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OpenTrials
Completed

NCT Number: NCT01563419

Clinical Usefulness of a Magnifier for Insulin Pen

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indicator magnifying window (Izumi Planning Co.)

Device

IZUMI PLANNING CO,.LTD.Tokyo.Japan

Material: Polypropylene with polycarbonate lens

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 27, 2012
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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