Diabetes MellitusNCT05976191
Comparison of Fasting Blood Glucose Measurements From Fingertip and Intravenous on Patient Satisfaction in Patients With Diabetes Mellitus
A study testing Patients whose blood glucose is measured intravenously and from the fingertip in people with Diabetes Mellitus, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
Trial summary
The study was designed as a randomized controlled experimental study in order to compare the fasting blood glucose values measured by puncturing the fingertips and using the intravenous route of patients diagnosed with diabetes mellitus, and to determine the effect on patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Patients whose blood glucose is measured intravenously and from the fingertip
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 30 Sep 2023
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- No advanced hearing and vision problems
- Able to speak and understand Turkish
- Easy to communicate
- literate
- Agreeing to participate in the research voluntarily
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- Patients who are hospitalized
- Regular finger blood sugar monitoring,
- Patients with an intravenous vascular access date within the first 24 hours
- Patients who had been diagnosed with Type 2 Diabetes Mellitus for at least one year were.
Who cannot join
- Those who are treated with sedative drugs
- Patients using antipsychotic medication
- Patients with continuous drug infusion through the intravenous line
- Patients whose intravenous vascular access date has passed 24 hours
- Patients in unconscious, confused, apathetic state
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Istanbul University-Cerrahpaşa (IUC)
Istanbul, Şişli, 34381
AYSEGUL OZBAKAN, 00905423047687, aysegulozbakan@icloud.com
ARZU ERKOC, 00905552735500, arzu.erkochut@iuc.edu.tr
- Recruiting
Istanbul University-Cerrahpaşa (IUC)
Istanbul, Şişli, 34381
AYSEGUL OZBAKAN, 05423047687, aysegulozbakan@icloud.com
ARZU ERKOÇ, 05552735500, arzu.erkochut@iuc.edu.tr
About this study
Official title: Istanbul University Cerrahpaşa-IUC
The study was designed as a randomized controlled experimental study in order to compare the fasting blood glucose values measured by puncturing the fingertips and using the intravenous route of patients diagnosed with diabetes mellitus, and to determine the effect on patient satisfaction. The blood glucose measurement via the intravenous catheter has an effect on increasing the comfort of the patient compared to the fingertip measurement. It is thought that information can be provided to increase patient satisfaction.
- Conditions
- Diabetes Mellitus
- Being tested
- Patients whose blood glucose is measured intravenously and from the fingertip
- Keywords
- Diabetes mellitus, Fear of finger piercing, patient satisfaction, blood glucose measurement
- Medical subject headings
- Diabetes Mellitus, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients whose blood glucose is measured intravenously and from the fingertipBehavioural
A satisfaction survey will be conducted after these patients have previously examined their blood glucose via intravenous route, then fingertip blood glucose will be measured and a satisfaction survey will be applied.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Patients whose blood glucose is measured intravenously and from the fingertip Receives: Behavioral: Patients whose blood glucose is measured intravenously and from the fingertip |
| control group | No intervention | Patients with fingertip blood glucose measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose Measurement Patient Satisfaction Form
Does intravenous blood glucose measurement have a positive effect on patient satisfaction compared to fingertip blood glucose measurement?
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Mar 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
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.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment This research was designed in a pretest posttest randomized controlled experimental type
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYSEGUL, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976191
- Sponsor's protocol ID
- 2022/476
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Istanbul University Cerrahpaşa-IUC
- ClinicalTrials.gov ID
- NCT05976191
- Acronym / sponsor ID
- 2022/476
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus, Fear of finger piercing, patient satisfaction, blood glucose measurement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 4 Aug 2023 (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.
The study was designed as a randomized controlled experimental study in order to compare the fasting blood glucose values measured by puncturing the fingertips and using the intravenous route of patients diagnosed with diabetes mellitus, and to determine the effect on patient satisfaction. The blood glucose measurement via the intravenous catheter has an effect on increasing the comfort of the patient compared to the fingertip measurement. It is thought that information can be provided to increase patient satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Crossover Assignment This research was designed in a pretest posttest randomized controlled experimental type
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Patients whose blood glucose is measured intravenously and from the fingertipPatients whose blood glucose is measured intravenously and from the fingertip |
| control group | No intervention | –Patients with fingertip blood glucose measurement |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years and older
- No advanced hearing and vision problems
- Able to speak and understand Turkish
- Easy to communicate
- literate
Key exclusion criteria (5 listed)
- Those who are treated with sedative drugs
- Patients using antipsychotic medication
- Patients with continuous drug infusion through the intravenous line
- Patients whose intravenous vascular access date has passed 24 hours
- Patients in unconscious, confused, apathetic state
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 |
|---|---|---|
| Patients whose blood glucose is measured intravenously and from the fingertipA satisfaction survey will be conducted after these patients have previously examined their blood glucose via intravenous route, then fingertip blood glucose will be measured and a satisfaction survey will be applied. | Behavioural | experimental group |
Primary outcome
Blood Glucose Measurement Patient Satisfaction Form
Time frame: four months
Does intravenous blood glucose measurement have a positive effect on patient satisfaction compared to fingertip blood glucose measurement?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- 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.
Istanbul University-Cerrahpaşa (IUC)
Istanbul, Turkey (Türkiye)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients whose blood glucose is measured intravenously and from the fingertip in people with Diabetes Mellitus, run by Istanbul University - Cerrahpasa at 2 sites 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 10 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose Measurement Patient Satisfaction Form (time frame: four months). 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 4 Aug 2023.