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Clinical Usefulness of a Magnifier for Insulin Pen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Young Min Cho, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01563419
First received: March 20, 2012
Last updated: March 26, 2012
Last verified: March 2012
History of Changes

March 20, 2012
March 26, 2012
October 2011
January 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01563419 on ClinicalTrials.gov Archive Site
  • the dosing accuracy [ Time Frame: from to start dialing up the selected dose to to complete dialing up, assessed up to 10 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: the duration of to complete filling up the questionnaires, an expected average of 10 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: the duration of to complete filling up the questionnaires, an expected average of 10 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: the duration of to complete filling up the questionnaires, an expected average of 10 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: the duration of to complete filling up the questionnaires, an expected average of 10 minutes ] [ Designated as safety issue: No ]
    By structured questionnaires, the investigators ask participants whether they prefer the use of a magnifier
  • 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 ] [ Designated as safety issue: No ]
    By structured questionnaires, the investigators ask participants whether they recommend the use of a magnifier to others.
Same as current
Not Provided
Not Provided
 
Clinical Usefulness of a Magnifier for Insulin Pen
Not Provided

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
Device: Indicator magnifying window (Izumi Planning Co.)

IZUMI PLANNING CO,.LTD.Tokyo.Japan

Material: Polypropylene with polycarbonate lens
  • No Intervention: Control
    dialing up the selected dose of insulin pens without an indicator magnifying window
  • Experimental: Magnifier
    dialing up the selected dose of insulin pens clipped on an indicator magnifying window
    Intervention: Device: Indicator magnifying window (Izumi Planning Co.)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01563419
magnifier
Not Provided
Young Min Cho, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Study Chair: Young Min Cho, MD,PhD Seoul National University, College of Medicine
Seoul National University Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP