Clinical Usefulness of a Magnifier for Insulin Pen

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01563419

Enrollment

Registered

2012-03-27

Start date

2011-10-31

Completion date

2012-01-31

Last updated

2012-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Insulin, Diabetes, Low vision

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.

Interventions

DEVICEIndicator magnifying window (Izumi Planning Co.)

IZUMI PLANNING CO,.LTD.Tokyo.Japan Material: Polypropylene with polycarbonate lens

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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 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.
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026