Clinical Usefulness of a Magnifier for Insulin Pen

March 26, 2012 updated by: Young Min Cho, Seoul National University Hospital
Insulin treatment is crucial for glucose control. Many patients with type 2 diabetes exhibit inadequate glycemic control in spite of combination of oral antidiabetic drugs and eventually need insulin therapy. Patients who need insulin therapy are older and have poor visual acuity, which predispose to inaccurate dosing and consequent hyper or hypoglycemia.In this study, the investigators examined the clinical usefulness of a magnifier for elderly diabetic patients who had used insulin pens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of diabetes mellitus
  • over 60 years old
  • who have self-injected insulin with insulin pens

Exclusion Criteria:

  • who have visual acuity less than 20/200 for each eye
  • who had surgery on his/her eyes within a week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
dialing up the selected dose of insulin pens without an indicator magnifying window
Experimental: Magnifier
dialing up the selected dose of insulin pens clipped on an indicator magnifying window
Device: Indicator magnifying window (Izumi Planning Co.)

IZUMI PLANNING CO,.LTD.Tokyo.Japan

Material: Polypropylene with polycarbonate lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the time spent to complete dialing up insulin pens
Time Frame: from to start dialing up the selected dose to to complete dialing up, assessed up to 10 minutes
The investigators ask participants to dial up the random dose of insulin pens between 30 and 40 and measured the time spent to complete dialing up.
from to start dialing up the selected dose to to complete dialing up, assessed up to 10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the dosing accuracy
Time Frame: from to start dialing up the selected dose to to complete dialing up, assessed up to 10 minutes
The investigators ask participants to dial up the random dose of insulin pens between 30 and 40 and check whether they dial up the selected dose correctly.
from to start dialing up the selected dose to to complete dialing up, assessed up to 10 minutes
the convenience in using insulin pens
Time Frame: the duration of to complete filling up the questionnaires, an expected average of 10 minutes
By structured questionnaires, the investigators ask participants about the convenience in dialing up to correct doses of insulin pens.
the duration of to complete filling up the questionnaires, an expected average of 10 minutes
the self-confidence in using insulin pens
Time Frame: the duration of to complete filling up the questionnaires, an expected average of 10 minutes
By structured questionnaires, the investigators ask participants about the self-confidence in dialing up to correct doses of insulin pens
the duration of to complete filling up the questionnaires, an expected average of 10 minutes
the need for glasses in using insulin pens
Time Frame: the duration of to complete filling up the questionnaires, an expected average of 10 minutes
By structured questionnaires, the investigators ask participants about the need for glasses in dialing up to correct doses of insulin pens
the duration of to complete filling up the questionnaires, an expected average of 10 minutes
the preferences for the use of a magnifier
Time Frame: the duration of to complete filling up the questionnaires, an expected average of 10 minutes
By structured questionnaires, the investigators ask participants whether they prefer the use of a magnifier
the duration of to complete filling up the questionnaires, an expected average of 10 minutes
the recommendation for the use of a magnifier
Time Frame: the duration of to complete filling up the questionnaires, an expected average of 10 minutes
By structured questionnaires, the investigators ask participants whether they recommend the use of a magnifier to others.
the duration of to complete filling up the questionnaires, an expected average of 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Young Min Cho, MD,PhD, Seoul National University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

March 20, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (Estimate)

March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

March 27, 2012

Last Update Submitted That Met QC Criteria

March 26, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • magnifier

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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