Clinical Usefulness of a Magnifier for Insulin Pen

NCT ID: NCT01563419

Last Updated: 2012-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

dialing up the selected dose of insulin pens without an indicator magnifying window

Group Type NO_INTERVENTION

No interventions assigned to this group

Magnifier

dialing up the selected dose of insulin pens clipped on an indicator magnifying window

Group Type EXPERIMENTAL

Indicator magnifying window (Izumi Planning Co.)

Intervention Type DEVICE

IZUMI PLANNING CO,.LTD.Tokyo.Japan

Material: Polypropylene with polycarbonate lens

Interventions

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Indicator magnifying window (Izumi Planning Co.)

IZUMI PLANNING CO,.LTD.Tokyo.Japan

Material: Polypropylene with polycarbonate lens

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Min Cho

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young Min Cho, MD,PhD

Role: STUDY_CHAIR

Seoul National University College of Medicine

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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magnifier

Identifier Type: -

Identifier Source: org_study_id

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