NCT04486183

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2017

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

8 days

First QC Date

July 14, 2020

Last Update Submit

July 23, 2020

Conditions

Keywords

Blood Glucose MeasurementsVenous BloodCapillary Blood

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    at 6-month

Study Arms (1)

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.

Other: capillary blood samples

Interventions

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

Also known as: capillary blood samples were taken from the same participant in four different ways
Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • who refused to participate in the study,
  • whose capillary blood glucose could not be looked at after sugar loading.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir Bakırçay University

Izmir, 35665, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor,Department of Fundamentals Nursing,

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 24, 2020

Study Start

November 27, 2017

Primary Completion

December 5, 2017

Study Completion

April 30, 2018

Last Updated

July 24, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations