Clinical Usefulness of a Magnifier for Insulin Pen

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Indicator magnifying window (Izumi Planning Co.)

• Registration Number: NCT01563419
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-03
• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-26
• Last Update Submitted: 2012-03-26
• Study First Posted: 2012-03-27
• Last Update Posted: 2012-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Magnifier	Indicator magnifying window (Izumi Planning Co.)	dialing up the selected dose of insulin pens clipped on an indicator magnifying window

Primary Outcome Measures

Name	Time	Method
the time spent to complete dialing up insulin pens	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.

Secondary Outcome Measures

Name	Time	Method
the dosing accuracy	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.
the convenience in using insulin pens	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 self-confidence in using insulin pens	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 need for glasses in using insulin pens	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 preferences for the use of a magnifier	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 recommendation for the use of a magnifier	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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of