Clinical Usefulness of a Magnifier for Insulin Pen

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563419
• Other study ID #: magnifier
• Status: Completed
• Phase: N/A
• First received: March 20, 2012
• Last updated: March 26, 2012
• Start date: October 2011
• Est. completion date: January 2012

Study information

• Verified date: March 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Indicator magnifying window (Izumi Planning Co.)
IZUMI PLANNING CO,.LTD.Tokyo.Japan Material: Polypropylene with polycarbonate lens

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No