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
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Device: Indicator magnifying window (Izumi Planning Co.)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: October 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: Indicator magnifying window (Izumi Planning Co.)

IZUMI PLANNING CO,.LTD.Tokyo.Japan

Material: Polypropylene with polycarbonate lens


  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563419

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Young Min Cho, MD,PhD Seoul National University College of Medicine
  More Information

No publications provided

Responsible Party: Young Min Cho, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01563419     History of Changes
Other Study ID Numbers: magnifier
Study First Received: March 20, 2012
Last Updated: March 26, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Insulin
Diabetes
Low vision

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014