken at the regular check up-visits of the patient. Taking a blood sample for
HbA1c control is general practise.
Benefit: all patients who are prepared to join the study will have a check up
of their injection sites. Patients with lipodystrophy will not be included but
will get advice in injection technique. Included patients have the opportunity
to try and compare the different needles and can continue using this needle
after the study unless the results of this study show otherwise. During the
regular laboratory check a blood sample will be taken for 1,5 anhydroglucitol
and fructosamine. After the study these extra parameters can give the physician
who treats the patient and the patient extra information about the glucose
regulation. This information can help in improving the regulation.
Risk: the risk of injecting insulin is hypoglycaemia. Patients already use and
inject insulin. Though previous study has not shown a risk of hypoglycaemia
when switching to a different needle length patients will be advised to be
extra alert for hypoglycaemic events when switching to a different needle.
Hanzeplein 1
9700 RB Groningen
Nederland
Hanzeplein 1
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
male and female adult patients diagnosed with Type 1 or Type 2 diabetes and using insulin for at least one year and have insulin injections with an insulin pen, have a BMI >= 30, have a skinfold thickness of > 10 mm at the injection sites, stable glycaemic control, hba1c between 6-10%, are capable of reading the written information and are prepared to, and capable of signing an informed consent.
Exclusion criteria
patients who: change their own insulin dosage and are not prepared to keep an administration of these changes, are hypoglycaemia unaware, are pregnant or wish to become pregnant, have a BMI < 30, have a skinfold thickness of <= 10mm, have skin problems including lipodystrophy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL12394.042.07 |