Clinical Usefulness of a Magnifier for Insulin Pen

Study Overview
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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.

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Indicator magnifying window (Izumi Planning Co.)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>dialing up the selected dose of insulin pens without an indicator magnifying window | |
| Experimental: Magnifier<br>dialing up the selected dose of insulin pens clipped on an indicator magnifying window | Device: Indicator magnifying window (Izumi Planning Co.)<br>* IZUMI PLANNING CO,.LTD.Tokyo.Japan Material: Polypropylene with polycarbonate lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time spent to complete dialing up insulin pens | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin, Diabetes, Low vision