Blood Glucose, LowNCT04486183
Effects of Different Methods Used to Take Blood Samples on Blood Glucose Measurements
A study testing capillary blood samples in people with Blood Glucose, Low, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
Aims and Objectives: The purpose of this study is to compare whether or not there is a difference between venous and capillary blood samples in blood glucose measurements and investigate the effects of different aseptic methods used in skin cleaning before collecting blood samples on measurement results. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Blood Glucose, Low
- What is being tested?
- capillary blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Nov 2017to 30 Apr 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- who had both upper extremities,
- good capillary saturation,
- blood glucose monitoring requests for OGTT,
- who were fasting for 8-12 hours before giving blood,
- who had requests for 75 gr sugar loading
- who volunteered to participate in the study.
Who cannot join
- who refused to participate in the study,
- whose capillary blood glucose could not be looked at after sugar loading.
Trial locations and contacts
1 site in 1 country.
About this study
Aims and Objectives: The purpose of this study is to compare whether or not there is a difference between venous and capillary blood samples in blood glucose measurements and investigate the effects of different aseptic methods used in skin cleaning before collecting blood samples on measurement results.
Background: Capillary blood glucose measurement is a frequently used measurement method in both clinical environments and the home environment. However, several different aseptic techniques are used in collecting blood samples for glucose measurement.
Design and Methods: This was a quasi-experimental study that was conducted with 109 patients who visited the blood collection unit of a University Hospital located in Western Turkey for 75 gr OGTT between November 2017 and April 2018. The capillary first and second blood drop values taken from the patients after fasting and at two hours following OGTT and capillary and venous blood glucose values were compared.
Read the detailed description
The data were collected by the researcher at the waiting room of the blood collection unit at a close distance to the lavatory. A nurse working at the venous blood sample unit collected fasting and 2 hours after OGTT venous blood samples from the individuals who arrived at the blood collection unit for 75 gr OGTT. All venous blood and capillary blood samples were obtained in a shorter time than 5 minutes. In this study, capillary blood samples were taken from the same participant in four different ways:
- As the first intervention, the middle finger of the individuals agreeing to participate in the study was rubbed and wiped with a cotton infused with 70% alcohol, and 10 seconds were given for it to dry. Afterwards, by perforating the finger with a lancet, firstly the first blood drop glucose value and then the second blood drop glucose value were measured.
- As the second intervention, after ensuring that the individuals washed their hands with soap at the lavatory of the blood collection unit and dried their hands with paper towels, the middle finger of the right hand was rubbed, perforated with a lancet, and firstly the first blood drop glucose value and then the second blood drop glucose value were measured.
- As the third intervention, for the individuals whose hands had been washed, the middle finger of the left hand was rubbed and wiped with 70% alcohol-infused cotton, and 10 seconds were given for it to dry. The finger was perforated with a lancet and the first and second blood drop glucose values were recorded.
- As the fourth intervention, 2 hours after the individuals drank a beverage containing 75 gr of sugar for OGTT, in a state where their hands had been washed, the finger was wiped with 70% alcohol, left to dry, perforated with a lancet, and the first and second blood drop glucose values were measured and recorded
- Conditions
- Blood Glucose, Low
- Being tested
- capillary blood samples
- Keywords
- Blood Glucose Measurements, Venous Blood, Capillary Blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capillary blood samplesOther
Also called capillary blood samples were taken from the same participant in four different ways
The patient's finger was wiped with alcohol, left to dry, and the first and second blood drops were read The patient was asked to wash their hands, their finger was perforated with a strip, and the first and second blood drops were read The finger of the patient whose hands had been washed was wiped with alcohol, left to dry, and the first and second blood drops were read Venous blood was collected for blood sugar measurement 2 hours after the patient had a beverage containing 75 gr sugar for OGTT The patient was ensured to wash their hands, their finger was wiped with alcohol, and the first and second blood drop glucose values were measured and recorded
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The data were collected by the researcher at the waiting room of the blood collection unit at a close distance to the lavatory. The capillary first and second blood drop values taken from the patients after fasting and at two hours following OGTT and capillary and venous blood glucose values were compared. Receives: Other: capillary blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form
10 questions on the sociodemographic characteristics of the participants such as age, sex, height-weight, status of DM diagnosis in the family, status of having another chronic disease and status of smoking and alcohol consumption
Measured: at 6-month
Data Record Form
The individuals' venous blood glucose values, capillary fasting blood glucose first and second blood drop values measured with aseptic techniques and the first and second blood drop values of the venous and capillary blood glucose 2 hours after OGTT were recorded into a "Data Record Form". As the glucometer device in the study, Roche's Accu-Chek® Performa Nano brand measurement device was used
Measured: at 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start27 Nov 2017
- Primary completion5 Dec 2017
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Glucose, LowStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This was a quasi-experimental study with a single group and simultaneous (matched) sample conducted with the purpose of examining whether or not there is a difference between venous and capillary blood samples in blood glucose level measurements and the effects of different methods used in skin cleaning before collecting blood samples on measurement results
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Eda Ergin, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486183
- Sponsor's protocol ID
- Eda ERGIN, PhD,RN
- Other IDs
- Ayten Zaybak
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ergin E, Zaybak A. Effects of Different Methods Used to Take Blood Samples on Blood Glucose Measurements. Clin Nurs Res. 2022 Jan;31(1):29-38. doi: 10.1177/10547738211024782. Epub 2021 Jul 5.
PubMed 34218680
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Methods Used to Take Blood Samples on Blood Glucose Measurements
- ClinicalTrials.gov ID
- NCT04486183
- Acronym / sponsor ID
- Eda ERGIN, PhD,RN
- Conditions
- Blood Glucose, Low
- Keywords
- Blood Glucose Measurements, Venous Blood, Capillary Blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 5 Dec 2017 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 24 Jul 2020 (actual)
- 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.
Aims and Objectives: The purpose of this study is to compare whether or not there is a difference between venous and capillary blood samples in blood glucose measurements and investigate the effects of different aseptic methods used in skin cleaning before collecting blood samples on measurement results.
Background: Capillary blood glucose measurement is a frequently used measurement method in both clinical environments and the home environment. However, several different aseptic techniques are used in collecting blood samples for glucose measurement.
Design and Methods: This was a quasi-experimental study that was conducted with 109 patients who visited the blood collection unit of a University Hospital located in Western Turkey for 75 gr OGTT between November 2017 and April 2018. The capillary first and second blood drop values taken from the patients after fasting and at two hours following OGTT and capillary and venous blood glucose values were compared.
Detailed description
The data were collected by the researcher at the waiting room of the blood collection unit at a close distance to the lavatory. A nurse working at the venous blood sample unit collected fasting and 2 hours after OGTT venous blood samples from the individuals who arrived at the blood collection unit for 75 gr OGTT. All venous blood and capillary blood samples were obtained in a shorter time than 5 minutes. In this study, capillary blood samples were taken from the same participant in four different ways:
- As the first intervention, the middle finger of the individuals agreeing to participate in the study was rubbed and wiped with a cotton infused with 70% alcohol, and 10 seconds were given for it to dry. Afterwards, by perforating the finger with a lancet, firstly the first blood drop glucose value and then the second blood drop glucose value were measured.
- As the second intervention, after ensuring that the individuals washed their hands with soap at the lavatory of the blood collection unit and dried their hands with paper towels, the middle finger of the right hand was rubbed, perforated with a lancet, and firstly the first blood drop glucose value and then the second blood drop glucose value were measured.
- As the third intervention, for the individuals whose hands had been washed, the middle finger of the left hand was rubbed and wiped with 70% alcohol-infused cotton, and 10 seconds were given for it to dry. The finger was perforated with a lancet and the first and second blood drop glucose values were recorded.
- As the fourth intervention, 2 hours after the individuals drank a beverage containing 75 gr of sugar for OGTT, in a state where their hands had been washed, the finger was wiped with 70% alcohol, left to dry, perforated with a lancet, and the first and second blood drop glucose values were measured and recorded
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This was a quasi-experimental study with a single group and simultaneous (matched) sample conducted with the purpose of examining whether or not there is a difference between venous and capillary blood samples in blood glucose level measurements and the effects of different methods used in skin cleaning before collecting blood samples on measurement results
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: capillary blood samplesThe data were collected by the researcher at the waiting room of the blood collection unit at a close distance to the lavatory. The capillary first and second blood drop values taken from the patients after fasting and at two hours following OGTT and capillary and venous blood glucose values were compared. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- who had both upper extremities,
- good capillary saturation,
- blood glucose monitoring requests for OGTT,
- who were fasting for 8-12 hours before giving blood,
- who had requests for 75 gr sugar loading
Key exclusion criteria (2 listed)
- who refused to participate in the study,
- whose capillary blood glucose could not be looked at after sugar loading.
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 |
|---|---|---|
| capillary blood samplesAlso: capillary blood samples were taken from the same participant in four different waysThe patient's finger was wiped with alcohol, left to dry, and the first and second blood drops were read The patient was asked to wash their hands, their finger was perforated with a strip, and the first and second blood drops were read The finger of the patient whose hands had been washed was wiped with alcohol, left to dry, and the first and second blood drops were read Venous blood was collected for blood sugar measurement 2 hours after the patient had a beverage containing 75 gr sugar for OGTT The patient was ensured to wash their hands, their finger was wiped with alcohol, and the first and second blood drop glucose values were measured and recorded | Other | Intervention |
Primary outcome
Patient Information Form
Time frame: at 6-month
10 questions on the sociodemographic characteristics of the participants such as age, sex, height-weight, status of DM diagnosis in the family, status of having another chronic disease and status of smoking and alcohol consumption
Data Record Form
Time frame: at 6-month
The individuals' venous blood glucose values, capillary fasting blood glucose first and second blood drop values measured with aseptic techniques and the first and second blood drop values of the venous and capillary blood glucose 2 hours after OGTT were recorded into a "Data Record Form". As the glucometer device in the study, Roche's Accu-Chek® Performa Nano brand measurement device was used
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 24 Jul 2020.
- Derived from this study: PubMed 34218680Ergin E, Zaybak A. Effects of Different Methods Used to Take Blood Samples on Blood Glucose Measurements. Clin Nurs Res. 2022 Jan;31(1):29-38. doi: 10.1177/10547738211024782. Epub 2021 Jul 5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capillary blood samples in people with Blood Glucose, Low, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
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 2 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 24 Jul 2020. 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 Turkey (Türkiye). 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?
Patient Information Form (time frame: at 6-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04486183, which also lists 1 linked publication.
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 24 Jul 2020.