Diabetes MellitusNCT00292890
Which Needle Length for Injecting Insulin
A study testing insulin needle in people with Diabetes Mellitus, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- insulin needle
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2004to Oct 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Centre Groningen
Groningen, Provincie Groningen, 9700RB
About this study
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'.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- insulin needle
- Keywords
- injection devices, injection technique, insulin needles, insulin administration
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin needleDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c levels, insulin doses and the number of experienced hypoglycaemic events
Secondary outcomes (1)
blood glucose measurements and the experiences of the patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startJan 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Investigators
- Bruce HR Wolffenbuttel, MD PhD, Study chair, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292890
- Sponsor's protocol ID
- 1-Kreugel
- Status last verified
- Jan 2005
- First submitted
- 15 Feb 2006
- Last updated
- 16 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Needle Length for Injecting Insulin
- ClinicalTrials.gov ID
- NCT00292890
- Acronym / sponsor ID
- 1-Kreugel
- Conditions
- Diabetes Mellitus
- Keywords
- injection devices, injection technique, insulin needles, insulin administration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Oct 2004
- First posted
- 16 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin needle | Device | – |
Primary outcome
HbA1c levels, insulin doses and the number of experienced hypoglycaemic events
1 secondary outcome
blood glucose measurements and the experiences of the patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce HR Wolffenbuttel, MD PhD study chair
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insulin needle in people with Diabetes Mellitus, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c levels, insulin doses and the number of experienced hypoglycaemic events. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2006.