Clinical Usefulness of a Magnifier for Insulin Pen

NCT01563419 | Completed

• 1 other identifier: magnifier
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Insulin; Diabetes; Low vision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• the dosing accuracy

  from to start dialing up the selected dose to to complete dialing up, assessed up to 10 minutes

• the convenience in using insulin pens

  the duration of to complete filling up the questionnaires, an expected average of 10 minutes

• the self-confidence in using 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

  the duration of to complete filling up the questionnaires, an expected average of 10 minutes

• the preferences for the use of a magnifier

  the duration of to complete filling up the questionnaires, an expected average of 10 minutes

Study Arms (2)

Control

NO INTERVENTION

dialing up the selected dose of insulin pens without an indicator magnifying window

Magnifier

EXPERIMENTAL

dialing up the selected dose of insulin pens clipped on an indicator magnifying window

Device: Indicator magnifying window (Izumi Planning Co.)

Interventions

Indicator magnifying window (Izumi Planning Co.) DEVICE

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

Magnifier

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of diabetes mellitus
• over 60 years old
• who have self-injected insulin with insulin pens

You may not qualify if:

• who have visual acuity less than 20/200 for each eye
• who had surgery on his/her eyes within a week

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance; Vision, Low

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Young Min Cho, MD,PhD

  Seoul National University College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 27, 2012
• Study Start: October 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 27, 2012

Record last verified: 2012-03

Locations

KR (1)